Complementary Therapies in Medicine (2014) 22, 26—33

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The effectiveness of Swedish massage with aromatic ginger oil in treating chronic low back pain in older adults: A randomized controlled trialNetchanok Sritoomma a,b,c,∗, Wendy Moyle a,b,1, Marie Cooke a,b,2, Siobhan O’Dwyer b,3

a School of Nursing and Midwifery, Griffith University, 170 Kessels Road, Nathan, QLD 4111, Australiab Centre for Health Practice Innovation (HPI), Griffith Health Institute, Griffith University, 170 KesselsRoad, Nathan, QLD 4111, Australiac College of Nursing, Christian University of Thailand, 144 Moo 7, Don Yai Hom, Muang, Nakhonpathom73000, ThailandAvailable online 12 November 2013

KEYWORDS Chronic low back pain;Massage;Randomized controlled trial; Ageing

SummaryObjectives: To investigate the effects of Swedish massage with aromatic ginger oil (SMGO) on chronic low back pain and disability in older adults compared with traditional Thai massage (TTM).Design: Randomized controlled trial.Setting: Massage clinic in Ratchaburi province, Thailand.Participants: 164 patients were screened; 140 were eligible, and randomized to either SMGO (n = 70) or TTM (n = 70).Intervention: Trained staff provided participants with a 30-min SMGO or TTM twice a week for five weeks.Measurement: The Visual Analogue Scale (VAS) assessed immediate effect (after each mas- sage) and the short form McGill Pain Questionnaire (MPQ) assessed effectiveness of massage in short-term (six weeks) and long-term (15 weeks). Disability improvement was measured by the Owestry Disability Questionnaire (ODQ) at baseline, short- and long-term.Results: Both SMGO and TTM led to significant improvements in pain intensity (p < 0.05) and disability (p < 0.05) across the period of assessments, indicating immediate, short- and long- term effectiveness. SMGO was more effective than TTM in reducing pain (p = 0.04) and improving disability at short- and long-term assessments ( p = 0.04).

∗ Corresponding author at: College of Nursing, Christian University of Thailand, 144 Moo 7, Don Yai Hom, Muang, Nakhonpathom 73000,

Thailand. Tel.: +66 812539361/66 34229480 9x1402; fax: +66 34229499.E-mail addresses: netchanok.sritoomma@griffithuni.edu.au, netchanoksri@yahoo.com (N. Sritoomma), w.moyle@griffith.edu.au

(W. Moyle), m.cooke@griffith.edu.au (M. Cooke), s.odwyer@griffith.edu.au (S. O’Dwyer).1 Tel.: +61 7 3735 5526; fax: +61 7 3735 5431. 2 Tel.: +61 7 3735 5253; fax: +61 7 3735 5431.3 Tel.: +61 7 3735 6619; fax: +61 7 3735 3560.

0965-2299/$ — see front matter © 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ctim.2013.11.002

The effectiveness of Swedish massage with aromatic ginger oil

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Conclusions: These findings suggest that the integration of either SMGO or TTM therapy as additional options to provide holistic care to older people with chronic low back pain could be considered by health professionals. Further research into the use of ginger as an adjunct to massage therapy, particularly TTM, is recommended.© 2013 Elsevier Ltd. All rights reserved.

Introduction

Chronic low back pain (CLBP) is a disabling condition and a major health problem, with 70—85% of people suffering low back pain (LBP) at some time in their lives,1,2 and nonspe- cific low back pain cited as the fifth most common reason for healthcare provider visits in the United States.3 Chronic low back pain is defined as a chronic condition of lower back pain lasting for at least three months or longer.2,4 In the USA, approximately 36% of community-dwelling older peo- ple experience a period of back pain every year5 and 21% of those report frequent moderate to severe pain.1 Similarly, the incidence of LBP among older people in Eastern countries such as Thailand is high, with a reported 70% of older Thai people experiencing muscle and back pain.6

CLBP impairs quality of life, restricts physical activity, reduces psychoso- cial well-being, and is therefore costly for society.7,8 CLBP costs are estimated to be more than 36 billion dollars per annum in the United States from lost work time and as a result of disability.9 Non-pharmacologic interventions for CLBP are recommended when patients do not show improve- ment with standard treatment.10

