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The RESOLVE Trial for people with Chronic Low Back Pain: Protocol for a randomised clinical trial

Authors: Matthew K. Bagg1, 2, Markus Hübscher1, 2, Martin Rabey1, Benedict M. Wand4, Edel O’Hagan1, 2, G. Lorimer Moseley1, 3, Tasha R. Stanton1, 3, Chris G. Maher5, Stephen Goodall6, Sopany Saing6, Neil E. O’Connell7 , Hannu Luomajoki8, James H. McAuley1, 2

Institutional affiliations: 1. Neuroscience Research Australia (NeuRA), Sydney, NSW, Australia

2. Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia

3. Sansom Institute for Health Research, University of South Australia, Adelaide, SA, Australia

4. School of Physiotherapy, The University of Notre Dame Australia, Fremantle, WA, Australia

5. The George Institute for Global Health, University of Sydney, Australia

6. Centre for Health Economics Research and Evaluation, UTS Business School, University of

Technology Sydney, Australia

7. Department of Clinical Sciences, Health Economics Research Group (HERG), Institute of

Environment, Health and Societies, Brunel University London, Uxbridge, United Kingdom

8. School of Health Professions, Zurich University of Applied Sciences (ZHAW), Institute of

Physiotherapy, Winterthur, Switzerland

Human research ethics approval committee: The UNSW Human Research Ethics Committee(s) approved this study.

Human research ethics approval number: HC15357.

Protocol date: 12.8.16

Protocol for the RESOLVE randomised clinical trial 15/05/2023Bagg et al. (2016) of 19

Introduction

Low Back Pain (LBP) is the leading cause of disability worldwide 1,2 and represents a

significant economic burden both in terms of health care delivery and cost to society 3–9. After

an episode of LBP, pain and disability generally improve quickly and most people have

returned to work within three-months 10–14. However for a modest proportion, the problem

persists past three months 10,13–15, resulting in chronic LBP (CLBP) 16. Data from the USA

suggests that this proportion has increased over the previous twenty years 5,17, despite an

increase in healthcare provision 18. Persistent LBP is difficult to treat 11, accounts for

substantial productivity loss 3,9 and causes significant individual financial hardship 3,5–7,19–21.

Obtaining pain relief and improving function are of significant concern to people with CLBP 22,23. Unfortunately, randomised controlled trials have shown that most available treatments

achieve modest improvements at best 24–40. These data suggest that alternative approaches to

managing CLBP require investigation. Recently, interventions that are thought to target

central nervous system (CNS) function have been developed and tested in small studies, with

promising results 41–44. Several preliminary investigations have also combined these treatments

with traditional treatments directed towards functioning of the back and these data suggest

patients might obtain some additional benefit from a combined approach 45–48.

Treatment programs that combine CNS-directed and traditional interventions have yet to be

tested in adequately powered, prospectively registered, randomised controlled trials. The

RESOLVE Trial will be the first high quality assessment of two such treatment programs.

The aim is to compare the effectiveness of the interventions at reducing pain intensity for

people with CLBP at 18 weeks post-randomisation.

Design

Two-group, participant and assessor blinded, randomised clinical trial.


Methods

Setting

Participants will be recruited via community-based advertisements and primary care practices

in Sydney, Australia.

Participants

Participants will be screened to determine whether they meet the following inclusion and

exclusion criteria:

Inclusion Criteria: A primary complaint of pain in the area between the 12th rib and buttock

crease with or without accompanying non-radicular leg pain; episode of persistent low back

pain of at least 12 weeks duration; a mean pain intensity on a numerical rating scale (NRS) ≥

3/10 in the past week; sufficient fluency in the English language to understand and respond to

English language questionnaires and engage with the intervention; access to/availability of a

person who is able to assist with part of the intervention at home; access to the internet; aged

18-70.

Exclusion Criteria: Known or suspected serious spinal pathology (fracture; malignant,

inflammatory or infective diseases of the spine; cauda equina syndrome or widespread

neurological disorder); suspected or confirmed pregnancy or less than six months post-

partum; suspected radicular pain (dominant leg pain, positive neural tissue provocation tests

and/or any two of altered strength, reflexes or sensation for the same nerve root, assessed

clinically); spinal surgery < 12 months previously; scheduled for major surgery during the

treatment or follow-up period; uncontrolled mental health condition that precludes successful

participation; any contraindications to transcranial direct current stimulation, cranial electrical

stimulation, pulsed electromagnetic energy or low-intensity laser therapy 49–51.

