Abstract of thesis entitled

“An Evidence-based Guideline of using Superficial Heat therapy for

Adult patients with Acute Low Back Pain”

Submitted by

LAI TSZ NING

For the Master of Nursing

At The University of Hong Kong

In July 2014

Low back pain is a common health problem. Around 80% of adults experience an

episode of low back pain in their lifetime. The prevalence of low back pain is the

highest during middle age.

People who suffered from acute low back pain may have the problem resolved

within a few months.However, without proper intervention, the condition could

deteiorate and result in increasing disability, losing working productivity, thus

reducing the quality of life.

Superficial heat therapy is proved to be effective in reducing pain of patients with

acute low back pain, especially heat wrap therapy which was supported by six quality

studies. It was found to be superior to oral analgesic.

This dissertation is a translational nursing research which aims at developing an

evidence-based guidline of using Superficial heat therapy to relieve pain in patients

with acute low back pain.

Seven randomized controlled stuides were identified through searching database

and critically appraised by Scottish Intercollegiate Guidelines Network. Useful data

from the studies was summarised and analysed in this paper.

The proposed protocol are designated to be implemented in Orthopaedics and

Traumatology wards in a public hospital. Therefore, implementation potential

including transferability, feasibility and cost-benefit ratio are evaluated for

establishing the superficial heat therapy guidelines. A continuous low-level heat wrap

is recommended as a mean of superficial heat therapy. The heat wrap is suggested to

apply for 8 hours in daytime for 2 consecutive days.

Furthermore, a program team was formed to facilitate communication with the

stakeholders in order to seek their approval. A pilot test is conducted to assess the

feasibility of the protocol in the implementation plan. In order to assess the

effectiveness of the protocol, an evaluation plan was initied and outcomes to be

achieved was compromised by the program team.

By implementing this newly developed evidence-based superficial Heat Therapy

guideline for patients with acute low back pain, it is anticipated that the pain of those

patients can be alleviated and their quality of life be maintained.

An Evidence-based Guideline of using Superficial Heat

therapy for Adult patients with Acute Low Back Pain

by

LAI TSZ NING

B.Nurs. H.K.U.

A thesis submitted in partial fulfillment of the requirements for

The Master of Nursing

At The University of Hong Kong

July 2014

i

Declaration

I declare that this thesis represents my own work, except where due

acknowledgement is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a degree,

diploma or other qualifications.

Signed……………………………………………………………..

LAI TSZ NING

ii

Acknowledgements

I would like to express my deepest gratitude to my supervisor Ms. Rebecca Poon,

who has inspired me and provided tremendous support and encouragement. Without her

guidance, I would not be able to advance my professional knowledge and complete this

dissertation.

I would like to express my heartily thanks to my supervisor Dr. Angela Leung. She

has selflessly offered lots of assistance and advice throughout the preparation of this

dissertation. This dissertation would not be possible without her support.

Besides, I would like to express my sincere thanks to my partner, Miss Chan

Hoi-yan who has stood by me and provided the needed supports during these 2 years’

master programme.

Last but not the least, I would like to express my blessings to my family,

colleagues, friends and classmates, especially Mr. Lo Kwok-chun, for their tolerance,

encouragement and support in every aspect during my study of the master programme.

iii

Contents

Declaration…………………………………………………………………….....i

Acknowledgements……………………………………………………………...ii

Table of Contents…………………………………………………….………….iii

List of Appendices………………………………………………….…………..vii

Abbreviations………………………………………………………………… viii

CHAPTER 1 INTRODUCTION

1.1 Background .......................................................................... 1

1.2 Affirming Needs ................................................................... 2

1.3 Significance ........................................................................... 5

1.4 Objectives ............................................................................. 5

1.5 Research Question ............................................................... 6

CHAPTER 2 CRITICAL APPRAISAL

2.1 Search Strategy .................................................................... 7

2.1.1 Inclusion criteria ............................................................................................... 7

2.1.2 Exclusion criteria ............................................................................................. 7

2.1.3 Keywords and Search Engines ......................................................................... 7

2.2 Appraisal Strategies ............................................................. 8

2.3 Results ................................................................................... 8

2.3.1 Search Result .................................................................................................... 8

2.3.2 Data Extraction ................................................................................................. 9

2.3.3 Critical appraisal .............................................................................................. 9

2.4 Summary and Synthesis .................................................... 10

iv

2.4.1 Summary of data ............................................................................................ 10

2.4.2 Synthesis of Data............................................................................................ 12

2.4.2.1 Sample Characteristics ............................................................................................ 12

2.4.2.2 Interventions ........................................................................................................... 13

2.4.2.3 Effect of Interventions ............................................................................................. 14

2.4.2.4 Outcome measurements ......................................................................................... 17

2.5 Implications ........................................................................ 18

CHAPTER 3 IMPLEMENTATION POTENTIAL

3.1 Target setting ...................................................................... 22

3.2 Target Audience ................................................................. 22

3.3 Transferability .................................................................... 24

3.3.1 Proposed setting ............................................................................................. 24

3.3.2 Proposed audiences ........................................................................................ 24

3.3.3 Philosophy of care .......................................................................................... 25

3.3.4 Sufficiency of clients benefiting from innovation ......................................... 26

3.3.5 Time for Implementation & Evaluation ......................................................... 26

3.4 Feasibility ............................................................................ 27

3.4.1 Freedom of nurse to carry out the intervention .............................................. 27

3.4.2 Interfere current staff functions ...................................................................... 27

3.4.3 Administrative Support .................................................................................. 27

3.4.4 Consensus ....................................................................................................... 28

3.4.5 Requirement of special skills and staff training ............................................. 30

3.4.6 Availability of Essential equipment & facilities ............................................. 30

3.4.7 Availability of Evaluation tools ...................................................................... 30

3.5 Cost-Benefit Ratio .............................................................. 31

3.5.1 Potential Risk ................................................................................................. 31

3.5.2 Potential Risk of maintaining current practice ............................................... 31

3.5.3 Potential Benefits ........................................................................................... 32

v

3.5.4 Cost for implementation of protocol .............................................................. 32

3.5.4.1 Set up cost ............................................................................................................... 32

3.5.4.2 Operational Cost ...................................................................................................... 34

3.5.5 Cost –benefit ratios ........................................................................................ 34

CHAPTER 4 EVIDENCE-BASED PRACTICE PROTOCOL

4.1 Title ...................................................................................... 36

4.2 Objectives ........................................................................... 36

4.3 Target User ......................................................................... 36

4.4 Target Population ............................................................... 36

4.5 Rating system of Recommendations ................................ 37

4.6 Grades of Recommendations ............................................ 37

CHAPTER 5 IMPLEMENTATION PLAN

5.1 Communication Plan ......................................................... 40

5.1.1 Identifying Stakeholders ................................................................................ 40

5.1.2 Forming Program Team ................................................................................. 41

5.1.3 Process of Communication Plan .................................................................... 42

5.1.3.1 Initiation Stage......................................................................................................... 42

5.1.3.2 Guiding Stage ........................................................................................................... 45

5.1.3.3 Sustaining Stage ...................................................................................................... 45

5.2 Pilot Study .......................................................................... 46

5.2.1 Study Design .................................................................................................. 47

5.2.2 Objectives ....................................................................................................... 47

vi

5.2.3 Target Population and Program Intervention ................................................. 47

5.2.4 Outcomes Measurements ............................................................................... 48

5.2.5 Evaluation of the guideline ............................................................................ 49

CHAPTER 6 EVALUATION PLAN

6.1 Identifying Outcomes and Outcomes Measurements .... 50

6.1.1 Patient outcomes ............................................................................................ 50

6.1.2 Healthcare Provider Outcomes ...................................................................... 51

6.1.3 System Outcomes ........................................................................................... 52

6.2 Determining Nature and Number of Clients .................. 52

6.2.1. Nature of Clients ........................................................................................... 52

6.2.2 Sampling Method ........................................................................................... 52

6.2.3 Sample Size .................................................................................................... 53

6.2.4 Duration of Program ...................................................................................... 53

6.3 Data Collection and Method of Analysis ......................... 54

6.3.1 Data Analysis Designs.................................................................................... 54

6.3.2 Time for Outcome Measurements .................................................................. 54

6.3.3 Method of Analysis ........................................................................................ 54

6.4 Basis for an effective change of practice ......................... 55

CHAPTER 7 CONCLUSTION………………………………………….56

APPENDICES………………………………………………………………....58

REFERENCES…………………………………………………………….….91

vii

List of appendices

Appendix I: History of Searching Studies ............................................................... 58

Appendix II: Table of Evidence ................................................................................ 59

Appendix III: Methodology Checklists .................................................................... 66

Appendix IV: SIGN Grading System 1999-2012 ..................................................... 80

Appendix V: Summary table of Levels of Evidence of relevant studies ................ 81

Appendix VI: Cost for Implementation of protocol ................................................ 82

Appendix VII: Comparison of the cost between Current Practice and Superficial

Heat Therapy .................................................................................... 83

Appendix VIII: SIGN Grading System 1999 – 2012:

Grades of recommendations .......................................................... 84

Appendix IX: Timeframe for Superficial Heat Therapy Program for acute Low

Back Pain .......................................................................................... 85

Appendix X: Operational Flow of Superficial Heat therapy in Pilot Test ............ 86

Appendix XI: Pain Chart .......................................................................................... 87

Appendix XII: Assessment chart for Patient using Superficial Heat therapy ..... 88

Appendix XIII: Nurses’ Evaluation form for Superficial Heat Therapy

Program .......................................................................................... 89

Appendix XIV: Calculation of Sample Size ............................................................. 90

viii

Abbreviations

AC

APN

Assistant Concultant

Advanced Practice Nurse

CCE Cluster Chief Executive

COS Chief of Service

DOM Department Operation Manager

EN Enrolled Nurse

GMN

MO

General Manager of Nursing

Medical Officer

NC Nursing Consultant

NRS Numeric Rating Scale

O&T Orthopaedics and Traumatology

Q&A Question and Answer

RN Registered Nurse

SIGN Scottish Intercollegiate Guidelines Network

VRS Verbal Rating Scale

VAS Visual Analog Scale

WM Ward Manager

1

Chapter 1

Introduction

1.1 Background

Low Back pain is one of the common health problems. Around 80% of adults

experience once in a lifetime. The prevalence of low back pain is the highest

during middle age with the point prevalence of 11.9% and 1-month prevalence of

23.2% (Hoy et al., 2012).

There is no universal classification of low back pain. According to national

clinical guidelines from Europe and the United Kingdom, low back pain can be

classified as acute when it persists for less than 6 weeks, sub-acute between 6

weeks and 3 months and chronic when it lasts for longer than 3 months (Koes et

al., 2010). Signs and symptoms of low back pain may resolve within a few

months in 90% of cases with acute low back pain. However, without proper

intervention, some cases will proceed to recurrent or chronic problems and

residual trunk muscle dysfunction (Hides et al, 1994). These result in increasing

disability, losing working productivity and reducing quality of life (Pengel et al.,

2003). In addition, from a psychosocial prospective, anxiety and depression are

associated with low back pain. People with low back pain are more likely to

develop depression and anxiety disorder (Mok & Lee, 2008).

2

In order to prevent functional loss from acute low back pain, physical activity

and early initiation of rehabilitative exercises are recommended (Mayer et al.,

2005). However, people experience acute pain episode will be limited to perform

physical exercise, or even reluctant to participate.

Therefore, the alleviation of acute low back pain is important and necessary.

1.2 Affirming Needs

According to the admission statistical record at the Orthopaedics &

Traumatology departments of a public hospital where I work, over 70% patients

were admitted for acute low back pain. Current treatments for acute low back pain

include oral, intravenous or intramuscular analgesic, bed resting for 1-2 days and

referral to physiotherapy for physical exercise.