Massage is commonly used for chronic conditions includ- ing back pain.11—13 Massage has been defined as a systematic and scientific manipulation of the soft tissues of the body with rhythmical pressure and stroking for the purpose of obtaining or maintaining health.1,15 Essentially, it is a simple means of providing pain relief through physical and mental relaxation.14 It is thought to relieve pain through several pathways, including increasing the pain threshold by releas- ing endorphins16 and closing the gate of pain at the spinal cord level.17

Massage also promotes a feeling of well-being and a sense of receiving good care.1,18

Swedish massage is classified as superficial massage and consists of five main stroking actions to stimulate the circulation of blood through the soft tissues of the body.19

On the other hand, Thai massage techniques are classified as deep tissue massage with acupressure and follow two lines on the back according to the meridians energy-line theory.20

Since The Thai government has supported tradi- tional Thai medicine as national policy, Thai massage has gain credibility in the usual massage in Thailand.21 Usually, a lubricant such as an oil or powder is used with Swedish massage techniques. The skin absorbs the oils, which are taken into the bloodstream during the relatively short time of the body massage.22 It has also been suggested that an essential oil may prolong the effects of massage.23

Ginger has been used as an anti-inflammatory and anti-rheumatic for musculoskeletal pain.24—26 Three clinical trials reported the short-term beneficial pain reduction effects of ginger extract taken orally for knee or neck pain24,27,28 but no study has examined the use of ginger for back pain. Although CLBP predominately affects older people, no study has specif- ically investigated the effects of Thai massage, Swedish

28

N. Sritoomma et al.

massage and aromatherapy in older age groups. Therefore, the present study aims to examine whether CLBP in older people can be reduced by Swedish massage with aromatic ginger oil, and improve the level of disability.

Methods

Study design

A randomized controlled trial was used to investigate the effect of Swedish massage with ginger oil on older people with CLBP. The study was conducted in one massage clinic in Thailand. Participants were randomly assigned to one of two groups: Group I (treatment) received Swedish massage with aromatic ginger oil (SMGO) (2% essential ginger oil with Jojoba oil) and Group II (usual massage) received traditional Thai massage (TTM) delivered through clothing with no oil. After recruitment and screening of participants, baseline self-report assessment was conducted before the interven- tion. To assess short- and long-term effectiveness a 2nd and3rd assessment were undertaken on the 6th (short-term) and15th (long-term) week by telephone interview.

Study sample

Participants aged 60 years and older who attended the massage clinic for CLBP at the time of enrollment were screened. Those who met the following criteria were eli- gible to participate: aged 60 years and older; able to listen, speak, read and write Thai language; and diagnosed with CLBP by a medical practitioner (lasting for over 12 weeks). Individuals were not included if they had one or more of the following conditions: skin disease, inflammation or infec- tion on back, a history of back fracture or back surgery,body temperature of more than 38.5 ◦C on the examinationday, hemi/paraparesis, infectious diseases (e.g. tuberculo- sis or AIDS), cancer, prior experience of receiving any type of massage in the three months before this study. The pilot study and actual study were started after receiving ethical approval in principle. Ethical approval was gained from Grif- fith University Human Research Ethics Committee (Australia) and the Ministry of Public Health in Thailand, and the hospi- tal where the research was conducted provided permission for the conduct of the research. Each participant provided informed consent. The trial was registered with the Australia and New Zealand Trials Registry (ACTRN12612001293853).

Sample size calculations were based on a translated Ger- man study by Franke et al.40 The Visual Analogue Scale for pain (VAS) was selected as the primary outcome. A total of128 participants were needed to provide sufficient

power, using G-Power to detect an effect size of 0.5 with 95% prob- ability at an alpha of 0.05. However, to allow for a possible

10% attrition, a minimum of 70 participants was allocated to each group (n = 140 in total).

In order to conceal allocation, a statistician not involved in the study prepared a randomization schedule using a ran- dom number generated by computer with permuted block randomization (blocks of 10) prior to the enrollment of the first participant. Another person not involved in the study placed randomized numbers into opaque envelopes. The assignments were placed in sealed opaque numbered envelopes prior to the onset of the study and treatments were determined after the baseline assessments had been completed. Each person who met the eligibility criteria was given the next opaque envelope treatment in sequential order. The participants were told that they should not take pain medication in the preceding four hours or eat a meal within one hour of coming to the massage clinic to receive the assigned intervention.