Details of the interventions

Trial clinicians (physiotherapists) will undergo specific training in delivery of the

interventions. To ensure consistency of treatment delivery, the clinicians delivering the

interventions will regularly audit each other’s treatment sessions. A researcher not involved in

intervention delivery will undertake audits to ensure that the interventions are being

conducted as described in the study protocol. Timelines for the delivery of each intervention

are shown in Figures 1 and 2. Complete disclosure of the contents of the intervention has been

made with the UNSW HREC (HC15357) and an embargoed project registration has been


made on the Open Science Framework to meet the Declaration of Helsinki 52 requirement for

transparent reporting of trial methods a priori (https://osf.io/xsekt/).

Participants will be randomised to receive intervention A or intervention B. Both of the

interventions contain treatments that target CNS function, combined with treatments directed

towards functioning of the back. Participants are informed prior to providing informed

consent that some of the treatments are not active. No further information is disclosed

publicly to maintain the integrity of blinding. Adherence to the intervention will be monitored

using an individual treatment diary and adverse events recorded through passive capture.

Intervention A:

Participants randomised to Intervention A will receive a twelve-session treatment program

delivered as 60min sessions, scheduled approximately weekly, over a period of 12-18 weeks.

All treatment sessions are one-on-one. There is a home treatment component entailing 30mins

of training five times per week that finishes at session 12. The intervention comprises

discussion of the participant’s low back pain experience, graded sensory training, graded

motor imagery training and graded, precision-focused and feedback-enriched, functional

movement training. The treatments are likely to overlap, as there is a variable allocation of

time to each of the treatments within the clinic and home treatment sessions.

Discussion of the participant’s low back pain experience is conducted over the full treatment

period. This is the main focus of the intervention during the first two weeks and continues in

subsequent weeks alongside the other interventions. Graded sensory training commences in

week three. The initial phase involves localisation training in which participants practice

localising the site of tactile stimulation delivered to the low back. This is progressed to

training of both localisation and discrimination of the type of stimulation (sharp or blunt) and

finally graphaesthesia training in which participants practice recognising and interpreting

letters and digits written on the back.

Graded motor imagery training commences in week two. The first stage involves implicit

motor imagery using left-right judgement training (Recognise Online, NOIgroup, Adelaide,

Australia) and entails distinguishing between images of the trunk rotated to the left or right.

Task difficulty is progressed by increasing the complexity of the viewed images and the time

available to view them. Explicit motor imagery begins in week three, this involves watching


https://osf.io/xsekt/

videos of others moving and then mental visualisation of the viewed movement. Progression

is from simple, low-load movements to more complex, behaviourally relevant movements.

Graded precision-focused and feedback-enriched functional retraining begins in week six. An

individualised programme is provided to participants based on their relevant functional goals,

assessed at baseline. Progression is from part practice to whole task practice in an

environment with multiple opportunities for feedback.

Participant progress through the treatment programme will be guided by a standard

progression protocol (Figure 1), with mandatory advancement at certain time points.

Participants are free to progress ahead of schedule provided they meet key progression criteria

for each component of the intervention. If sustained symptom increase occurs the treatment

intensity will be reviewed and possibly reduced. Participants will not be required to stop any

current treatment for their low back pain.

Intervention B:

Participants randomised to Intervention B will receive a twelve-session treatment program of

the same duration and structure as Intervention A. The home training program finishes at

session 11 to allow sufficient time for the return of the CES device. The intervention

comprises discussion of the participant’s low back pain experience, transcranial direct current

stimulation (tDCS), cranial electrical stimulation (CES), low-intensity laser therapy and

pulsed electromagnetic energy. The treatments are not mutually exclusive and are likely to

overlap, as there is a variable allocation of time to each of the treatments within clinic

sessions.

Discussion of the participant’s low back pain experience is conducted over the full treatment

period. This is the main focus of the intervention during the first two weeks. Discussion

continues in subsequent weeks alongside the other interventions. tDCS (DC Stimulator,

NeuroConn, Ilmenau, Germany) is delivered over eleven weeks and is applied to the motor

and prefrontal cortices 53–58. Stimulation will be applied contralateral to the side of worst pain.

Application parameters will vary according to a standard protocol. Cranial electrical

stimulation is self-administered over eight weeks using a customised pre-programmed take-

home device after the participant has received due instruction from the clinician. Low-

intensity laser therapy (Model 300, Diolase, Mountain View, USA) is delivered over ten

weeks. Participants will be positioned comfortably and the laser applied to the area of greatest


pain for between 10 and 20 minutes. Application parameters will vary according to a standard

protocol. Pulsed electromagnetic energy (Curapuls, Enraf-Nonius B.V., Rotterdam, The

Netherlands) is delivered over seven weeks. Commencing in week six, pulsed electromagnetic

energy will be applied after completion of the laser therapy to the area of greatest pain for

between 10 and 20 minutes. Application parameters will be progressed according to a

standard protocol. Should sustained symptom exacerbation occur, the appropriate parameters

will be reviewed and possibly reduced. Participants will not be required to stop any current

treatment for their low back pain.