However, by clinical experience, over 40% of patients consider the current

treatment not effective in relieving the pain. Patients complain of epigastric pain,

nausea and vomiting after taking medications (Drug office, 2013a). Some patients

even request more medications for pain relief. This leads to more serious effect

such as gastrointestinal disturbance, poor appetite which induced poor nutrition

absorption (Drug office, 2013a). Dizziness and tiredness may cause as a result

which prolong bed resting time and delay of starting physical exercise.

3

Besides, sleep disturbance and insomnia are common associated problems in

patients with low back pain. Sleeping problem is associated with pain of 60%

prevalence (Alsaadi et al., 2011). Patients refuse to have physical exercise due to

lack of energy and prolong bed resting time, worsening the low back pain and

delay recovery (Waddell, Feder & Lewis, 1997). Moreover, they are more prone

to using sleeping pills which may cause severe side effects such as convulsion and

paranoid psychosis (Drug office, 2013b). The medical costs and length of

hospitalization are increased.

Superficial heat therapy is one of the common non-pharmacological

interventions for low-back pain. It is a safe and non-invasive treatment (Chou &

Huffman, 2007). Nurses can apply it to patients in need based on their

professional knowledge and judgments.

This superficial heat therapy is an application of topical heat by variety of

modalities over the pain area of the lower back. The heat stimulates

thermo-receptors in the skin and deeper tissues. According to the Gate Control

Theory (Melzack and Wall 1965), heat stimulates the impulse of large diameter

sensory fibers which close the gate in spinal cord. Transmission of painful signal

is thus decreased and pain reduced (Candler, Preece & Lister, 2002). There are

different modalities in superficial heat therapy, for example hot water bottles, hot

4

towels, electric heat pads and heat wrap (French et al., 2011).

Various studies have shown positive result of superficial heat therapy in

reducing low back pain (Kinkade, 2007). Some studies show that superficial heat

therapy is superior in pain relief to oral medications in treating low back pain

(Kettenmann et al., 2007; Nadler et al., 2002). Patients have preference in

superficial heat therapy to oral analgesic (Kettenmann et al., 2007). Other studies

also indicate that superficial heat therapy helps improve quality of sleep

(Kettenmann et al., 2007, Nadler et al., 2003).

Other countries, for example the United States, have recommended the use of

topical heat therapy in treatment of acute low back pain and applied it into clinical

practice (Chou et al., 2007). The Hospital Authority in Hong Kong also suggests

using heat therapy for relieving low back pain (HA, 2013) but it is not a common

routine practice in proposed ward.

Patients benefit from better pain controls are able to undergo earlier

rehabilitation exercise and maintain quality of life. Therefore, it is essential to

evaluate the effectiveness of using superficial heat therapy in reducing acute low

back pain and the methodology for application in local setting should also be

considered.

5

1.3 Significance

Superficial heat therapy is a kind of non-pharmacological intervention and

could be applied to patients in need by nurses based on knowledge and assessment.

It enhances nurses’ autonomy to provide better care to patient and raise patient’s

satisfaction. In addition, patients can benefit from better pain control away from

increasing risk of medication’s side effect. Patients with acute low back pain can

remain active in participating physical activity and maintain quality of life.

Moreover, burden of hospital-based medical care expanse could also be relieved

due to reduced consumption of additional medications and decreased length of

hospitalization.

Besides, evidenced based practice integrates clinical expertise and patient’s

value with research evidence support. (Sackett et al., 1996) It improved patient’s

pain intensity by providing higher quality of care since it incorporates the latest

research evidence.

1.4 Objectives

The objectives of this study are

1) To review and critically appraise the published research which evaluate the

effectiveness of using superficial heat therapy in reducing pain of patients with

6

acute low back pain

2) To develop an evidence-based guidelines for nurses in providing quality care

to patients with acute low back pain.

3) To assess the implementation potential of the guidelines which include

transferability, feasibility and cost-effectiveness

4) To develop a plan for implementing new innovation including a

communication plan with stakeholders

5) To develop an evaluation plan to assess the effectiveness of the proposed

protocol

1.5 Research Question

Is superficial heat therapy effective in reducing pain of patients with acute low

back pain compared with usual orthopaedics care?

7

Chapter 2

Critical Appraisal

2.1 Search Strategy

2.1.1 Inclusion criteria

The studies should be published in English, accessible in full text and the

publication year after 2002. Only randomized controlled trials studies could be

selected.

2.1.2 Exclusion criteria

Studies included participants aged less than 18, with the complaint of chronic

low back pain were excluded. Studies that included participants with low back

pain with radiculopathy were also excluded

Trials of deep heating intervention, for example, microwave diathermy and

ultrasound, were excluded. Besides, studies which given co-interventions which

could not isolate the effects of heat from other therapy were excluded too.

2.1.3 Keywords and Search Engines

Keywords were used for searching eligible studies which include “Acute low

8

back pain”, “back pain”, “Superficial heat therapy”, “thermotherapy” and “pain”.

A total of 3 databases were used for systematic search which are Pubmed,

CINAHL via EBSCOHOST and British Nursing Index via Proquest.

2.2 Appraisal Strategies

Those randomized controlled trials were appraised by using Critical

Appraisal: Notes and Checklist (2012) from Scottish Intercollegiate Guidelines

Network (SIGN). The level of evidence of those selected studies would be rated

according to the Grading System 1999-2012 from Scottish Intercollegiate

Guidelines Network (SIGN).

2.3 Results

2.3.1 Search Result

After using those keywords separately and in combination with each other via

three databases with consideration of inclusion and exclusion criteria, a total of

seven randomized controlled studies were chosen which all from Pubmed

(Kettenmann et al., 2007; Tao & Bernacki, 2005; Mayer et al., 2005; Nuhr et al.,

2004; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002). No studies

were retrieved from CINAHL via EBSCOHOST and British Nursing Index via

9

Proquest. The search was done on 18th June, 2013. The searching history and

details were presented in Appendix I.

Those 7 randomized controlled studies were appraised and graded by using

SIGN. The details of methodology checklist and grading system were shown in

Appendix III & IV.

2.3.2 Data Extraction

All useful data from the studies would be extracted into Table of Evidence.

The details of the table were listed in Appendix II.

2.3.3 Critical appraisal

All seven trials reported as randomized. Only two studies described the

randomization methods by using computer-generated codes (Mayer et al., 2005;

Nuhr et al., 2004). Concealment method was used in only one of the studies (Nuhr

et al., 2004) while the remaining studies were not reported. Single blinding was

carried out in five of the studies which one study blinded to participants (Tao &

Bernacki, 2005) and four studies blinded to investigators. (Nuhr et al., 2004;

Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002).

10

One trial reported zero dropout rate and all data were successfully analyzed

(Tao & Bernacki, 2005). The other six trials had an acceptable dropout rate ranged

from 2% to 21% (Kettenmann et al., 2007; Mayer et al., 2005; Nuhr et al., 2004;

Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002). Intention to treat

was undertaken in four studies to analysis the data (Mayer et al., 2005; Nadler et

al., 2003a; Nadler et al., 2003b; Nadler et al., 2002) and per protocol analysis was

carried out in two studies (Kettenmann et al., 2007; Nuhr et al., 2004).

Seven selected studies were appraised by Scottish Intercollegiate Guidelines

Network (SIGN), the level of evidence were ranged from 1- to 1+. 6 studies were

rated as 1+ (Tao & Bernacki, 2005; Mayer et al., 2005; Nuhr et al., 2004; Nadler

et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002) while 1 study was rated as

1- (Kettenmann et al., 2007). The Summary table of levels of evidence was listed

in Appendix V.

2.4 Summary and Synthesis

2.4.1 Summary of data

The sample size of seven studies varied from 30 to 371. The mean age of

participants varied from 30-56. The trials included patients with acute low back

pain or a mix of acute and sub-acute low back pain. All seven trials reported clear

11

inclusion and exclusion criteria. For example, eligible participants should be over

18 and able to follow the instructions, those with history of low back pain over 3

months must be excluded.

Two types of superficial heat therapy were examined in seven studies which

were continuous low-level heat wrap therapy and active warming with electric

blanket. Continuous low-level heat wrap therapy was a wearable heat wrap made

of layers of cloth-like material that contain heat-generating ingredients. These

ingredients heat up to 40oC when exposure to air within 30 minutes and this

temperature could maintain continuously for 8 hours. The heat wrap was applied

on the lumbar region and participants were allowed mobile while wearing it. This

device was safe and approved by Food and Drug Administration in the United

States (Kettenmann et al., 2007; Tao & Bernacki, 2005; Mayer et al., 2005; Nadler

et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002). Heat wrap was used either

in the day time for 2-5 days or throughout 3 consecutive nights.

For the active warming with electric blanket therapy, the blanket temperature

was set to 42oC by heating system (Nuhr et al., 2004). The intervention time of

using electric blanket was during transportation.

Pain was assessed in all studies with different measurement tools which include

0-100mm visual analogue scale (VAS), 6-point verbal rating scale (VRS) and 0-10

12

numeric rating scale (NRS). The pain intensities were measured before and after

the treatment with subsequently measurement taken ranged from 2 to 14 days

(Kettenmann et al., 2007; Tao & Bernacki, 2005; Mayer et al., 2005; Nuhr et al.,

2004; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002).

2.4.2 Synthesis of Data

2.4.2.1 Sample Characteristics

The sample size was small in two trials which included 30 and 43 participants

respectively without formal power calculation (Kettenmann et al., 2007; Tao &

Bernacki, 2005). The remaining five trials had effective sample size with power

analysis. Four trials had a power of 80% or above at 5% level of confidence

(Mayer et al., 2005; Nuhr et al., 2004; Nadler et al., 2003a; Nadler et al., 2003b)

while one trial had a power of 90% at 2.5% level of confidence (Nadler et al.,

2002).

The mean of age of six trials ranged from 30-42 (Tao & Bernacki, 2005;

Mayer et al., 2005; Nuhr et al., 2004; Nadler et al., 2003a; Nadler et al., 2003b;

Nadler et al., 2002). One trial had older age group which the mean of age was 56

(Kettenmann et al., 2007).

13

All studies reported the participants were suffered from acute low back pain.

However, according to the classification approved by Europe and United

Kingdom, there was only one study included acute low back pain participants

(Nuhr, 2004), while a mix of acute and sub-acute low back pain participants was

included in six studies (Kettenmann et al., 2007; Tao & Bernacki, 2005; Mayer et

al., 2005; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002). Although

data of acute low back pain cannot be differentiated from those studies with mixed

population, superficial heat wrap therapy was proved to be effective for not only

acute low back pain, but also sub-acute low back pain patients.

2.4.2.2 Interventions

Six studies examined a continuous low-level heat wrap therapy as the

intervention (Kettenmann et al., 2007; Tao & Bernacki, 2005; Mayer et al., 2005;

Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002) and one study used

active warming with electric blanket as intervention (Nuhr et al., 2004). Nuhr et al.

(2004) conducted a study by using active warming with electric blanket during

emergency transportation. Nadler et al. (2003b) examined the effect of overnight

use of heat wrap therapy for 3 consecutive nights. The remaining trials used the

14

heat wrap therapy for daytime use. Three trials used it for 2 (Nadler et al., 2002),

4 (Kettenmann et al., 2007) and 5 consecutive days (Mayer et al., 2005)

respectively and two trials used it for 3 consecutive days (Tao & Bernacki, 2005;

Nadler et al., 2003a).

Heat wrap therapy was well tolerated and no serious adverse events occurred

during the study. Three trials reported minor adverse effect of skin redness after

use of the heated wrap but all can be resolved without intervention (Nadler et al.,

2003a; Nadler et al., 2003b; Nadler et al., 2002). A total of 2 out of 208

participants who used heat wrap in the daytime experienced skin redness (Nadler

et al., 2003a; Nadler et al., 2002) and 4 participants out of 33 got erythema by

using heat wrap throughout the night (Nadler et al., 2003b) .There was no adverse

event occurred in the use of active warming with electric blanket.