Intervention

The SMGO and TTM interventions were carried out by trained healthcare professionals (physiotherapists and mas- sage therapists) who held a certificate in traditional Thai or aromatic oil massage. The treatment protocols for SMGO and TTM were evaluated for expert agreement by consensus of a panel of two experts, both intimately associated with massage and complementary therapy treatments, and both academically qualified. Massage staff were trained in the intervention using onsite training over three weeks (60 h). The massage therapists were assessed by trainers against the protocols when they completed the study training course. Participants received a 30-min massage session, two times a week for five weeks. Thus each participant had the oppor- tunity to participate in 10 sessions.

Participants in the SMGO group received Swedish mas- sage combined with aromatic ginger oil using the following five basic strokes: effleurage, petrissage, friction, tapote- ment and vibration.23

Aromatic ginger oil was selected to be the massage oil, as it is an analgesic and anti-inflammation agent, and jojoba oil as the carrier oil as the chemical com- position of jojoba closely resembles that of the skin’s natural sebum.29 The study protocol used 10 ml of jojoba oil and 2% of aromatic ginger oil for massaging. Where participants had dry skin and required additional oil during the massage, the massage therapist applied only more carrier oil, not more aromatic ginger oil.

Participants in the control group received TTM. As TTM is based on meridians energy-line theory, the treatment started from the left foot30 following the standardized pro- tocol. The massage therapist stretched the muscles, applied pressure with the palms, thumbs and elbows, all techniques addressing the energy pathway and points.30,31 TTM

was per- formed on a mattress with the client fully clothed.19,32,33

Prior to starting the actual trial, a pilot study was conducted to assess whether SMGO and TTM protocols were realis- tic and workable, and to identify practical problems and any adverse effects caused by procedures. No changes were required and no adverse events were identified. The par- ticipants in the pilot study were not included in the actual trial.

To ensure the quality and consistency of the interven- tion, periodic process observations were undertaken. There were two patterns of monitoring. Firstly, trainers randomly observed massage therapists while they performed inter- ventions with participants. Secondly, massage therapists performed both SMGO and TTM on trainers to ensure pres- sure, rhythm and stages of massaging were being delivered according to the study protocol.

Data collection and outcome measures

Trained research staff collected demographic and clinical data. Outcome data were collected June to October 2011. Outcome measures were patient-rated measurements. Pain intensity as a primary outcome was measured using two measurements: the Visual Analogue Scale for low back pain (VAS)34,35 and the McGill Pain Questionnaire (MPQ) for muscu- loskeletal pain, Thai version.36 The VAS was used before and after each massage (immediate effectiveness). The MPQ was used at baseline, and first (6th week) and second (15th week) follow-up assessments (short- and long-term effectiveness). The MPQ has three components: a set of descriptors of sensory and affective terms, Present Pain Intensity scales (PPI) and VAS. The secondary outcome was functional ability which was measured using the Oswestry Disability Question- naire (ODQ) Thai version 1.0 for back pain, high reliability with the Cronbach’s alpha coefficient for every question of the questionnaire exceeding 0.7 and all inter-item corre- lations exceeding 0.4.37 Pain medication use and adverse events were monitored over the course of the study and at the two post-intervention data collection points. No adverse events were recorded.

Data analysis

Data were entered and analyzed using the Statistical Package for Social Science (SPSS) version 18.0 and veri- fied using inspection and double entry of 10% of the data. Outcome measures were analyzed as continuous variables and presented as means and standard deviations (SD). All analyses were performed on the basis of intention-to-treat. Repeated measures ANOVA compared outcome variables at baseline (measures taken immediately before the first treat- ment) with outcome measures at six weeks and at 15 weeks after baseline treatment. This analysis compared differ- ences in outcome measures between the two intervention groups and estimated the adjusted mean differences and the 95% confidence intervals for each outcome measure at each evaluation time point.

Results

One hundred and sixty-four potential participants responded to flyers, community radio, or word-of-mouth; 24 were excluded after screening for eligibility. A total of 140 older people met the inclusion/exclusion criteria and were ran- domly assigned to the experimental group (SMGO, n = 70) and to the control group (TTM, n = 70). A flow chart of the participants’ progression through the trial is presented in Fig. 1.