Primary and secondary outcome measures and assessment points

The primary outcome is pain intensity measured on an 11-point numerical rating scale (NRS)

at 18-weeks post-randomisation. This is a valid, reliable and responsive measure of pain

intensity 59. Secondary outcomes are as follows and reflect the IMMPACT core outcome set

for chronic pain trials 59 (see also Table 1): .

i) Roland Morris Disability Questionnaire, a valid and reliable measure of low back

related disability 60,61

ii) The depression subscale of the Depression, Anxiety and Stress Scale (DASS-21), a

valid and reliable measure of depressive symptoms. 62

iii) Pain Catastrophising Scale, a valid and reliable measure of catastrophic thoughts

relating to chronic pain. 63

iv) Tampa Scale of Kinesophobia 64, a valid and reliable measure of fear of movement 65,66.

v) Back Beliefs Questionnaire, a reliable questionnaire for examination of beliefs

around the future consequences of low back pain 67,68.

vi) Pain Self-Efficacy Questionnaire, a valid and reliable measure of a person’s beliefs

regarding their ability to undertake activities despite pain 69,70.

vii) EuroQoL (5-level) EQ-5D-5L, a valid and reliable measure of generic health status 71,72.

viii) Health care resource use (specific to LBP) and usual activities, to facilitate

economic evaluation of the interventions.

ix) Credibility and Expectancy questionnaire, a valid and reliable measure of the

credibility of an intervention, and expectations regarding treatment efficacy. 73


Assessment will occur at baseline and at 18, 26 and 52 weeks post-randomisation. Treatment

credibility will be assessed at baseline and 2 weeks post randomisation only. All

questionnaires will be accessible via secure web URLs emailed to participants individually. A

clinical assessment of symptom distribution, current symptom characteristics and behaviour,

functional limitations and behavioural responses to pain, history of the presenting complaint

and any previous back complaints, medical history, general health status, information on tests

and investigations and red flag screening is also undertaken at baseline.

Recruitment procedures

Recruitment will be conducted through both community advertisement and

physiotherapy/general medical primary care practices. Primary care practitioners will be

contacted using our clinician database and contact information freely available on the Internet.

Practitioners will be invited to recruit participants and provided with training if they are

interested. Involved practitioners will identify potentially suitable participants during their

consultation, provide them brief information about the study and invite them to contact the

research team. Posters will be distributed in the community and newspaper and radio

advertisement campaigns will be run intermittently. Upon contact by the potential participant,

a study researcher will explain the research, and with verbal consent, assess the potential

participant for study eligibility over the telephone. Potential participants who are eligible to

participate will be provided with the participant information statement and consent form

(PICF) via email or post. They will have at least 24-hours opportunity to read the PICF. If the

potential participant remains interested in participating in the study, they will be invited to a

baseline session. The researcher will discuss the time demands of taking part in the study, and

confirm that the participant is able to commit this time, to facilitate adherence to the

interventions. During the baseline session, one researcher will review the study protocol with

the participant, confirm eligibility and obtain written informed consent. Baseline outcome

data will also be collected during this session, following which the participant will be

randomised.

Randomisation procedures

A computer-generated allocation sequence will be used to allocate participants to receive

either intervention A or intervention B. The allocation sequence will be prepared using a

blocked randomisation model by a researcher with no involvement in the trial and concealed


in 275 sequentially numbered, sealed, opaque envelopes. Following completion of the

baseline assessments the treating clinician will open the envelope to reveal group allocation.

Blinding

Participants will be blind to group allocation and the study hypothesis. Blinding is an

important component of valid RCTs because it ensures that treatment expectation is evenly

matched between groups 74. It will not be possible to blind the treating clinicians. The

outcome assessors and the statistician analysing the data will be blind to group allocation.

Anticipated dates of trial commencement and completion

Commencement December 2015. Completion September 2019

Statistical analysis including sample size calculations

Sample Size Calculations: We require 275 participants to detect a 1-point (SD=2.0) between-

group difference in pain intensity (NRS), with 80% power, 5% significance level and

accounting for up to 15% loss to follow-up. We consider this to be the smallest worthwhile

effect that would justify implementation of the intervention. A one-point change on the NRS

has been suggested to be the minimally important difference for pain intensity in chronic pain

clinical trials 75. Sample size was calculated using the Glimmpse software 76. We calculated

the effect size for an interaction effect between time (four repeated observations) and

treatment, using an estimated intra-cluster correlation (correlation between the observations)

with base 0.6 and decay rate 0.1.