2.4.2.3 Effect of Interventions

2.4.2.3.1 Comparison 1: Heat therapy versus non-heat therapy or oral

placebo

In the study of Nuhr et al. (2004), it compared the active warming electric

blanket with non-heat woolen blanket. The active warming group had

significantly reduction in pain. (p<0.01) It showed a statistically significant

15

benefit of a heated blanket compared to a non-heated woolen blanket immediately

after treatment (Pain score mean difference: -32.3 vs +0.8; Scale Range 0 to 100)

(Nuhr et al., 2004).

Two studies compared the effect of heated wrap with oral placebo. Results

showed that pain relief was significantly greater in heat wrap than the oral placebo.

In the study of Nadler et al. (2003a), heat wrap group was 2.89 times greater pain

relief than the oral placebo group. (p<0.04) Both studies also showed that there

was a significantly extended pain relief (on days 4 and 5) in heat wrap group even

the removal of intervention on day 3 (p<0.00001; p<0.00005) (Nadler et al.,

2003a; Nadler et al., 2003b).

2.4.2.3.2 Comparison 2: Heat therapy versus pharmacological interventions

Kettenmann et al. (2007) compared heat wrap with oral analgesics, the

heatwrap therapy treatment was more effective in reducing pain on day 3 and day

4 with statistically significance. (p<0.02; p<0.042) However, considering the

limitations of this study, such as small sample size (n=30) without formal power

calculations carried out, about 20% drop out rate and uneven sex distribution

between the control group and treatment group, the results would be in risk of bias

(Kettenmann et al., 2007).

16

Nadler et al. (2002) conducted a study to compare the heat wrap therapy with

acetaminophen and ibuprofen, heat wrap group demonstrated significant

improvements in pain relief as compared with acetaminophen and ibuprofen.

(p=0.00001; p=0.00001) The effect was also sustained in the heat wrap group for

2 more days after removal of heat wrap (Nadler et al., 2002).

2.4.2.3.3 Comparison 3: Heat therapy versus non-pharmacological

interventions

Tao X. & Bernacki, R.J. (2005) conducted a study to compare heat wrap with

education. The pain intensity was taken at day 1-4, day 7 and day 14. The heat

wrap therapy had significantly reduced the pain intensity from day 1 to day 14

compared with education. (p<0.05) The pain intensity was dramatically reduced

during 3-day treatment. Pain relief was also taken at the same time. Pain relief

was significantly greater than education group during the 3-day treatment and the

day after. (p<0.05) However, no significant difference at day 7 (p=0.24) and day

14 (p=0.15) (Tao & Bernacki, 2005).

Study of Mayer et al. (2005) also compared the heat wrap with exercise alone

and educational booklet alone. The measurement was taken at day 2, day 4 and

day 7. No significance difference in pain relief at day 2. At day 4, the pain relief

17

was greater in heat wrap than education. (0=0.026) However, a greater number of

female were assigned to the control group compared with other treatment groups.

This gender imbalance may bias the outcome. There was also no blinding in this

study which weakened the results.

Besides, this study also combined the heat wrap with exercise, and compared it

with heat wrap alone, exercise alone and booklet alone. The heat wrap with

exercise group had significantly greater pain relief than exercise and booklet on

day 7. Heat wrap with exercise group had almost 30 times greater pain relief than

booklet (p=0.003) (Mayer et al., 2005).

2.4.2.4 Outcome measurements

Pain was assessed in all studies with either in the form of pain relief or pain

intensity. Four studies used 6-point verbal rating scale (VRS) to measure pain

relief (Mayer et al., 2005; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al.,

2002). Two studies used 0-100mm visual analog scale (VAS) to measure pain

intensity (Kettenmann et al., 2007; Nuhr et al., 2004). One study measured both

pain relief and pain intensity by using 6-point VRS and 0-10 numeric rating scale

(NRS) (Tao & Bernacki, 2005). All indicators evaluated the effect of superficial

heat therapy in reducing pain significantly with consistent or stable results.

18

In the study of Tao X. & Bernacki, E.J. (2005) which used both pain relief and

pain intensity measurements, the difference between these two indictors was

evaluated. It showed that pain intensity scale was more sensitive and stable

compared with pain relief. As the result in pain intensity showed dramatically

reduction at the beginning and kept consistent afterwards, the pain relief became

less useful. Pain intensity was a better indicator to show the rate of change in pain.

Both VAS and NRS are commonly used tools for measuring pain intensity.

They are reliable, valid and appropriate for use in clinical practice (Williamson &

Hoggart, 2005). NRS is easier for administration and recording comparatively.

Moreover, NRS is preferred by patient because of its simplicity (Williamson &

Hoggart, 2005). It is also widely used in hospital setting in Hong Kong.

2.5 Implications

Seven randomized controlled studies were appraised. Two types of superficial

heat therapy, which were continuous low level heat wrap therapy and electric

warm blanket, were examined for either acute low back pain participants or a

mixed population with acute and sub-acute low back pain. Both therapies were

better than non-heat therapies or oral placebo in pain relief. Six trials used heat

wrap as intervention and proved that heat wrap therapy was superior to either

19

pharmacological or non-pharmacological interventions with statistically

significant result.

Although 6 studies applied heat wrap as intervention, the duration of treatment

was different. Study of Kettenmann et al (2007) applied heat wrap for 4 hours for

4 consecutive days. The result was considered as low effectiveness due to the low

level of evidence comparatively. Another study applied heat wrap for 8 hours for 5

consecutive days (Mayer et al., 2005), the results of the study might be biased due

to the gender imbalance between groups. Therefore effectiveness of that study was

considered as low. Two studies used heat wrap therapy for 8 hours for 3

consecutive days showed dramatic reduction in pain but small sample size and

insufficient sample characteristics provided (Tao & Bernacki, 2005; Nadler et al.,

2003a). The effectiveness from these 2 studies was needed to be considered. Study

of Nadler et al, (2003b) showed greatest pain relief result by administration of

heat wrap for 8 hours for 3 consecutive nights. However, there was 12% risk of

minor adverse effect, like erythema occur compared with 0.9% risk used in the

daytime. One study with effective sample size exhibited significant pain relief by

using heat wrap for 8 hours for 2 consecutive days (Nadler et al., 2002).

All studies either use pain relief or pain intensity as an indicator of pain.

However, pain intensity was a better indicator as it could show the changes of

20

pain where pain relief became less useful. (Tao & Bernacki, 2005) Visual Analog

Scale and Numeric Rating Scale are commonly used tools in measuring pain

intensity. They are reliable and sensitive. Numeric Rating Scale is easier to use

and more preferable by patients because of its simplicity compared with Visual

Analog Scale. It is also widely used in clinical practice.

Heat wrap therapy allowed mobilization compared with electric warm blanket.

It was more appropriate for using in the clinical setting so as promoting early

rehabilitation exercise. Study of Mayer et al., (2005) indicated that heat wrap plus

exercise produce greater pain relief than exercise alone. Although there was no

sufficient data to prove that whether heat wrap plus exercise had more pain

reduction or similar result than heat wrap alone, this showed that with additional

heat wrap therapy, the effect of pain relief was enhanced.

On the other hand, study of Nadler et al. (2003b) showed that heat wrap therapy

was significantly beneficial to improve quality of sleep. Another study of

Kettenmann et al. (2007) also suggested that heat wrap therapy could help in

better night sleep. Further study on effectiveness of superficial heat therapy on

quality of sleep was encouraged in future.

To sum up, superficial heat therapy is effective in reducing pain among patients

with acute and sub-acute low back pain. Heat wrap therapy is more appropriate in

21

the clinical setting compared with using elective warm blanket. Patients can

remain active and can do the physical exercise when wearing heat wrap. Thus

their quality of life can be maintained.

In my clinical working place, an acute Orthopaedics & Traumatology (O&T)

ward in a public hospital, over 70% of patients were admitted with acute low back

pain. By clinical observation, people tend to seek for medical advice when the

pain persists for a week. Therefore, there are no patients admitted with sub-acute

low back pain. Considering the patient’s characteristics in target setting, it is

worthy and important to develop an evidence-based heat wrap protocol by

synthesizing all useful data for acute low back pain patients.

22

Chapter 3

Implementation Potential

There are several modalities in superficial heat therapy, for example, hot water

bottles and electric heat pad. Heat wrap therapy is proved to be effective with

evidence-based support in the last chapter. Therefore, heat wrap therapy is decided

to be introduced into proposed protocol.

This chapter will evaluate the implementation potential of proposed protocol.

The transferability, feasibility and cost-benefit ratio will be assessed (Polit & Beck,

2004).

3.1 Target setting

The target setting for the implementation of heat wrap therapy is Orthopaedics

and Traumatology (O&T) wards in a public hospital. There are totally 4 acute

O&T wards, including 2 male and 2 female wards. The bed stat of the O&T

department is over 200. People with acute low back pain are admitted to O&T

wards for orthopedics treatment such as medication and physiotherapy.

3.2 Target Audience

According to the statistical admission record, over 70% patients are admitted

23

with acute low back pain and the majority is adult patients. Those patients will be

the target population of the proposed program.

Moreover, they must be ambulatory and cognitive intact which can follow

instructions. Female patients are required to have negative urine pregnancy test.

Those patients with any evidences or history of radiculopathy, other neurologic

deficit or spinal surgery will be excluded to this protocol (Tao & Bernacki, 2005;

Mayer et al., 2005; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002).

According to the Gate Control Theory (Melzack and Wall, 1965), heat therapy is

effective in low back pain which caused by muscle spasm by reducing tension in

muscle trigger point (Candler, Preece & Lister., 2002). Therefore, those patients

who suffer from neurological pain are not benefited from this protocol.

Besides, patients with hypersensitivity to heat or any skin lesions on the lumbar

region must be excluded to this protocol (Kettenmann et al., 2007; Tao &

Bernacki, 2005; Mayer et al., 2005; Nadler et al., 2003a; Nadler et al., 2003b;

Nadler et al., 2002). Heat wrap is used and applied on the lumbar region to

provide superficial heat therapy. Continuously using heat wrap for those patients

will increase risk of skin abrasions and deterioration of wound condition. For the

sake of patient safety, this kind of patients is also not recommended for applying

this protocol.

24

3.3 Transferability

3.3.1 Proposed setting

The setting of studies included community-based research facilities,

(Kettenmann et al., 2007; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al.,

2002;), out-patient medical facilities (Mayer et al., 2005), out-patient clinic (Tao

& Bernacki, 2005) and during emergency transport (Nuhr et al., 2004). Although

those settings are not as same as the target settings, there are number of patients

with acute low back pain admitted in O&T wards. Therefore the innovation can be

transferred to the proposed setting.

3.3.2 Proposed audiences

The participants of 6 studies were a mix of sub-acute and acute low back pain

adult patients. Those eligible patients were ambulatory. Those studies excluded

patients with any evidence or history of radiculopathy or other neurologic deficits,

history of back surgery and skin lesions on the lumbar region. (Kettenmann et al.,

2007; Mayer et al., 2005; Tao & Bernacki, 2005; Nadler et al., 2003a; Nadler et al.,

2003b; Nadler et al., 2002). The inclusion and exclusion criteria of the studies are

25

similar with the characteristics of the target population. Therefore, the findings are

transferrable.