Enrollment Assessed for eligibility (n=164)

Randomised(n=140)

Excluded (n=24)

Reasons for exclusion:• Less than 60 year old (n=6)• Upper back pain (n=5)• Spondylosis (n=4)• Cancer (n=1)• Skin disease (n=1)• Not fluent in Thai (n=1)• Received massage within 12

weeks of base line testing (n=6)

Swedish massage with aromatic ginger oil Traditional Thai massage

Allocated to treatment group: N=70Received allocated intervention: n=70Did not receive allocated intervention: n=0

Allocation Allocated to control group: N=70Received allocated intervention: n=70

Discontinued intervention: N=2Move out of area: n=1Surgery for Benign Prostatic Hyperplasia n=1

Lost to follow up: N=0Completed: N=70

1st follow up(6 week assessment)

Lost to follow up: N=2Completed: N=68

Lost to follow up: N=0Completed: N=70

2nd follow up(15 week assessment)

Lost to follow up: N=2Completed: N=68

Included in Intension-To-TreatAnalysis N=70

Analysis Included in Intension-To-TreatAnalysis N=70

Fig. 1 Flow chart of the progression of participants through phases of randomized controlled trial (RCT).

Table 1 Participant demographics.

Characteristics Swedish massage with ginger oil(n = 70)

Traditional Thai massage (n = 70)

Total sample(n = 140)

Group Differences

n % n % N % X2 /t p-Value

GenderFemale 54 77.1 58 82.9 112 80.0 0.71 0.26Male 16 22.9 12 17.1 28 20.0

Marital statusSingle 11 15.7 12 17.1 23 16.4 0.06 0.97Married 41 58.6 40 57.1 81 57.9Widowed 18 25.7 18 25.7 36 25.7

EducationNo education 6 8.6 4 5.7 10 7.1 7.47 0.08Primary school 54 77.1 64 91.4 118 84.3Secondary school 5 7.1 0 0 5 3.6High school 3 4.3 1 1.4 4 2.9University 2 2.9 1 1.4 3 2.1

OccupationAgriculture worker 28 40.0 22 31.4 50 35.7 8.61 0.06Labourer 22 31.4 15 21.4 37 26.4Business 8 11.4 11 15.8 19 13.6Teaching profession

2 2.9 0 0.0 2 1.4Jobless 10 14.3 22 31.4 32 22.9

Table 2 Comparison of all measurements for pain intensity at baseline, first follow-up, second follow-up assessment between the SMGO group and the TTM group.

Outcome Group Baseline assessment

1st follow up(6 week assessment)

2nd follow up(15 week assessment)

Group differences

Mean (SD) Mean (SD) Mean (SD) Mean difference p-Value*(95%CI)

SF-MPQ SMGO 14.83 (7.91) 4.31 (5.6) 6.70 (7.2) −1.67 (−3.59, 0.24) 0.087TTM 14.19 (7.49) 6.99 (6.14) 9.69 (7.61)

VAS in MPQ SMGO 66.66 (24.17) 19.31 (22.83) 26.63 (26.46) −6.37 (−12.58,

−0.17)

0.044TTM 63.27 (19.15) 27.80 (23.46) 38.64 (25.09)

PPI SMGO 2.86 (1.07) 1.10 (1.01) 1.29 (1.13) −0.15 (−0.42, 0.11) 0.256TTM 2.71 (1.04) 1.29 (0.99) 1.70 (1.18)

ODQ SMGO 26.94 (13.43) 9.11 (11.06) 12.49 (12.02) −3.66 (−7.17,

−0.14)

0.042TTM 29.49 (13.91) 12.63 (11.82) 17.40 (12.61)

* A difference at the level of p < 0.05 is considered statistically significant.SD = standard deviation; CI = confidence interval; SF-MPQ = short form McGill pain questionnaire; VAS = visual analogue scale; PPI = present pain intensity; ODQ = Oswestery Disability Questionnaire.

Demographic data and back pain characteristics are sum- marized in Table 1. Most participants (80%) were women. The majority of participants (91.4%) had only a primary school education. Approximately two-thirds (62.10%) were classified as working class. Heavy lifting was the most fre- quently reported cause of CLBP for both SMGO and TTM groups (n = 36, n = 30, respectively) followed by working long hours (n = 19 in SMGO and n = 23 in TTM). Both the SMGO and TTM groups reported medicines (n = 37 and n = 18, respec- tively) as the most frequently used previous treatment for their CLBP. There were no significant differences between the experimental and control groups in terms of demo- graphic and back pain characteristics (see Table 1). The results of the effectiveness of massage across time in rela- tion to pain are presented in Table 2. There were significant reductions in pain intensity immediately after massage in both groups when compared with pre-massage measures(P < 0.001, 95%CI = −10.75 [−11.64 to −9.86]). However,there was no significant difference between groups in themagnitude of this reduction (p = 0.85).