Statistical analysis: A statistician blinded to group status will analyse the data separately for each outcome by intention-to-treat using linear mixed models, with random intercepts accounting for the repeated measures data. Linear contrasts will be constructed to compare the adjusted mean change (continuous variables) in outcome from baseline to each time point between intervention A and intervention B. This will provide effect estimates and 95% confidence intervals for any difference between the interventions. The primary conclusions about effectiveness will be based on pain intensity at 18 weeks.

Data management

Trial data integrity will be monitored by regularly scrutinising data files for omissions and

errors. All manually entered data will be double entered and the source of any inconsistencies

will be explored and resolved. Electronic data will be stored on password-protected servers at


Neuroscience Research Australia and paper-form data stored in locked filing cabinets at

Neuroscience Research Australia. Data will only be accessible to the research team. Study

participants will be provided with an identification number. All recorded data will be coded

using this number. A secure list of participant identification numbers will be kept separate

from the de-identified data. All statistical analyses will be performed using de-identified data,

with the statistician blinded to group. Results will be disseminated using group data to ensure

confidentiality is preserved.

Participant follow-up adherence will be stimulated with careful explanation of the time

demands of participation, including follow-up during screening and at baseline, regular

contact and encouragement from a researcher with a dedicated follow-up role, personalised

correspondence and group newsletters. In addition, participants are reminded at their final

intervention session of the value of their continued involvement until the 52-week follow-up.

Significance and implications for practice

Preliminary data suggest that combining treatments that target CNS function with traditional

interventions is a promising approach to CLBP treatment. In the context of modest effects on

pain intensity from most available treatments, this approach may lead to improved clinical

outcomes for people with CLBP. The trial will determine which, if either, of two treatment

programs that combine CNS-directed and traditional interventions is more effective at

reducing pain intensity in a CLBP cohort and will follow up participants for one year,

providing important information on the persistence of any treatment effects. The applicability

of the trial results to clinical physiotherapy practice should be enhanced by the inclusion of all

people with chronic non-specific LBP from both the community and primary care settings. In

addition, the flexible structure of the intervention is more closely reflective of real-world

clinical practice than a rigid one-session per week design would be. CNS-directed

interventions constitute a completely new treatment paradigm for CLBP management. The

results have the potential to be far reaching and change current physiotherapy management of

CLBP in Australia and internationally.


References

1. Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet.

2012;379:482-491. doi:10.1016/S0140-6736(11)60610-7.

2. Collaborators GS 2013. Global, regional, and national incidence, prevalence, and years

lived with disability for 301 acute and chronic diseases and injuries in 188 countries,

1990–2013: a systematic analysis for the Global Burden of Disease Study 2013.

Lancet. 2015. doi:10.1016/S0140-6736(15)60692-4.

3. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness

studies in the United States and internationally. Spine J. 2008;8(1):8-20.

doi:10.1016/j.spinee.2007.10.005.

4. Becker A, Held H, Redaelli M, et al. Low back pain in primary care: costs of care and

prediction of future health care utilization. Spine (Phila Pa 1976). 2010;35(18):1714-

1720. doi:10.1097/BRS.0b013e3181cd656f.

5. Martin BI, Deyo RA, Mirza SK, et al. Expenditures and health status among adults

with back and neck problems. JAMA. 2008;299(6):656-664.

doi:10.1001/jama.299.6.656.

6. Depont F, Hunsche E, Abouelfath A, et al. Medical and non-medical direct costs of

chronic low back pain in patients consulting primary care physicians in France.

Fundam Clin Pharmacol. 2010;24(1):101-108. doi:10.1111/j.1472-8206.2009.00730.x.

7. Hong J, Reed C, Novick D, Happich M. Costs Associated With Treatment of Chronic

Low Back Pain. Spine (Phila Pa 1976). 2012;38(1):1.

doi:10.1097/BRS.0b013e318276450f.

8. Walker BF, Muller R, Grant WD. Low back pain in Australian adults: The economic

burden. Asia-Pacific J Public Heal. 2003;15(2):79-87.

doi:10.1177/101053950301500202.

9. Wieser S, Horisberger B, Schmidhauser S, et al. Cost of low back pain in Switzerland

in 2005. Eur J Heal Econ. 2011;12(5):455-467. doi:10.1007/s10198-010-0258-y.