3.3.3 Philosophy of care

The mission of our Orthopaedics and Traumatology department is to enhance

and regain patient‘s capacity to get back to community by providing

“client-oriented holistic care” through continuous quality improvement, education

and research, multidisciplinary approach and professionals development. The

philosophy of superficial heat therapy is to relieve patient’s back pain in order to

enhance their rehabilitation and minimize the complications, such as residual

trunk muscle dysfunction and depression. (Hides et al., 1994; Mok & Lee, 2008)

This innovation is developed based on evidence and research with quality

justification. It aims at enhancing patient’s quality of life by improving current

practice which is corporate the mission of O&T department. This innovation is

client-oriented approach which their daily life activities can be maintained under

the intervention.

Those philosophies of care of the innovation are consistent with the philosophy

prevailing in practice setting. Therefore heat wrap therapy for patients with acute

low back pain is transferrable.

26

3.3.4 Sufficiency of clients benefiting from innovation

According to the admission statistics in O&T department, there are over 70%

patients admitted with acute low back pain. After considering the inclusion criteria

of this innovation, it is estimated that there is around 600 clients annually, which

is sufficiently a large number, benefiting from this heat wrap therapy.

3.3.5 Time for Implementation & Evaluation

The time for implementation is different in those 6 studies using heat wrap

ranged from 4 days to 14 days (Kettenmann et al., 2007; Tao & Bernacki, 2005;

Mayer et al., 2005; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002).

After considering the methodology and result among those 6 studies,the

findings from study of Nadler et al (2002) is the most precise with 90% power at

2.5% level of confidence. Therefore the time for implementation is set as 4 days

which includes 2-day intervention with 2 days of follow up (Nadler et al., 2002).

It is transferrable to the proposed setting as its short-term measurement.

Pain intensity will be used for impact evaluation. It will be first measured

before applying heat therapy, then daily measure for consecutive 4 days.

27

3.4 Feasibility

3.4.1 Freedom of nurse to carry out the intervention

Heat wrap therapy is a safe and non-pharmacological intervention. This

intervention has to be applied with doctor’s prescription. However, nurses have

the freedom to continue or terminate the superficial heat therapy according to

clinical judgment.

3.4.2 Interfere current staff functions

The workload of nursing staff might be slightly increased as they have to spend

time on education and applying the innovation. However, this innovation is

simply to apply which won’t take too long and evaluation of pain score and

education can be done during regular shift routine assessment , therefore current

staff functions will not be interfered.

3.4.3 Administrative Support

The administrators are supportive to research and evidence-based protocol. The

hospital set up a forum which allows all nurses to share their opinions and

28

suggestions in order to improve existing protocol. Moreover, nurses are welcomed

to develop a new protocol through this forum. Besides, each year our O&T

department encourages nurses to share different ideas and present the research in

the joint O&T nursing forum. The O&T department also reviews or develops

protocol regularly to maintain the standard of advanced nursing practice.

Therefore, the administrators would welcome this innovation which benefit to

clients.

3.4.4 Consensus

A protocol will not be success if work alone, a certain degree of consensus has

to be made. In the patient’s perspective, this new intervention is a

non-pharmacological treatment that they are in favor of as low risk of side effects.

In the nurse’s point of view, they agree this evidence-based innovation and

appreciate this simple intervention won’t occupy too much time which interfere

the routine work.

In doctor’s perspective, they support this intervention as less consumption of

analgesic which can reduce the potential complications induced by side effects.

Physiotherapists also welcome this innovation as their workload will be decreased

and the progress of physical exercise will become smoothly.

29

Before establishing a new protocol, approval from administrators which

includes Chief of Service (COS), General Manager of Nursing (GMN),

Department Operation Manager (DOM), Nursing Consultant (NC) and Ward

Manager (WM) must be obtained. The protocol must be turned down without their

support. Therefore, the rationale, significance, effectiveness and advantages of

superficial heat therapy supported by evidence-based research should be

explained. In order to persuade them, the implementation potential of an

innovation proposal with budget plan must also be presented. It is importance to

allow time for them to ask and clarify any misunderstand.

Moreover, gaining support from orthopaedics medical officer is an essential

element of this protocol as the heat wrap therapy is initiated with Orthopaedics

medical officer’s prescription. Studies of Kettenmann (2007) and Nadler (2002)

showed that heat wrap therapy is superior to oral medications in pain relief and

patient tends to less use of oral analgesic when receiving heat wrap therapy.

Doctors can consider the effect of heat wrap therapy when prescribing analgesic.

Therefore, details and significant of protocol must be explained to them. They are

welcomed for raising their concerns and sharing opinions on developing protocol

in order to increase the compliance of patient to new intervention.

Nurses who are responsible to carry out the protocol are also another important

30

professionals towards success. Some nurses may reluctant to change or adopt the

new techniques, therefore the details and advantages of protocol must be

explained. The skills of applying this new innovation have also to be introduced.

3.4.5 Requirement of special skills and staff training

Heat wrap therapy is an evidence-based practice with new innovated

technology to nursing staff. The skills of applying heat wrap are required to

introduce to nursing staff. Therefore one-hour training workshop will be provided

with compensation hour and continuous nursing education point.

3.4.6 Availability of Essential equipment & facilities

The superficial heat therapy requires continuous low-level heat wrap which is

not available in the current setting. Therefore, an estimated amount of heat wrap

should be purchased. A store room is already available for storage of equipment

3.4.7 Availability of Evaluation tools

The outcome measurement is pain intensity and it is measured by Numeric

Rating Scale which is available in the pain score charting. The charting is

31

currently used in the ward setting.

3.5 Cost-Benefit Ratio

3.5.1 Potential Risk

There is no serious adverse effects occurred in using superficial heat therapy

during studies. Mild erythema is rarely noted but can be resolved without

intervention (Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002).

3.5.2 Potential Risk of maintaining current practice

Patients will request for more analgesic if the pain is not relieving. The risk of

side effects of analgesic, for example, peptide ulcer is increased (Drug Office,

2013a). Those complications will increase the duration of hospitalization and

prolong the bed resting time which delay the recovery and increase disability.

Undoubtedly, the quality of life of patients is reduced.

The medical cost will be increased due to the increased consumption of

medication and prolonged hospitalization.

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3.5.3 Potential Benefits

The superficial heat therapy can relieve low back pain effectively. Patient will

tend to less use of oral analgesic which lowers the risk of complication

development. Moreover, the sleep quality will be improved. Patient can start

rehabilitation exercise earlier and maintain quality of life. These benefits can

shorten the length of hospital stay and decrease medication use, thus reduce the

medical cost of the hospital. Besides, this evidence-based superficial heat therapy

can enhance the professionalism of nurses. Nurses can strengthen their confidence

to handle patients with low back pain.

3.5.4 Cost for implementation of protocol

3.5.4.1 Set up cost

Material cost

The superficial heat therapy requires heat wrap which cost 0.99US Dollars per

each. (Approximately $8 HK dollars) According to admission statistics record of

O&T department, there are estimated 600 patients per year fit for this intervention.

Each patient will use 2 packs of heat wrap for 2 consecutive days in this protocol.

An extra amount of 100 heat wrap also has to be ordered for replacement as there

33

are risks of broken or not functioning of heat wrap. Therefore, the total amount of

1300 heat wrap is required annually which costs $10400.

The printing of leaflets about heat wrap therapy for patient’s education cost

$0.2 per each. 600 printings are required which cost $120 in total.

The stationary and computer component used in the workshop are available

which is free of charge. Evaluation from is also available in the ward setting, no

extra cost will be charged.

The total amount of set up cost is $10,520. The detail of calculation is attached

in Appendix VI.

Non-material cost

There are two one-hour training workshops provided to all responsible nurses,

the venue and manpower are the non-material cost in this protocol. The venue for

holding the workshop is available and free of charge after getting the hospital’s

approval. Two RN trainers will be responsible for providing training to all nurses.

Compensate hour and continuous nursing education point will be offered to all

nurses who attended the workshop, as well as trainers. Therefore, no extra salary

costs will be charged.

34

3.5.4.2 Operational Cost

This protocol is implanted by nurse and the heat wrap can be applied during

routine work. Therefore, no extra operational salary has to be spent. Besides, a

store room is available for storage of heat wrap which is also free of charge.

3.5.5 Cost –benefit ratios

According to clinical observation, the average length of stay of patients with

low back pain is 7 days and the hospital stay cost for each day is around $4900.

Panadol is the common drug prescription for pain relief. However, most

patients request more pain killers for pain control on the next day. The common

regimen for additional analgesics includes oral tramadol and voltaren. Pepcidine

will also be prescribed at the same time for prophylactic use of peptic ulcer.

Follow up appointment will be given to patient which is 14 days after discharge in

average with medications prescribed.

The costs of maintaining current practice of each patient is $34331.2.

Patients would have better pain control and remains active when applying heat

wrap, therefore they can start rehabilitation exercise 2 days earlier instead of

taking bed rest for 2 days in current practice of physiotherapist. By clinical

35

experience, the earlier starting physical exercise, the less duration of

hospitalization. Therefore, it is believed that the estimated length of stay after

implementing heat therapy is 5 days. The unit cost of applying the intervention is

$24516.2. The details of calculation are in Appendix VII.

This heat wrap therapy can save $9815 per person and the annual cost saving is

($9815 x 600 patients/ year) = $5,889,000. The cost-benefit ratio is ($10,520 /

$5,889,000) = 0.0018.

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Chapter 4

Evidence-based Practice Protocol

4.1 Title

An evidence-based protocol of using superficial heat therapy for adult patients

with acute low back pain in reducing pain

4.2 Objectives

The objective of this evidence-based protocol is to relieve pain in adult patients

with acute low back pain by using continuous low-level heat wrap. Secondly, it

optimizes the pain management in a safe and cost-effective way. Thirdly, it

provides guidelines for nurses when applying superficial heat therapy.

4.3 Target User

All O&T nurses, including Registered Nurse (RN) and Enrolled Nurse (EN)

will be the target users of this guideline.

4.4 Target Population

The target population is adult patients admitted with acute low back pain. Those

eligible patients must be ambulatory and cognitive intact which can follow the

37

instructions and agree for the superficial heat therapy. Female patients are

required to have negative urine pregnancy test. Patients with any evidences or

history of radiculopathy, other neurologic deficit or spinal surgery must be

excluded in this protocol. Patients with hypersensitivity to heat or had any skin

lesions on the lumbar region are also excluded.

4.5 Rating system of Recommendations

The recommendations of this guideline are graded with consideration of level

of evidence by using SIGN grading System 1999-2012. (Appendix IV, V and

VIII)

4.6 Grades of Recommendations

4.6.1 Using Continuous low-level heat wrap as a mean to provide superficial

heat therapy.

Heat wrap is effective in reducing pain for treating low back pain (Kettenmann

et al., 2007; Tao & Bernacki, 2005; Mayer et al., 2005; Nadler et al., 2003a;

Nadler et al., 2003b; Nadler et al., 2002). It is a safe and non-pharmacological

device which approved as FDA class I medical device (Tao & Bernacki, 2007). It

delivers continuous low-level heat to the low back and allow patients to remain

38

mobility when wear (Mayer et al., 2005).

4.6.2 Wearing a Heat wrap for approximately 8 hours continuously in the

daytime.

Heat wrap provides constant heat at 40OC for at least 8 hours continuously (Tao

& Bernacki, 2005; Mayer et al., 2005; Nadler et al., 2003a; Nadler et al., 2003b;

Nadler et al., 2002). There is no serious adverse effect occurred and the risk of

minor adverse effects is much lower when using in the daytime (Kettenmann et al.,

2007; Tao & Bernacki, 2005; Mayer et al., 2005; Nadler et al., 2003a; Nadler et al.,

2002).

4.6.3 Applying heat wrap for 2 consecutive days.

The duration of applying heat wrap therapy ranged from 2 to 5 consecutive

days (Kettenmann et al., 2007; Tao & Bernacki, 2005; Mayer et al., 2005; Nadler

et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002). Using heat wrap for 2

consecutive days can exhibit significant pain relief with high level of evidence

(Nadler et al., 2002).