Table 1 There was a statistically significant interac- tion between intervention type and time with MPQ (Wilks’ Lambda = 0.94, F(2,137) = 4.06, p = 0.02, multivariate par- tial Eta squared = 0.06). There was significant change in McGill Pain Scores over time (p < 0.001) with both groups showing a reduction in MPQ across the three time periods. In relation to the VAS in the MPQ, there was significant interaction between intervention type and time (Wilks’ Lambda = 0.94, F(2,137) = 4.32, p = 0.02, multivariate partial Eta squared = 0.06)). There was also a significant difference between the SMGO group and the TTM group; the SMGO group had a greater reduction in back pain intensity than

the TTM group (MD = −6.37 95%CI −12.58 to −0.17, p = 0.04)(see Table 2).

A comparison of the PPI between the SMGO and TTM groups revealed no significant group difference (p = 0.25). However, there was a significant change in the PPI scale over

time (Wilks’ Lambda = 0.38, F(2,137) = 113.94, p < 0.001, multivariate partial Eta squared = .63) with both groups showing a reduction in PPI across these three time periods. The SMGO group showed progressively reduced back pain using the PPI scale, from a level equivalent to ‘dis-tressing pain’ (M = 2.86 ± 1.07) at baseline assessment toa level equivalent to ‘mild back pain’ (M = 1.10 ± 1.01,M = 1.29 ± 1.13) at first and second follow-up. The TTMgroup showed progressively reduced back pain from ‘dis- tressing pain’ (M = 2.71 ± 1.04) at baseline to ‘mild pain’ (M = 1.29 ± 0.99) at first follow-up and then to ‘discomfort pain’ at second follow-up (M = 1.70 ± 1.18) (see Table 2).

All measurements to assess back pain intensity found that both types of massage significantly reduced back pain inten- sity across the period of assessments indicating immediate, short- and long-term effectiveness (p < 0.05). There were no significant differences between the SMGO and TTM groups in pain immediately after massage. There was, however, a sig- nificant difference between the two groups in pain intensity at first and second follow-up. The SMGO group showed a better outcome than the TTM group in the short- and long- term. In addition, the type of pain progressively improved from ‘distressing’ to ‘mild’ to ‘discomfort’ in both types of massage.

The results of the effectiveness of massage across time in relation to disability are presented in Table 2. There was a significant change in the ODQ scale over time (p < 0.001) with both groups showing a reduction in ODQ across the three time periods (M = 28.21, 10.87 and 14.94, respec- tively (see Table 2). There was a significant difference between the SMGO and TTM groups (p < 0.05). The SMGO group had more reduction in disability than the TTM group(MD = −3.66 95%CI = −7.17 to −0.14, p = 0.041) (see Table 2).The SMGO group showed progressive reduction of disabil- ity from the level of ‘moderate disability’ (26.94 ± 13.43%)at baseline assessment to the level of ‘minimal disabil- ity’ (9.11 ± 11.06% and 12.49 ± 12.02%) at first and second

follow-up. The TTM group showed reducing disability from‘moderate disability’ (29.49 ± 13.91%) at baseline to ‘min- imal disability’ (12.63 ± 11.82% and 17.40 ± 12.61%) at firstand second follow-up (see Table 2). Both types of massage significantly improved participants’ disability ratings across the periods of assessments indicating both short- and long- term effectiveness (p < 0.05). The SMGO group’s disability level improved significantly more than the TTM group.

Discussion

The current study is the first known trial using aromatic gin- ger oil for chronic low back pain relief in older adults. Both types of massage resulted in positive change in back pain intensity over time, although there was a significant differ- ence between SMGO and TTM groups in the extent of that change. Previous studies20,38—44 have found that either Thai massage or Swedish massage can reduce back pain in the immediate and short-term (five weeks), however only one of these compared Swedish and traditional Thai massage20 and concluded that there were no clinically significant differ- ences between them in the immediate and short-term. The current study extended the assessment timeframe and found that both massage interventions could also reduce CLBP sig- nificantly in the long-term (15 weeks after completion of massage intervention).