10. Pengel LHM, Herbert RD, Maher CG, Refshauge KM. Acute low back pain:

systematic review of its prognosis. BMJ. 2003;327(August):323.

doi:10.1136/bmj.327.7410.323.

11. da C. Menezes Costa L, Maher CG, Hancock MJ, McAuley JH, Herbert RD, Costa

LOP. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ.

2012;184(11):1229-1230. doi:10.1503/cmaj.111271.

12. Wynne-Jones G, Cowen J, Jordan JL, et al. Absence from work and return to work in


people with back pain: a systematic review and meta-analysis. Occup Environ Med.

2014;71(6):448-456. doi:10.1136/oemed-2013-101571.

13. Henschke N, Maher CG, Refshauge KM, et al. Prognosis in patients with recent onset

low back pain in Australian primary care: inception cohort study. BMJ. 2008;337:a171.

doi:10.1136/bmj.a171.

14. Mehling WE, Gopisetty V, Bartmess E, et al. The Prognosis of Acute Low Back Pain

in Primary Care in the United States. Spine (Phila Pa 1976). 2012;37(8):678-684.

doi:10.1097/BRS.0b013e318230ab20.

15. Koes BW, Tulder MW Van, Thomas S. Clinical review Diagnosis and treatment of low

back pain. 2006;332(June). doi:10.1136/bmj.332.7555.1430.

16. Treede R-D, Rief W, Barke A, et al. A classification of chronic pain for ICD-11. Pain.

2015;156(6):1003-1007. doi:10.1097/j.pain.0000000000000160.

17. Freburger JK, Holmes GM, Agans RP, et al. The rising prevalence of chronic low back

pain. Arch Intern Med. 2009;169(3):251-258. doi:10.1001/archinternmed.2008.543.

18. Deyo R a, Mirza SK, Turner J a, Martin BI. Overtreating chronic back pain: time to

back off? J Am Board Fam Med. 2009;22(1):62-68.

doi:10.3122/jabfm.2009.01.080102.

19. Schofield DJ, Shrestha RN, Percival R, Callander EJ, Kelly SJ, Passey ME. Early

retirement and the financial assets of individuals with back problems. Eur Spine J.

2011;20(5):731-736. doi:10.1007/s00586-010-1647-8.

20. Schofield DJ, Kelly S, Shrestha R, Callander E, Passey M, Percival R. The impact of

back problems on retirement wealth. Pain. 2012;153(1):203-210.

doi:10.1016/j.pain.2011.10.018.

21. Schofield DJ, Callander EJ, Shrestha RN, Percival R, Kelly SJ, Passey ME. Labor

Force Participation and the Influence of Having Back Problems on Income Poverty in

Australia. Spine (Phila Pa 1976). 2012;37(13):1156-1163.

doi:10.1097/BRS.0b013e31824481ee.

22. Hush JM, Refshauge K, Sullivan G, De Souza L, Maher CG, McAuley JH. Recovery:

what does this mean to patients with low back pain? Arthritis Rheum. 2009;61(1):124-

131. doi:10.1002/art.24162.

23. Verbeek J, Sengers M-J, Riemens L, Haafkens J. Patient Expectations of Treatment for

Back Pain. Spine (Phila Pa 1976). 2004;29(20):2309-2318.

doi:10.1097/01.brs.0000142007.38256.7f.

24. Machado L a C, Kamper SJ, Herbert RD, Maher CG, Mcauley JH. Analgesic effects of


treatments for non-specific low back pain: A meta-analysis of placebo-controlled

randomized trials. Rheumatology. 2009;48(November 2008):520-527.

doi:10.1093/rheumatology/ken470.

25. Hayden JA, Tulder MW Van, Malmivaara A V, Koes BW. Meta-Analysis: Exercise

Therapy for Nonspecific Low Back Pain. Ann Intern Med. 2005;142:765-775.

doi:10.7326/0003-4819-142-9-200505030-00013.

26. Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic

low back pain: A systematic review and meta-analysis of randomised controlled trials.

Clin Rehabil. 2015. doi:10.1177/0269215515570379.

27. Wells C, Kolt GS, Marshall P, Hill B, Bialocerkowski A. The effectiveness of pilates

exercise in people with chronic low back pain: A systematic review. PLoS One.

2014;9(7):16-20. doi:10.1371/journal.pone.0100402.

28. Kamper SJ, Apeldoorn a. T, Chiarotto A, et al. Multidisciplinary biopsychosocial

rehabilitation for chronic low back pain: Cochrane systematic review and meta-

analysis. BMJ. 2015;350(feb18 5):h444-h444. doi:10.1136/bmj.h444.