39

4.6.4 Routine assessment to evaluate effectiveness of heat wrap in pain

intensity for 4 consecutive days.

The heat wrap therapy has significant pain improvement in the first 4 days and

kept consistent afterwards (Kettenmann et al., 2007; Tao & Bernacki, 2005;

Mayer et al., 2005; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002).

Routine assessment allows nurses to examine the effectiveness which does not

increase their workload and prevents undesired adverse event.

4.6.5 Using Numeric Rating Scale to measure pain intensity for evaluation.

Pain intensity is a better indicator for showing the rate of change in pain (Tao &

Bernacki, 2005). Numeric Rating scale is a sensitive and reliable measurement for

pain. It is easier to use and available in current practice.

40

Chapter 5

Implementation Plan

After developing the evidence-based practice protocol, it comes to the

implementation. Before implementing the new intervention, we have to obtain

approval from the administrators. Besides, we have to explore and consider

solutions to any issues or problems that may arise during the implementation

process. Therefore, a thorough planning of communication with stakeholders and

the process of implementation is important and will be discussed in this chapter

5.1 Communication Plan

5.1.1 Identifying Stakeholders

Stakeholders are people who are interested in the program, have impact on the

implementation or affected by the proposed changes of the new interventions.

Initially, stakeholders should be identified and prioritized for interviews. The

stakeholders in this program include:

1. Administrators who are the decision maker: Ward Managers, Nurse

Consultant of Orthopaedics and Traumatology (O&T) (NC), Department

Operating Manager of O&T (DOM), Chief of Service of O&T (COS),

41

General Manager Nursing (GMN), Cluster Chief Executive (CCE)

2. Frontline Nurses who are the target users of the protocol: Nursing

Officer(NO), Advanced Practice Nurse (APN), Registered Nurse(RN),

Enrolled Nurse(EN)

3. Orthopaedics Doctors who are the supporter of the protocol by giving

prescription of the heat wrap therapy: Consultants, Assistant Consultants

(AC), Medical Officer (MO)

4. Physiotherapist who can be benefited from the intervention as their

workload will be reduced if the protocol worked out

5. Patients who can be benefited from the intervention

5.1.2 Forming Program Team

The program proposer cannot proceed the protocol alone. It is crucial to gain

support from others and form a team in order to facilitate communications.

The program team will involve 1 APN and 3RNs corresponding to different

targeted acute wards. A meeting will be held to introduce the current situation and

practice to treat low back pain, the affirming needs of developing new

interventions and details of heat wrap therapy supported by research finding.

Moreover, we will review the evidence-based protocol by discussing the

42

implementation potential and making compromise according to different ward

practice and the comments received from ward staff. Eventually, a program team

including 1 APN as the team advocator, 4 RNs including myself as team

coordinators, and a program proposer will be formed.

5.1.3 Process of Communication Plan

The process of communication can be divided into 3 phases which are initiation,

guiding and sustaining stages.

5.1.3.1 Initiation Stage

5.1.3.1.1 Communication plan with Ward Managers

The target setting of the intervention is 4 acute O&T wards. It is important to

obtain an approval from the ward managers first. Four RN team coordinators

should invite their respective ward managers for meetings. The APN team

advocator will be responsible for administration tasks such as reserving the

meeting venue, sending invitations and proposal to the concerned ward managers.

During the meeting, throughout materials should be presented, objectives be

explained and questions be answered. Details of the new intervention with

research support, the needs of change, the benefits of the new method, the

43

transferability and feasibility of the evidence-based protocol with budget plan.

The ward managers will share their ward situation and offer advices. The proposal

and guideline will then be revised and redistributed for approval. The APN team

advocator will then approach NC, DOM, Consultants and COS with the revised

proposal and seek their approval for presenting the new interventions during the

department meeting.

5.1.3.1.2 Communication plan with NC, DOM, Consultants and COS

The team advocator and the proposer will present the new, evidence-based

intervention at the department meeting. Every participant should receive a hard

copy of the proposal. The proposer will present data such as the admission rate of

low back pain by using figures and charts, the current treatment and the new

interventions with research support. The implementation potential, the benefits

and budget plan should also be explained in details. Furthermore, the proposer

will present the revised protocol and follow-up plans such as training workshop

for frontline nurses in applying the new intervention. The department meeting

should conclude with a sharing session for collecting comments and advice.

If this evidence-based protocol is endorsed, it will be sent to GMN and CCE by

DOM for seeking final approval and funding.

44

5.1.3.1.3 Communication plan with GMN and CCE

Although DOM has the responsibility of presenting the proposal to GMN and

CCE, the proposer has to take the initiative to present revised details of the new

intervention at the department conference. Meanwhile, the program team should

provide the necessary support and strategize solutions to any problems arise

throughout the process of communications.

5.1.3.1.4 Communication plan with Frontline Nurses and Physiotherapist

After obtaining all the required approval, it is essential to announce the

guidelines to frontline nurses and physiotherapist before implanting the pilot study.

A luncheon talks will be held in the theatre with compensation hours for

attendants. Poster of invitation will be displayed on the notice board in all acute

O&T wards as promotion. The vision, relevant details, benefits of the new

intervention and flow of protocol will be introduced during the session. A Q&A

sessions would be held for clarifying any misunderstanding and collecting

opinions.

5.1.3.1.5 Communication plan with Patients

The contents of heat wrap therapy and its benefit will be printed on leaflets

which would be placed on the information shelf for patients’ information. Nurse

staff should deliver and explain the contents of the leaflets before applying heat

45

wrap therapy.

5.1.3.2 Guiding Stage

The evidence-based protocol will be printed and distributed to targeted acute

ward setting. The protocol will also be uploaded to the department website for

referencing and a forum will be set up for opinions, information exchange and

answering any queries.

There are total 80 nurses responsible for executing the new interventions. Two

1-hour training workshops will be delievered. Each workshop will be held by 2

RN team coordinators including the proposer. Each nurse has to attend either

session. The training workshop will explain the contents of the protocol, the time

of measurement and its method. Moreover, the session will demonstrate the

method of using heat wrap therapy and re-demonstration session.

Four RN team coordinators are responsible for providing support or dealing

with any difficulties related to heat therapy faced by frontline nurses,

physiotherapist, as well as patients.

5.1.3.3 Sustaining Stage

Four RN team coordinators have to monitor any misfiling of patient’s charting,

46

for example pain scale chart and discharge date in admission statistical record, in

order to prevent missing data. They also have to monitor any adverse events

induced by heat therapy by collecting staff reporting or documentation. They are

responsible for encouraging frontline nursing staff to apply this heat therapy by

appreciation and giving positive reinforcement with evidence of patient’s

progress.

The proposer is responsible for monitoring the quantity of heat wrap to ensure

there is enough supply during the pilot test and estimating the demands in the

future. The team advocator has to collect feedback from ward managers, doctors

and physiotherapist. Regular meetings will be held by the program team

bi-weekly to follow up the progress and revise the protocol. Those meeting

minutes will be reported to DOM. The time frame of implementation plan is

attached in Appendix IX.

5.2 Pilot Study

Pilot Study plays an important role in implementing a new intervention. It is

used to test the feasibility of the intervention which intended to use in a larger

scale in the future. It helps in evaluating any modifications needed in the future

planning. (Leon, Davis & Kraemer, 2011)

47

5.2.1 Study Design

A Quasi-experimental design will be used in the pilot study.

5.2.2 Objectives

The objectives of the pilot study are:

1. Testing the feasibility of the superficial heat therapy guidelines

2. Assessing nurses’ attitude to new guidelines

3. Assessing patient’s satisfaction to the new interventions

4. Identifying any unpredictable problems or obstacles

5.2.3 Target Population and Program Intervention

The Superficial heat wrap therapy protocol will be executed in 4 acute O&T

wards, including 2 male and 2 female wards, within a public hospital.

Adult patients admitted with acute low back pain, ambulatory and cognitive

intact which are able to follow the instructions of using heat wrap therapy will be

recruited to the program. For female patients, only those with negative urine

pregnancy test will be recruited.

48

Patients with hypersensitivity to heat, evidence or history of neurologic deficit,

radiculopathy or spinal surgery, any skin lesions over lumbar region must be

excluded to the program.

The operational flow of superficial heat wrap therapy is attached in Appendix

X.

Sixteen eligible patients from 4 target ward settings will be recruited to the pilot

study. Considering the admission statistical record, the duration of pilot study will

be set at 1 month.

5.2.4 Outcomes Measurements

The following outcomes will be measured and evaluated, which are:

1. Pain intensity

2. Sleep quality

3. Nurse’s satisfaction level

4. Patient’s satisfaction level

5. Length of Hospital Stays

49

5.2.5 Evaluation of the guideline

After the pilot test, the program team will hold an evaluation meeting to discuss

the results of outcomes and feedback from various disciplines. The program team

will revise the protocol and offer suggestions. The revised protocol will then be

presented to ward managers and DOM during department meeting and final

decision will be announced by DOM.

Besides, the program team will evaluate the effectiveness of the measuring

tools and the feasibility of the measuring time. Although the risk of adverse effect

of heat wrap such as blister and erythema is low, an emergency plan has to be set

up including actions such as removing heat wrap immediately, soothing with cold

water and assessing by doctor for medication prescription if necessary.

50

Chapter 6

Evaluation Plan

An evaluation plan helps to clarify the measureable outcomes of program in

order to determine effectiveness of the program by the evaluation results.

Outcomes are identified from 3 different perspectives include patient, health care

provider and the health care system. The method and the timeframe for outcome

measurements are also to be decided. Furthermore the nature and number of

clients are determined. The data collected are analyzed with specified methods

and the basis of considering the effectiveness of program is compromised.

6.1 Identifying Outcomes and Outcomes Measurements

The outcomes of the protocol can be divided into 3 aspects: patient, healthcare

provider and the health care system.

6.1.1 Patient outcomes

The aim of the superficial heat wrap therapy protocol is to reduce acute low

back pain among adult patient which is supported by the 7 evidence-based studies.

(Kettenmann et al., 2007; Mayer et al., 2005; Tao & Bernacki, 2005; Nuhr et al.,

2004; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al., 2002) Therefore, the

51

primary outcome is pain intensity. Pain intensity will be measured by using the

0-10 Numeric Rating Scale in currently used pain chart which is attached in

Appendix XI.

Secondary outcome is the sleep quality. Although there is insufficient research

proved that heat therapy helps in improving sleep quality, (Tao & Bernacki, 2005;

Nadler et al., 2003b), this program determines to examine its effectiveness on

sleeping. Sleep quality will be assessed with the 6-point Verbal Rating Scale in

response to a question “How well did you sleep last night?” ; ranging from 0=

very poor to 5 = excellent (Nadler et al., 2003b).

Patient’s satisfaction is another secondary outcome and it will be reflected by

satisfaction level to the protocol. Satisfaction level will be assessed by using the

5-point Verbal rating scale ranging from” Not at all satisfied” from “Very

satisfied”. Comments from patients will also be evaluated if provided.

Both sleep quality and patient’s satisfaction level will be charted in a specific

assessment form which comprised by the program team. The assessment from is

attached in Appendix XII

6.1.2 Healthcare Provider Outcomes

Nurse’s satisfaction level will be assessed by ranking few statements in a

52

questionnaire ranging from “strongly disagree” to “strongly agree”. Those

questions can reflect their attitude towards the protocol. The questionnaire will be

set up by the program team and approved by DOM. The nurses’ evaluation

questionnaire is attached in Appendix XIII.

6.1.3 System Outcomes

Length of hospital stays will be evaluated by tracing the admission statistical

record at the end of the program. The reduction in the length of hospital stays

helps to prove the cost-effectiveness of the program.