Aromatic ginger oil was added to Swedish massage (SMGO) and was found to be more effective than TTM for back pain reduction in the short- and long-term. It seems that the addition of aromatic ginger oil enhanced the ben- efit of Swedish massage to make it more effective than TTM in reducing low back pain. Previous studies of the use of aromatic ginger in treating musculoskeletal pain, including knee pain24,27,45,46

and muscle pain,47 reported that ginger produced moderate-to-large reductions in pain.24,47

Ginger was found to be as effective as indomethacin in relieving symptoms of osteoarthritis with insignificant side effects.45

Comparing ginger with ibuprofen and a placebo in osteoarthritis, there was a statistically significant difference between the placebo, ginger and ibuprofen; the ranking of efficacy of treatments was ibuprofen> ginger > placebo.27

These studies support the findings of this study concluding that ginger has an analgesic and anti-inflammatory effect on musculoskeletal pain. However, most of the previous stud- ies used ginger as an extract rather than aromatic oil; only one study used aromatic ginger oil combined with orange essential oil46 and reported aroma-massage had potential as an alternative method for short-term knee pain relief. No previous study has tested using aromatic ginger oil for back pain reduction in an RCT.

The findings of the current study agree with those

show- ing the analgesic effects of ginger in musculoskeletal-pain of patients. The current study used the lowest concentration of the recommended range of 2—3% for ginger essential oil.46,48

The study found that 2% of aromatic ginger oil combined with ten 30-min sessions of Swedish massage was effective for older people with CLBP. Future studies may benefit from trialling a higher concentrate of 3% to assess whether this results in larger effects at the short- and long-term.

In terms of a comparison between TTM and SMGO in improvement of disability, the current study found that

both types of massage significantly improved participants’ disability ratings from the level of moderate disability to minimal disability across the period of assessment, indi- cating both short- and long-term effectiveness. However, the SMGO group improved significantly more in disabil- ity level than the TTM group. This result was in contrast to a previous study,20 which reported that clients in both massage groups, reported improvements in disability mea- surement, back performance and body flexibility, at all post-treatment assessment times. In Chatchawan et al.’s study,20 TTM improved disability more than SM immediately and at the end of the three-week treatment; however, there were no statistically significant differences on disability, back performance and body flexibility. Previous studies41,43 that compared Swedish massage with other types of massage or treatments, including acupuncture massage, soft-tissue manipulation, exercise posture, education and sham laser therapy (low-level infrared laser) on low back pain, found that Swedish massage significantly improved functional abil- ity both immediately after the massage session and in the short-term (one month). In the current study, when aromatic ginger oil was added to the Swedish-massage treatment, it was more effective than TTM for disability improvement in the short- and long-term. The therapeutic benefit of aro- matic ginger oil may be particularly beneficial for disability; however, further studies should compare SMGO with SM with base oil as a placebo group to test this assumption. Vary- ing dosages of aroma-massage with ginger oil could also be examined to see whether larger doses lead to greater effects and effects on other types of pain. Furthermore, researchers could use ginger in its different forms such as extract, aro- matic oil or herbal drink. In summary, the current study concludes that although both SMGO and TTM are effective in reducing pain, and improving disability across the period of short and long term, SMGO is more effective. The integration of massage therapy for holistic health professional practice for patients with CLBP in hospitals or aged-care facilities could be considered as a care option.

Limitations of the study are acknowledged and predom- inantly related to the study design. With the limitation of funding and time for this PhD study, the research team made a decision to have two groups (treatment and control groups) to enable a bigger sample size in each group rather than adding a third placebo group. However, the Hrobjartsson and Gotzsche reviewed study (2004) found that placebo inter- ventions in general did not have clinically important effects, but that there were possible beneficial effects on patient- reported outcomes, especially pain.49 Although, the study lacked a placebo group, it still compared the treatment intervention with a relevant control group and as such has a low risk of bias. Future studies should consider the addition of a placebo group.

Conflict of interest

No conflict of interest is declared by the authors.

Author contributions

NS, WM, and MC contributed to conception and study design; NS contributed to data collection, intervention conduction

at clinic; NS and SOD contributed to data analysis; WM, MC, SOD contributed to supervision and NS, WM, MC, and SOD contributed to manuscript preparation.

Acknowledgements

We thank the Centre for Health Practice Innovation (HPI), School of Nursing and Midwifery Griffith University, Grif- fith Graduate Research School and Christian University of Thailand for research support.

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