29. Henschke N, Ostelo RWJG, Van Tulder MW, et al. Behavioural treatment for chronic

low-back pain ( Review ). Cochrane Database Syst Rev. 2010;(7).

doi:10.1002/14651858.CD002014.pub3.

30. Richmond H, Hall AM, Copsey B, et al. The Effectiveness of Cognitive Behavioural

Treatment for Non-Specific Low Back Pain: A Systematic Review and Meta-Analysis.

PLoS One. 2015;10(8):e0134192. doi:10.1371/journal.pone.0134192.

31. Öst L-G. The efficacy of Acceptance and Commitment Therapy: An updated

systematic review and meta-analysis. Behav Res Ther. 2014;61.

doi:10.1016/j.brat.2014.07.018.

32. Ibrahim T, Tleyjeh IM, Gabbar O. Surgical versus non-surgical treatment of chronic

low back pain: A meta-analysis of randomised trials. Int Orthop. 2008;32(1):107-113.

doi:10.1007/s00264-006-0269-6.

33. Lam M, Galvin R, Curry P. Effectiveness of Acupuncture for Nonspecific Chronic

Low Back Pain: A Systematic Review and Meta-analysis. Spine (Phila Pa 1976).

2013;38(24):2124-2138. doi:10.1097/01.brs.0000435025.65564.b7.

34. Orrock PJ, Myers SP. Osteopathic intervention in chronic non-specific low back pain: a

systematic review. BMC Musculoskelet Disord. 2013;14(1):129. doi:10.1186/1471-

2474-14-129.

35. Chaparro LE, Furlan AD, Deshpande A, Mailis-Gagnon A, Atlas S, Turk DC. Opioids


compared with placebo or other treatments for chronic low back pain: an update of the

Cochrane Review. Spine (Phila Pa 1976). 2014;39(7):556-563.

doi:10.1097/BRS.0000000000000249.

36. Oltean H, Robbins C, Mw VT, Bm B, Bombardier C, Jj G. Herbal medicine for low-

back pain (Review). Cochrane Database Syst Rev. 2014;(12).

doi:10.1002/14651858.CD004504.pub4.

37. Roelofs PDDM, Deyo RA, Koes BW, Scholten RJPM, Van Tulder MW. Non-steroidal

anti-inflammatory drugs for low back pain ( Review ). Cochrane Database Syst Rev.

2008;(1). doi:10.1002/14651858.CD000396.pub3.

38. Urquhart DM, Hoving JL, Assendelft WJ, Roland M, Van Tulder MW.

Antidepressants for non-specific low back pain ( Review ). Cochrane Database Syst

Rev. 2008;(1). doi:10.1002/14651858.CD001703.pub3.

39. Van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM. Muscle relaxants for

non-specific low-back pain ( Review ). Cochrane Database Syst Rev. 2003;(4).

doi:10.1002/14651858.CD004252.

40. O’Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain

stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014;

(4):CD008208. doi:10.1002/14651858.CD008208.pub2.

41. Wand BM, Abbaszadeh S, Smith AJ, Catley MJ, Moseley GL. Acupuncture applied as

a sensory discrimination training tool decreases movement - related pain in patients

with chronic low back pain more than acupuncture alone : a randomised cross - over

experiment. Br J Sport Med. 2013;47:1085-1089. doi:10.1136/bjsports-2013-092949.

42. Wand BM, Tulloch VM, George PJ, et al. Seeing it helps: movement-related back pain

is reduced by visualization of the back during movement. Clin J Pain. 2012;28(7):602-

608. doi:10.1097/AJP.0b013e31823d480c.

43. Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Welding M. Immediate effects of

sensory discrimination for chronic low back pain: a case series. New Zeal J Physiother.

2015;43(2). doi:10.15619/NZJP/43.2.06.

44. Diers M, Löffler A, Zieglgänsberger W, Trojan J. Watching your pain site reduces pain

intensity in chronic back pain patients. Eur J Pain. 2016;20(4):581-585.

doi:10.1002/ejp.765.

45. Wand BM, O’Connell NE, Di Pietro F, Bulsara M. Managing chronic nonspecific low

back pain with a sensorimotor retraining approach: exploratory multiple-baseline study

of 3 participants. Phys Ther. 2011;91(4):535-546. doi:10.2522/ptj.20100150.


46. Wälti P, Kool J, Luomajoki H. Short-term effect on pain and function of

neurophysiological education and sensorimotor retraining compared to usual

physiotherapy in patients with chronic or recurrent non-specific low back pain, a pilot

randomized controlled trial. BMC Musculoskelet Disord. 2015;16(1):1-11.

doi:10.1186/s12891-015-0533-2.