6.2 Determining Nature and Number of Clients

6.2.1. Nature of Clients

According to the result of pilot study, there is no modification of requirement of

target population. The nature of clients is the same as those in the pilot study

which was mentioned in Chapter 5.

6.2.2 Sampling Method

Non-probability purposive sampling will be used in this program. Patients who

53

meet the inclusion criteria of the protocol are recruited.

6.2.3 Sample Size

The sample size is calculated by G*Power 3.1.9.2. In order to estimate sample

size, p-value, power, mean difference and standard deviation are adapted from

relevant studies (Kettenmann et al., 2007; Mayer et al., 2005; Tao & Bernacki,

2005; Nuhr et al., 2004; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al.,

2002).

Eventually, 41 participants are required for the program with medium effect

size (d=0.5) at the p≤0.05 level of significance with a power of 90% and attrition

rate of 10% in a one tailed test. The detail of calculation is attached in Appendix

XIV.

This program are used by all nurses, therefore the calculation of sample size of

nurses are not needed.

6.2.4 Duration of Program

According to the admission statistical record, the program will be carried out

for 2 months in order to collect sufficient data.

54

6.3 Data Collection and Method of Analysis

6.3.1 Data Analysis Designs

An intention-to-treat analysis was conducted among all subjects with any

efficacy data.

6.3.2 Time for Outcome Measurements

Pain intensity measurement is a daily routine. Pain intensity will be measured at

pre-intervention (Day 0) and 4 days post-intervention(Day 1-4). Sleep Quality

will be measured daily from Day 0 to Day 4. Patient’s satisfaction will be asked

on Day 4. Questionnaire for evaluating nurses’ satisfaction will be carried out

after the program. Length of Hospital stays of each patient will be traced at the

end of the program.

6.3.3 Method of Analysis

Statistical analytical software IBM SPSS Statistics 22.0 will be used for data

analysis. Patient’s demographic data will be presented by using descriptive

statistical method. The pain intensity and sleep quality will be tested by using 1

55

tailed paired t-test at the p≤0.05 significance level. Patient satisfaction and nurse

satisfaction will be analyzed by using descriptive statistical method. The mean of

length of hospitals stays will be calculated and compared with previous years.

6.4 Basis for an effective change of practice

The program of superficial heat therapy will be considered as successful if the

followings are achieved. Those achievements are based on relevant

evidence-based research studies and compromised by program team.

1. Pain intensity is reduced by over 3 points (Tao & Bernacki, 2005)

2. The mean of Sleep quality is scored at 3 or above (Nadler et al., 2003b)

3. 90% of nurses satisfied with the superficial heat protocol.

4. 80% of patients satisfied with the superficial heat protocol.

5. The mean of length of hospital stays is reduced by 2 days or more

56

Chapter 7

Conclusion

According to the reviewed studies, superficial heat therapy is proved as an

effective intervention in reducing pain among adult patients with acute low back

pain. Continuous low-level heat-wrap therapy is suggested as a safe,

non-pharmacological and cost-effective measure. Patients wearing heat-wrap

experienced better pain control than taking analgesic. Moreover, patients can

remain active to carry out physical exercise, daily living and maintain their quality

of life. However, heat wrap therapy is not a common practice in local public

hospital settings. In this regards, this translational nursing research is conducted to

develop an evidence-based guideline for nurses to provide high quality of care to

patients with acute low back pain.

The guidelines are based on the relevant data extracted from high quality of

research studies which critically appraised by Scottish Intercollegiate Guidelines

Network. The results suggested that the application of heat wrap therapy for 8

hours for 2 consecutive days in daytime is the most effective method in pain

reliefing among adult patients with acute low back pain.

After considering the implantation potential of the protocol, it is transferrable

57

and feasible to the proposed ward setting with clearly inclusion and exclusion

criteria. A plan of implantation and evaluation is also discussed in this paper for

implementing and evaluating the effectiveness of the guidelines. The newly

developed superficial heat therapy guidelines are beneficial to adult patients with

acute low back pain, by reducing their pain and reserving their quality of life, as

well as relieving the medical burden.

Sleep disturbance and insomnia are common associated problems of low back

pain. There is little evidence proved that heat wrap therapy improves quality of

sleep. Further studies investigating the effect of heat wrap therapy on sleep quality

is encouraged. Moreover, there is lacks of evidence-based research studies about

Superficial Heat Therapy to acute low back pain patients in Hong Kong. Further

investigations are encouraged as people gradually prefer non-pharmacological

approach which may become a new evolution towards current health care system.

58

Appendix I: History of Searching Studies

Date of search: 18/6/2013 Database searched

Pubmed CINAHL via

EBSCOHOST

British

Nursing

Index via

Proquest

Search Terms

Low back pain or

Back pain or

Acute low back pain

44683 8174 609

Superficial heat therapy or Heat therapy or

Hot therapy or Thermotherapy or

Heat treatment or Heat management or

Heat or Hot or Heat pack or Hot pack or

Heat pads or Hot pads or Heat wrap or

Heatwrap or Continuous thermotherapy or

Continuous heat therapy or

Continuous hot therapy or Warm or

Warming

300705 23661 542

Pain or

pain management or

pain measurement or

pain intensity or

pain scale

536773 80062 8011

AND 673 106 10

Limit to year 2002 - 2013 414 89 6

Limit to RCT 92 26 1

Screened by title or abstract 13 2 0

Screened by full text 7 0 0

59

Appendix II: Table of Evidence

Bibliography

citation

Study

design

Evidence

Level

Number of patients Subject characteristic Intervention(s) Comparison Outcome measure(s) Length of

follow up

Effect size

Kettenmann et

al., 2007

RCT 1- Total = 30

(8 drop out, rate =

21%)

Control Group: 15

Treatment Group:

15

-Age: 18-80

- A mix of Acute and

Sub-acute low back

Control Group:

- Female: 12

- Male: 3

- Mean Age (SD):

57.9 (11.7)

Treatment Group:

- Female: 8

- Male: 7

- Mean Age (SD):

56.2 (14.9)

Oral Analgesic

(use only if

needed) +

heatwrap

therapy (4 hours

per day for 4

consecutive

days)

Oral

Analgesics

(use only if

needed)

Subjective

Parameters

Pain intensity

(0-100mm Visual

Analog Scale)

Day 1-5 On day 3:

30 vs 58 (p =0.02)

On day 4:

28 vs 48 (p=0.042)

60

Bibliography

citation

Study

design

Evidence

Level

Number of patients Subject characteristic Intervention(s) Comparison Outcome measure(s) Length of

follow up

Effect size

Tao X. &

Bernacki, E.J.,

2005

RCT 1+ Total = 43

Control Group: 18

Treatment Group:

25

-Age: 20-62

-A mix of Acute and

Sub-acute low back

Control Group:

- Female: 15

- Male: 3

- Average Age: 35

Treatment Group:

- Female:21

- Male: 4

- Average Age: 36.2

Education +

Heat Wrap ( 8

hours per day

for 3

consecutive

days)

Education Primary Outcome:

1. Pain Intensity (0 -10

Numeric Rating

Scale)

2. Pain Relief (6-point

Verbal Rating

Scale)

Day 1-3

Day 4,

Day 7,

Day 14

1.

Day Difference

(95%CI)

p-

value

1 -1.73 (-2.83,-0.65) 0.0029

2 -1.43 (-2.70,-0.16) 0.0293

3 -2.33 (-3.73,-0.94) 0.0019

4 -1.78 (-3.31,-0.26) 0.0237

7 -1.69 (-3.18, -0.21) 0.0257

14 -1.75 (-3.33, -0.18) 0.0305

2.

Day Difference

(95%CI)

p-

value

1 1.55 (0.58,2.52) 0.0027

2 0.73 (-0.05,1.51) 0.0631

3 1.40 (0.54,2.25) 0.0022

4 1.13 (0.11,2.14) 0.0299

7 0.63 (-0.47.1.72) 0.2491

14 0.80 (-0.33,1.93) 0.1567

61

Bibliography

citation

Study

design

Evidence

Level

Number of patients Subject characteristic Intervention(s) Comparison Outcome measure(s) Length of

follow up

Effect size

Mayer et al.,

2005

RCT 1+ Total: 100

(Dropped:8, rate:

8%)

Heat Wrap Group: 25

(Completed: 22

Dropped: 3)

Exercise Group: 25

(Completed: 24

Dropped: 1)

Heat + Exercise

Group: 24

(Completed: 21

Dropped: 3)

Control Group: 26

(Completed: 25

Dropped: 1)

-Age: 18-55

- A mix of Acute and

Sub-acute low back

Heat Wrap Group:

Female: 17 Male: 8

Age (SD): 29.3 (9.9)

Exercise Group:

Female: 15 Male: 10

Age (SD): 32.6 (10.3)

Heat + Exercise

Group:

Female: 15 Male: 9

Age (SD): 31.8 (11.8)

Control Group

Female: 24 Male: 2

Age (SD): 31.2 (10.9)

Heat Wrap

Group: Heat

Wrap for 8 hours

per day for 5

consecutive days

Exercise Group:

Directional

Preference-based

exercise once

every hour while

awake for 5

consecutive days

Heat + Exercise

Group:

Heat wrap for 8

hours per day and

exercise once

every hour while

awake for 5

consecutive days

Educational

Booklet

Secondary Outcome:

Pain Relief

(6-point Verbal Rating

Scale)

Day 2

Day 4

Day 7

Day 2:

No significant difference (p=0.111)

Day 4:

Heat wrap vs Education

1.9 vs 0.8 (p=0.026)

Pain relief score difference: 1.1

Heat + Exercise vs Education.

2.5vs 0.8 (p=0.000)

Pain relief score difference: 1.7

Day 7:

Heat + Exercise vs Exercise

3.2 vs 2 (p=0.007)

Pain relief score difference: 1.2

Heat + Exercise vs Education

3.3 vs 1.3 (p<0.001)

Pain relief score difference: 2

Incidience of pain relief:

Heat + Exercise vs Education

95.2% vs 40% (p=0.003; odds

ratio=29.85)

62

Bibliography

citation

Study

design

Evidence

Level

Number of patients Subject characteristic Intervention(s) Comparison Outcome measure(s) Length of

follow up

Effect size

Nuhr et al.,

2004

RCT 1+ Total: 90

(10 drop out, rate =

9%)

Active warming

group : 47

Passive warming

group: 43

-Age >19 years old

- Acute low back pain

Active warming group:

Female: 21

Male : 26

Age (SD) : 36.8 (8.2)

Passive Warming group:

Female: 12

Male: 31

Age (SD) : 41.7 (12)

Heating blanket

with 42 oC

Woolen

blanket

Pain Intensity

(0-100mm Visual

Analog Scale)

--- Active Warming group:

74.2 (95% CI, 71.7-76.7) to

41.9 (95% CI, 36.5-47.5)

(p<0.01)

Passive warming group:

73.3 (95% CI, 69.7-76.9) to

74.1 (95% CI, 70.4-77.8)

Pain score mean difference:

-32.3 vs +0.8

63

Bibliography

citation

Study

design

Evidence

Level

Number of

patients

Subject characteristic Intervention(s) Comparison Outcome measure(s) Length of

follow up

Effect size

Nadler et al.,

2003a

RCT 1+ Total: 219

(Dropped: 24,

Rate :10.9)

Heat wrap group:

95

(Completed: 92

Dropped: 3)

Oral Placebo: 96

(Completed: 88

Dropped: 8)

(For Blinding)

Oral Ibuprofen: 12

(For Blinding)

Unheated Wrap:

16

(Completed:15

Dropped: 1)

-Age: 18-55

- A mix of Acute and

Sub-acute Low Back

Pain

Heat wrap group:

Age (SD): 35.55 (11.57)

Oral Placebo:

Age (SD): 36.73 (10.82)

Oral Ibuprofen:

Age (SD): 36.25 (11.56)

Unheated Wrap:

Age (SD): 34.88 (11.32

Heat wrap for 8

hours per day for 3

consecutive days

Oral Placebo

-2 tablets for 3 times

per day with 6 hour

apart for 3

consecutive days

Oral Ibuprofen

- 2oomg x 2 tablets

for 3 times per day

with 6 hour apart for

3 consecutive days

Unheated wrap

8 hours per day for 3

consecutive days

Primary Outcome:

Pain relief

(6-point Verbal Rating

Scale)

Day 1-5 On Day 1:

1.76 +/- 0.10 vs 1.05 +/- 0.11 (p<0.001)

Pain relief score difference:

0.61

Incidence of complete pain relief over

1-5 days:

15.4% vs 6.6% (p=0.04; odd ratio =

2.89)

On days 4 and 5:

2.5 +/- 0.16 vs 1.56 +/- 0.18 (p<0.0001)

Pain relief score difference:

0.94

64

Bibliography

citation

Study

design

Evidence

Level

Number of patients Subject characteristic Intervention(s) Comparison Outcome

measure(s)

Length of

follow up

Effect size

Nadler et al.,

2003b

RCT 1+ Total: 76

(Dropped: 6,

Rate :7.8%)

Heat wrap group: 33

(Completed: 31

Dropped: 2)

Oral Placebo: 34

(Completed: 32

Dropped: 2)

(For Blinding)

Oral Ibuprofen: 4

(For Blinding)

Unheated Wrap: 5

(Completed:3

Dropped: 2)

-Age: 18-55

-A mix of Acute and

Sub-acute Low Back Pain

Heat wrap group:

Female: 21 Male: 12

Age (SD): 42.21 (9.38)

Oral Placebo:

Female: 21 Male:13

Age (SD): 41.53 (9.76)

Oral Ibuprofen:

Female:3 Male: 1

Age (SD): 42.5 (2.65)

Unheated Wrap:

Female: 4 Male: 1

Age (SD): 34 (8.37)

Heat wrap for 8

hours during

sleep for 3

consecutive

nights

Oral Placebo

-2 tablets 15-20mins before

sleep for 3 consecutive nights

Oral Ibuprofen

- 2oomg x 2 tablets

15-20mins before sleep for 3

consecutive nights

Unheated wrap

8 hours during sleep for 3

consecutive nights

Primary Outcome:

1) Morning Pain

relief

(6-point Verbal

Rating Scale)

Secondary Outcome:

2) Mean Daytime

Pain relief

(6-point Verbal

Rating Scale)

3) Mean extended

Pain relief

(6-point Verbal

Rating Scale)

Day 2-5 1) 2.75 +/- 0.25 vs 1.45 +/- 0.23

(p<0.00005)

Pain relief score difference:

0.7

2) 2.69 +/- 0.24 vs 1.46 +/- 0.23

(p<0.00005)

Pain relief score difference:

1.23

3) 2.90 +/- 0.29 vs 1.60 +/- 0.27

(p<0.0001)

Pain relief score difference:

1.3

65

Bibliography

citation

Study

design

Evidence

Level

Number of patients Subject characteristic Intervention(s) Comparison Outcome

measure(s)

Length of

follow up

Effect size

Nadler et al.,

2002

RCT 1+ Total: 371

(Dropped: 8,

Rate :2.16%)

Heat wrap group: 113

(Completed: 111

Dropped: 2)

Acetaminophen: 113

(Completed: 111

Dropped: 2)

Ibuprofen: 106

(Completed: 102

Dropped: 4)

(For Blinding)

Oral Placebo :20

(For Blinding)

Unheated Wrap: 19

-Age: 18-55

- A mix of Acute and

Sub-acute Low Back Pain

Heat wrap group:

Female: 66 Male: 47

Age (SD): 35.82 (10.54)

Oral Acetaminophen:

Female: 64 Male: 49

Age (SD): 34.9 (11.29)

Oral Ibuprofen:

Female: 63 Male: 43

Age (SD): 36.61 (10.4)

Oral Placebo:

Female: 12 Male: 8

Age (SD): 38.00 (9.07)

Unheated Wrap:

Female: 11 Male: 8

Age (SD): 36.79 (9.32)

Heat wrap for 8

hours per day for 2

consecutive days

Acetaminophen

- 2 tablets for 4 times

per day for a total dose

of 4000mg for 2

consecutive days

Ibuprofen

- 200 mg x 2 tablets for

3 times per day for total

dose of 1200mg + 2

tablets placebo for 1

time per day for

blinding for 2

consecutive days

Oral Placebo

- 2 tablets for 4 times

per day for 2

consecutive days

Unheated wrap

8 hours per day for 2

consecutive days

Primary Outcome:

Pain relief

(6-point Verbal

Rating Scale)

Day 1-4 Heat vs Acetaminophen vs

ibuprofen

On Day 1:

2 vs 1.32 (p=0.0001) vs 1.51

(p=0,0007)

Pain relief score difference:

0.68 and 0.49

On Day 2:

2.78 vs 2 (p=0.0001) vs 2.06

(p=0.0001)

Pain relief score difference:

0.78 and 0.72

Day 3-4:

2.61 vs 1.95 (p=0.0009) vs 1.68

(p=0.0001)

Pain relief score difference:

0.66 and 0.93

66

Appendix III: Methodology Checklists

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Kettenmann B., Wille C., Lurie-Luke E., Walter D. & Kobal G. (2007). Impact of Continuous Low

Level Heatwrap Therapy in Acute Low Back Pain Patients: Subjective and Objective

Measurements. Clin J Pain, 23(8), 663-668. doi: 10.1097/AJP.0b013e31813543ef

Guideline topic: Superficial Heat Therapy in pain relieving

for patients with low back pain

Key Question No:

N/A

Reviewer:

LAI TSZ NING

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study� Does this study do it?

1.1 The study addresses an appropriate and clearly focused question

Yes ����

Can’t say �

No �

1.2 The assignment of subjects to treatment groups is randomised

Yes �

No �

Can’t say ����

Reported but method

not described

1.3 An adequate concealment method is used

Yes �

Can’t say �

No ����

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes �

Can’t say �

No ����

1.5 The treatment and control groups are similar at the start of the trial. Yes �

Can’t say

����

No �

1.6 The only difference between groups is the treatment under

investigation.

Yes ����

Can’t say �

No �

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes ����

Can’t say �

No �

67

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

21%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes � � � � No �

Can’t say � Does not

apply �

Per protocol Analysis

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes �

Can’t say �

No �

Does

not

apply ����

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows.

High quality (++)�

Acceptable (+)����

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes.

Sex distribution was not even between

groups. Greater number of female in

control group

Small sample size with about 20% drop

out rate

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of

the study, and the extent to which it answers your question and mention any areas of

uncertainty raised above.

Heatwrap Therapy was effective in reducing pain and better night’s sleep. No significant

difference in use of oral analgesics but a trend toward less use in heatwrap group.

68

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Tao X. & Bernacki E.J. (2005). A Randomized Clinical Trial of Continuous Low-level Heat

Therapy for Acute Muscular Low Back Pain in the Workplace. J Occup Environ Med, 47(12),

1298-1306. doi: 10.1097/01.jom.0000184877.01691.a3

Guideline topic: Superficial Heat Therapy in pain relieving

for patients with low back pain

Key Question No:

N/A

Reviewer:

LAI TSZ NING

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study� Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes ����

Can’t say �

No �

1.2 The assignment of subjects to treatment groups is randomised.

Yes �

No �

Can’t say ����

Reported but method

not described

1.3 An adequate concealment method is used.

Yes �

Can’t say �

No ����

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes ����

Can’t say �

No �

1.5 The treatment and control groups are similar at the start of the trial. Yes ����

Can’t say �

No �

1.6 The only difference between groups is the treatment under

investigation.

Yes ����

Can’t say �

No �

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes ����

Can’t say �

No �

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

0 %

69

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes ����

Can’t say �

No �

Does not

apply �

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes �

Can’t say �

No �

Does

not

apply ����

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)����

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes.

Risk of Bias: Single Blinding

(Participants)

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of

the study, and the extent to which it answers your question and mention any areas of

uncertainty raised above.

Heat wrap therapy had significantly reduced pain intensity from day 1 to day 14. Heat

wrap therapy had increased pain relief from day 1 to day 4. Although no significant

difference on day 7 and day 14 on pain relief, it is less useful as the pain intensity was

reduced dramatically at the beginning to a low level and kept consistent afterwards.

70

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Mayer J. M., Raplh L., Look M., Erasala G. N., Verna J. L., Matheson L. N. & Mooney V. (2005).

Treating acute low back pain with continuous low-level heat wrap therapy and/or exercise: a

randomized controlled trial. The Spine Journal, 5(4), 395-403. doi:10.11016/j.spinee.2005.03.009

Guideline topic: Superficial Heat Therapy in pain relieving

for patients with low back pain

Key Question No:

N/A

Reviewer:

LAI TSZ NING

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study� Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes ����

Can’t say �

No �

1.2 The assignment of subjects to treatment groups is randomised.

Yes � � � � No �

Can’t say �

Computer-generated

sheet

1.3 An adequate concealment method is used.

Yes �

Can’t say �

No ����

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes �

Can’t say �

No ����

1.5 The treatment and control groups are similar at the start of the trial. Yes �

Can’t say ����

No �

1.6 The only difference between groups is the treatment under

investigation.

Yes ����

Can’t say �

No �

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes ����

Can’t say �

No �

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

Total: 8%

Heat Wrap : 12%

Exercise: 4%

Heat + Exercise: 12.5%

Control: 3.8 %

71

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes ����

Can’t say �

No �

Does not

apply �

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes ����

Can’t say �

No �

Does not

apply �

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)����

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes.

Risk of Bias: No Blinding, Gender

imbalance in control group but similar

gender characteristics

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of

the study, and the extent to which it answers your question and mention any areas of

uncertainty raised above.

No significance difference at day 2. Heat wrap was significantly greater than education in

pain relief at day 4. Heat wrap plus exercise was greater than exercise or education at

day 7 with significant difference

72

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Nuhr M., Hoerauf K., Bertalanffy A., Bertalanffy P., Frickey N., Gore C., Gustorff B. & Kober A.

(2004). Active warming During Emergency Transport Relieves Acute Low Back Pain. Spine,

29(14), 1499-1503. Retrieved from

http://ovidsp.tx.ovid.com.eproxy1.lib.hku.hk/sp-3.8.1a/ovidweb.cgi?T=JS&PAGE=fulltext&D

=ovft&AN=00007632-200407150-00002&NEWS=N&CSC=Y&CHANNEL=PubMed

Guideline topic: Superficial Heat Therapy in pain relieving

for patients with low back pain

Key Question No:

N/A

Reviewer:

LAI TSZ NING

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study� Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes ����

Can’t say �

No �

1.2 The assignment of subjects to treatment groups is randomised.

Yes � � � � No �

Can’t say �

Computer-generated

codes

1.3 An adequate concealment method is used.

Yes � � � � No �

Can’t say �

Opaque Envelope

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes ����

Can’t say �

No �

1.5 The treatment and control groups are similar at the start of the trial. Yes ����

Can’t say �

No �

1.6 The only difference between groups is the treatment under

investigation.

Yes ����

Can’t say �

No �

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes � � � � No �

Can’t say �

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

Total: 9%

Active warming: 6%

73

completed? Passive warming: 14%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes � � � � No �

Can’t say � Does not

apply �

Per protocol analysis

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes �

Can’t say �

No �

Does

not

apply ����

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)����

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes.

Single blind: investigator

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of

the study, and the extent to which it answers your question and mention any areas of

uncertainty raised above.