47. Schabrun SM, Jones E, Cancino ELE, Hodges PW. Brain Stimulation Targeting

Chronic Recurrent Low Back Pain From the Top-down and the Bottom-up : A

Combined Transcranial Direct Current Stimulation and Peripheral Electrical

Stimulation Intervention. Brain Stimul. 2014;7:1-9. doi:10.1016/j.brs.2014.01.058.

48. Trapp W, Weinberger M, Erk S, et al. A brief intervention utilising visual feedback

reduces pain and enhances tactile acuity in CLBP patients. J Back Musculoskelet

Rehabil. 2014;0:1-10. doi:10.3233/BMR-140561.

49. Constantinescu AO, Ilie A, Moldovan M, Stagg CJ. Trans-Cranial Direct Current

Stimulation (tDCS): A Promising New Tool to Facilitate Rehabilitation of Manual

Dexterity After Stroke. Rom J Neurol. 2010;9(3):118-123.

50. Global D. Low Level Laser Therapy 101.

https://www.djoglobal.com/sites/default/files/Low Level Laser Therapy 101.pdf.

51. Shields N, Gormley J, O’Hare N. Contraindications To Continuous And Pulsed Short-

wave Diathermy. Phys Ther Rev. 2002;7(2):133-143.

doi:10.1179/108331902125002599.

52. WMA. WMA Declaration of Helsinki - Ethical Principles for Medical Research

Involving Human Subjects.; 2008.

http://www.wma.net/en/30publications/10policies/b3/index.html.

53. Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): A tool for

double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol.

2006;117(4):845-850. doi:10.1016/j.clinph.2005.12.003.

54. Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by

weak transcranial direct current stimulation. J Physiol. 2000;527:633-639.

doi:10.1111/j.1469-7793.2000.t01-1-00633.x.

55. Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for

transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol.

2003;114(1):2220-2222. doi:10.1016/S1388-2457(03)00235-9.

56. Fertonani A, Ferrari C, Miniussi C. What do you feel if I apply transcranial electric

stimulation ? Safety , sensations and secondary induced effects. Clin Neurophysiol.


2015;126(11):2181-2188. doi:10.1016/j.clinph.2015.03.015.

57. Turi Z, Ambrus GG, Ho KA, Sengupta T, Paulus W, Antal A. When size matters:

Large electrodes induce greater stimulation-related cutaneous discomfort than smaller

electrodes at equivalent current density. Brain Stimul. 2014;7(3):460-467.

doi:10.1016/j.brs.2014.01.059.

58. Dundas JE, Thickbroom GW, Mastaglia FL. Perception of comfort during transcranial

DC stimulation: Effect of NaCl solution concentration applied to sponge electrodes.

Clin Neurophysiol. 2007;118(5):1166-1170. doi:10.1016/j.clinph.2007.01.010.

59. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain

clinical trials: IMMPACT recommendations. Pain. 2005;113(1-2):9-19.

doi:10.1016/j.pain.2004.09.012.

60. Roland M. The Roland-Morris Disability Questionnaire and the Oswestry Disability

Questionnaire. Spine (Phila Pa 1976). 2000;25:3115-3124.

61. Roland M, Morris R. A study of the natural history of back pain. Part I: development of

a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976).

1983;8:141-144.

62. Lovibond S, Lovibond P. Manual for the Depression Anxiety Stress Scales. Sydney:

School of Psychology, University of New South Wales; 1995.

63. Sullivan MJ, Bishop S, Pivik J. The Pain Catastrophizing Scale: development and

validation. Psychol Assess. 1995;7:524-532.

64. Kori SH, Miller RP, Todd DD. Kinesiophobia: A new view of chronic pain behaviour.

Pain Management. Pain Manag. 1990;3(1):35-43.

65. Lundberg MK, Styf J, Carlsson SG. A psychometric evaluation of the Tampa Scale for

Kinesiophobia—from a physiotherapeutic perspective. Physiother Theory Pract.

2004;20(2):121-133.

66. Roelofs J, Goubert L, Peters ML, Vlaeyen JWS, Crombez G. The Tampa Scale for

Kinesiophobia: Further examination of psychometric properties in patients with

chronic low back pain and fibromyalgia. Eur J Pain. 2004;8(5):495-502.

doi:10.1016/j.ejpain.2003.11.016.

67. Symonds TL, Burton K, Tillotson KM, Main CJ. Absence resulting from low back

trouble can be reduced by psychosocial intervention at the work place.pdf. Spine (Phila

Pa 1976). 1996;20(24):2738-2745.