Active Warming provide better pain relief and reduce anxiety than passive warming

during rescue transport

74

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Nadler S. F., Steiner D. J., Abeln S. B., Erasala G. N., Hengehold D. A. & Weingand K.W. (2003a).

Continuous low-level heatwrap therapy for treating acute nonspecific low back pain. Arch

Phys Med Rehabil, 84(3), 329-334. doi: 10.1053/apmr.2003.50102

Guideline topic: Superficial Heat Therapy in pain relieving

for patients with low back pain

Key Question No:

N/A

Reviewer:

LAI TSZ NING

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the

study design algorithm available from SIGN and make sure you have the correct checklist. If it is

a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be

rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention

Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason � (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study� Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes ����

Can’t say �

No �

1.2 The assignment of subjects to treatment groups is randomised.

Yes �

No �

Can’t say ����

Reported but method

not described

1.3 An adequate concealment method is used.

Yes �

Can’t say �

No ����

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes ����

Can’t say �

No �

75

1.5 The treatment and control groups are similar at the start of the trial. Yes �

Can’t say ����

No �

1.6 The only difference between groups is the treatment under

investigation.

Yes ����

Can’t say �

No �

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes ����

Can’t say �

No �

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

Total: 10.9%

Heat wrap :3.15%

Oral Placebo: 8.3%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes ����

Can’t say �

No �

Does not

apply �

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes �

Can’t say ����

No �

Does not

apply �

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)����

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes.

Single blind: investigator

No gender described among groups

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of

the study, and the extent to which it answers your question and mention any areas of

uncertainty raised above.

1. No serious adverse events occurred. 1 subject in heat wrap group was found

progressed to definite redness on day 5 which resolved without treatment.

2. Pain relief over Day 1-5 was significantly greater for the heat wrap compared with

placebo

76

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Nadler S. F., Steiner D. J., Petty S. R., Erasala G. N., Hengehold D. A. & Weingand K.W. (2003b). Overnight

Use of Continuous Low-level Heatwrap Therapy for Relief of Low Back Pain. Arch Phys Med Rehabil,

84(3), 335-342. doi: 10.1053/apmr.2003.50103

Guideline topic: Superficial Heat Therapy in pain relieving

for patients with low back pain

Key Question No:

N/A

Reviewer:

LAI TSZ NING

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study� Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes ����

Can’t say �

No �

1.2 The assignment of subjects to treatment groups is randomised.

Yes �

No �

Can’t say ����

Reported but method

not described

1.3 An adequate concealment method is used.

Yes �

Can’t say �

No ����

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes ����

Can’t say �

No �

1.5 The treatment and control groups are similar at the start of the trial. Yes ����

Can’t say �

No �

1.6 The only difference between groups is the treatment under

investigation.

Yes ����

Can’t say �

No �

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes ����

Can’t say �

No �

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

Total: 7.8%

Heat wrap :6%

77

Oral Placebo: 5.8%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes ����

Can’t say �

No �

Does not

apply �

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes ����

Can’t say �

No �

Does not

apply �

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)����

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes.

Single blind: investigator

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of

the study, and the extent to which it answers your question and mention any areas of

uncertainty raised above.

1. Mild erythema without blister formation was noted in 4 subjects who wore the heat

wrap but resolved without intervention

2. The heat wrap group had significantly greater pain relief after 3 nights of treatment

compared with placebo and had extended pain relief 8 hours after waking and on day 4

and 5.

78

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Nadler S. F., Steiner D. J., Erasala G. N., Hengehold D. A., Hinkle R. T., Goodale M. B., Abeln S. B.

& Weingand K. W. (2002). Continuous low-level heat wrap therapy provides more efficacy than

ibuprofen and Acetaminophen for acute low back pain. Spine, 27(10), 1012-1017. Retrieved

from

http://ovidsp.tx.ovid.com.eproxy1.lib.hku.hk/sp-3.8.1a/ovidweb.cgi?T=JS&PAGE=fulltext&D=

ovft&AN=00007632-200205150-00003&NEWS=N&CSC=Y&CHANNEL=PubMed

Guideline topic: Superficial Heat Therapy in pain relieving

for patients with low back pain

Key Question No:

N/A

Reviewer:

LAI TSZ NING

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study� Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes ����

Can’t say �

No �

1.2 The assignment of subjects to treatment groups is randomised.

Yes �

No �

Can’t say ����

Reported but method

not described

1.3 An adequate concealment method is used.

Yes �

Can’t say �

No ����

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes ����

Can’t say �

No �

1.5 The treatment and control groups are similar at the start of the trial. Yes ����

Can’t say �

No �

1.6 The only difference between groups is the treatment under

investigation.

Yes ����

Can’t say �

No �

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes ����

Can’t say �

No �

1.8 What percentage of the individuals or clusters recruited into each Total: 2.16%

79

treatment arm of the study dropped out before the study was

completed?

Heat wrap :1.77%

Oral Acetaminophen:

1.77%

Oral Ibuprofen: 3.78%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes ����

Can’t say �

No �

Does not

apply �

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes ����

Can’t say �

No �

Does not

apply �

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)����

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes.

Single blind: investigator

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of

the study, and the extent to which it answers your question and mention any areas of

uncertainty raised above.

1. No serious adverse events occurred. 1 subject in heat wrap group was found minor

redness on day 1 which resolved 1 hour after removal of wrap.

2. Pain relief was significantly greater for the heat wrap and has higher extended pain

relief compared with oral acetaminophen and oral ibuprofen.

80

Appendix IV: SIGN Grading System 1999-2012

81

Appendix V: Summary table of Levels of Evidence of

relevant studies

Bibliography citation Study design Evidence Level

Kettenmann et al., 2007 RCT 1-

Tao X. & Bernacki, E.J., 2005a RCT 1+

Mayer et al., 2005b RCT 1+

Nuhr et al., 2004 RCT 1+

Nadler et al., 2003a RCT 1+

Nadler et al., 2003b RCT 1+

Nadler et al., 2002 RCT 1+

82

Appendix VI: Cost for Implementation of protocol

Set up Item Cost Operational Item Cost

Staff Training Workshop Venue Free / /

Computer Component + Stationary Free / /

2 RN Trainer Compensate

Hour x 2

/ /

Subtotal $16 Subtotal $0

Superficial Heat

Therapy

Heat wrap ($8 x 1300) $10400 Store Room Free

Patient’s Educational Leaflets ($0.2 x 600^) $120 Training Staff Salary Free (During

routine work)

Pain Chart Free

(Available in

ward setting)

/ /

Subtotal $10520 Subtotal $0

Total Set up Cost $10526 Total Operational Cost $0

Total $10526

Remarks:

# All costs are calculated in HK Dollars

* Attendance of Workshop: 80 responsible nurses

^ 600 patients each year receiving superficial heat therapy

83

Appendix VII: Comparison of the cost between Current Practice and Superficial Heat Therapy

Item Unit Cost Item Unit Cost

Maintaining

Current Practice

Hospital Fee

($4900 x 7 days)

$34300 Superficial Heat

Therapy

Hospital Fee

($4900 x 5 days)

$24500

Tramadol^ ($0.32/tab x 4) x

20 days*

$25.6 Heat wrap ($8 x 2) $16

Pepcidine^ ($0.06/tab x 2) x

20 days

$2.4 Educational Leaflets $0.2

Voltaren^ ($0.08/tab x 2) x

20 days

$3.2 / /

Total $34331.2 Total $24516.2

Remarks:

# All costs are calculated in HK Dollars

^ Additional Medicine regimen: Tramadol 50mg TDS + Nocte po, Pepcidine 20 mg BD po, Voltaren 25 mg BD po

* 6 days (During Hospitalization) and 14 days (Discharge medication till FU)

84

Appendix VIII: SIGN Grading System 1999 – 2012:

Grades of recommendations

At least one meta-analysis, systematic review, or RCT rated as 1++, and

directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly

applicable to the target population, and demonstrating overall consistency of

results

A body of evidence including studies rated as 2++, directly applicable to the

target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

A body of evidence including studies rated as 2+, directly applicable to the

target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

85

Appendix IX

Timeframe for Superficial Heat Therapy Program for acute Low Back Pain

Gantt chart for Implementation Plan

Week 1-4 5-8 9-14 15-21 22-23 24-25 26-30 31-34 35-36 37-38 39-47 48-52

Forming Program Team X

Communication with Ward Managers X

Communication with NC, DOM,

Consultants and COS

X

Communication with GMN and CCE X

Program team meeting for revision X X X

Announcement to frontline nurse and

physiotherapist

X

2 Training workshops X

Announcement to Patients X

Pilot Test X

Analysis for collected data X

Department meeting for evaluation X

Full implementation of the program X

Analysis for collected data; evaluate and

report the results

X

86

Appendix X

Operational Flow of Superficial Heat therapy in Pilot Test

Day 0:

- Recruiting eligible patient following the guidelines

- Explaining the details of superficial heat therapy

- Getting verbal consent

- Assessing patient’s skin integrity before applying

- Obtaining baseline data of pain intensity and sleep quality

- Applying 1st heat wrap at daytimes for 8 hours only

- Regular Assessment and taking pain score during routine work

Day 1:

- Assessing sleep quality daily

- Continue assessing pain intensity level routinely

- Applying 2nd heat wrap at daytimes for 8 hours only

- Assessing any adverse events

Day 2-3:

- Continuing assessing pain intensity level and sleep quality

Day 4:

- Continuing assessment pain intensity level and sleep quality

- Assessing patient’s satisfaction level

-

87

Appendix XI

Pain Chart

88

Appendix XII

Assessment chart for Patient using Superficial Heat therapy

Department of Orthopaedics and

Traumatology

Superficial Heat Therapy

Assessment Chart

Name:

HKID:

HN No:

Sex/D.O.B.:

(Please affix HN label)

Sleep Quality Day 0 Day 1 Day 2 Day 3 Day 4

Date:

1. How well did

you sleep last

night?

(Verbal Rating

Scale)

0 = Very poorly

1 = poorly

2 = fair

3 = well

4 = very well

5= excellent

� Please complete the following assessment on Day 4

� Please circle the appropriate box

2. How satisfied

were you with

this therapy?

Very

Dissatisfied

Dissatisfied

Neutral

Satisfied

Very

Satisfied

3. Other

Comments:

(Optional)

89

Appendix XIII

Nurses’ Evaluation form for Superficial Heat Therapy Program

Department of Orthopaedics and Traumatology

Evaluation Form on Superficial Heat Therapy

Program

Name: (optional)

Rank:

*Please indicate your level of agreement with this statement

Strongly

Disagree

Disagree Neutral Agree Strongly

Agree

1. The content of

protocol is clear to

understand.

2. The protocol is easy

to follow

3. The workload is

acceptable.

4. Change is necessary

in my workplace

5. I feel that my

professionalism is

developing

6. I am satisfied with

the protocol

7. Other Comments:

(Optional)

90

Appendix XIV

Calculation of Sample Size

P-value is set at 0.05 which the result can be considered as significant difference. 5

studies set power from 80% to 90%, but 2 studies did not provide the value.( Mayer et

al., 2005; Nuhr et al., 2004; Nadler et al., 2003a; Nadler et al., 2003b; Nadler et al.,

2002) Therefore, Power will be set at 90% for the sake for more stringent result.

Mean difference and standard deviation are obtained from the study of Tao &

Bernacki (2005) as the outcome measure is same as the one used in this protocol.

According to the result of Tao & Bernacki (2005), the mean difference is 1.1.

However, standard deviation is not provided in the study. Pain intensity score is

chatted by using a 10-point Numeric Rating Scale, the standard deviation on a

10-point scale is 50% of the maximum possible variation. Standard deviation is 2.235

which obtained by calculation.

The mean of dropout rate 7 studies is 10%, therefore the attrition rate is also set at

10% for any dropped out of the program

91

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