68. Symonds TL, Burton K, Tillotson KM, Main CJ. Do attitudes and beliefs influence

work loss due to low back trouble? Occup Med (Lond). 1996;46(1):25-32.


doi:10.1093/occmed/46.1.25.

69. Kaivanto KK, Estlander AM, Moneta GB, Vanharanta H. Isokinetic performance in

low back pain patients: The predictive power of the Self-Efficacy Scale. J Occup

Rehabil. 1995;5(2):87-99.

70. Asghari A, Nicholas MK. Pain self-efficacy beliefs and pain behaviour. A prospective

study. Pain. 2001;94(1):85-100. doi:10.1016/S0304-3959(01)00344-X.

71. Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new

five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727-1736.

doi:10.1007/s11136-011-9903-x.

72. Janssen MF, Birnie E, Haagsma JA, Bonsel G. Comparing the Standard EQ-5D Three-

Level System with a Five-Level Version. Value Heal. 2008;11(2):275-284.

doi:10.1111/j.1440-1754.2007.01273.x.

73. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy

questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73-86.

74. Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.

3rd ed. Upper Saddle River, New Jersey: Pearson Education; 2009.

75. Busse JW, Bartlett SJ, Dougados M, et al. Optimal Strategies for Reporting Pain in

Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12

Workshop. J Rheumatol. 2015;42(6):1-9. doi:10.3899/jrheum.141440.

76. Muller KE, Glueck D. GLIMMPSE. 2016. http://glimmpse.samplesizeshop.org/#/.


Competing interests:GLM: GLM receives royalties for books about pain and rehabilitation. GLM receives speaker’s fees for lectures on pain and rehabilitation. GLM received payment for contributions to Pfizer’s web-based pain education strategy. GLM consults to Kaiser Permanente, USA, workers’ compensation boards in Australia, North America and Europe has been supported by Agile Physiotherapy and Results Physiotherapy, USA. Treatments devised by GLM are incorporated into the treatments under investigation in the current trial. To minimise the risk of conflict, GLM will have no role in data collection or analysis in the current trial. TRS: TRS received travel and accommodation support from Eli Lilly Ltd. for speaking engagements in Canada (September 2014); this was unrelated to the present topic.

Source(s) of support:This work is funded by National Health and Medical Research Council of Australia (NHMRC) grant ID 1087045.MKB is supported by an Australian Postgraduate Award, a UNSW Research Excellence Award and a NeuRA PhD Candidature Top-Up Scholarship. GLM is supported by an NHMRC Principal Research Fellowship, NHMRC ID 1061279.TRS is supported by an NHMRC Early Career Fellowship, NHMRC ID 1054041.JHM is supported by NHMRC grants 1087045 and 1047827. CGM is supported by an NHMRC Principal Research Fellowship, NHMRC ID 1103022

Acknowledgements: Mr Michael Cartwright, Mr Andrew Cartwright and Mr Gauraw Rijal; Information Technology, Neuroscience Research Australia, Sydney, AustraliaAssoc Professor Tom Weickert; Neuroscience Research Australia, Sydney, AustraliaMr Stevan Nikolin; Black Dog Institute, Sydney, AustraliaAssoc Prof David Butler, Mr Tim Cocks; NOIgroup, Adelaide, AustraliaWe thank Drs Brigid Betz-Stablein and Nancy Briggs (Stats Central, Mark Wainwright Analytical Centre, UNSW) for reviewing our sample size calculation and statistical analysis plan.We thank Dr Roberta Chow (Quantum Pain Management, Sydney) for assistance with treatment equipment.


Table 1 PRIMARY AND SECONDARY OUTCOME MEASURES.

Measures Primary outcome

Secondary Outcome

References

Assessed at:__ weeks post randomisation

__ weeks post randomisation

Pain intensity (0-10 Numerical Rating Scale) 18 0, 26, 52 59

Roland Morris Disability Questionnaire 18, 26, 52 60,61

Depression subscale of the Depression, Anxiety and Stress Scale (DASS-21)

18, 26, 52 62

Pain Catastrophising Scale 18, 26, 52 63

Tampa Scale of Kinesiophobia 18, 26, 52 64–66

Back Beliefs Questionnaire 18, 26, 52 67,68

Pain Self-Efficacy Questionnaire 18, 26, 52 69,70

EuroQoL (5 level) EQ-5D-5L 18, 26, 52 71,72

Health care resource use 18, 26, 52 NACredibility and Expectancy Questionnaire 0, 2 73


Figure 1. TIMELINE FOR INTERVENTION A. Lighter squares denote possible continuation of component of intervention if necessary.

Figure 2. TIMELINE FOR INTERVENTION B.


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