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he effectiveness of Swedish massage withromatic ginger oil in treating chronic lowack pain in older adults: A randomizedontrolled trial

etchanok Sritoommaa,b,c,∗, Wendy Moylea,b,1,arie Cookea,b,2, Siobhan O’Dwyerb,3

School of Nursing and Midwifery, Griffith University, 170 Kessels Road, Nathan, QLD 4111, AustraliaCentre for Health Practice Innovation (HPI), Griffith Health Institute, Griffith University, 170 Kesselsoad, Nathan, QLD 4111, AustraliaCollege of Nursing, Christian University of Thailand, 144 Moo 7, Don Yai Hom, Muang, Nakhonpathom3000, Thailandvailable online 12 November 2013

KEYWORDSChronic low backpain;Massage;Randomizedcontrolled trial;Ageing

SummaryObjectives: To investigate the effects of Swedish massage with aromatic ginger oil (SMGO) onchronic 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 forfive 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 theOwestry Disability Questionnaire (ODQ) at baseline, short- and long-term.Results: Both SMGO and TTM led to significant improvements in pain intensity (p < 0.05) anddisability (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 improvingdisability 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,hailand. 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.auW. 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.

965-2299/$ — see front matter © 2013 Elsevier Ltd. All rights reserved.ttp://dx.doi.org/10.1016/j.ctim.2013.11.002

The effectiveness of Swedish massage with aromatic ginger oil

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Introduction

Chronic low back pain (CLBP) is a disabling condition and amajor health problem, with 70—85% of people suffering lowback pain (LBP) at some time in their lives,1,2 and nonspe-cific low back pain cited as the fifth most common reason forhealthcare provider visits in the United States.3 Chronic lowback pain is defined as a chronic condition of lower backpain lasting for at least three months or longer.2,4 In theUSA, approximately 36% of community-dwelling older peo-ple experience a period of back pain every year5 and 21% ofthose report frequent moderate to severe pain.1 Similarly,the incidence of LBP among older people in Eastern countriessuch as Thailand is high, with a reported 70% of older Thaipeople experiencing muscle and back pain.6 CLBP impairsquality of life, restricts physical activity, reduces psychoso-cial well-being, and is therefore costly for society.7,8 CLBPcosts are estimated to be more than 36 billion dollars perannum in the United States from lost work time and asa result of disability.9 Non-pharmacologic interventions forCLBP 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 systematicand scientific manipulation of the soft tissues of the bodywith rhythmical pressure and stroking for the purpose ofobtaining or maintaining health.1,15 Essentially, it is a simplemeans of providing pain relief through physical and mentalrelaxation.14 It is thought to relieve pain through severalpathways, including increasing the pain threshold by releas-ing endorphins16 and closing the gate of pain at the spinalcord level.17 Massage also promotes a feeling of well-beingand a sense of receiving good care.1,18

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

On the other hand, Thai massage techniques are classifiedas deep tissue massage with acupressure and follow twolines on the back according to the meridians energy-linetheory.20 Since The Thai government has supported tradi-tional Thai medicine as national policy, Thai massage hasgain credibility in the usual massage in Thailand.21 Usually,a lubricant such as an oil or powder is used with Swedishmassage techniques. The skin absorbs the oils, which aretaken into the bloodstream during the relatively short timeof the body massage.22 It has also been suggested that anessential oil may prolong the effects of massage.23 Gingerhas been used as an anti-inflammatory and anti-rheumaticfor musculoskeletal pain.24—26 Three clinical trials reportedthe short-term beneficial pain reduction effects of gingerextract taken orally for knee or neck pain24,27,28 but no study

has examined the use of ginger for back pain. Although CLBPpredominately affects older people, no study has specif-ically investigated the effects of Thai massage, Swedish

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27

gest that the integration of either SMGO or TTM therapy aslistic care to older people with chronic low back pain couldnals. Further research into the use of ginger as an adjunct to, is recommended.

erved.

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

ethods

tudy design

randomized controlled trial was used to investigate theffect of Swedish massage with ginger oil on older peopleith CLBP. The study was conducted in one massage clinic

n Thailand. Participants were randomly assigned to one ofwo groups: Group I (treatment) received Swedish massageith aromatic ginger oil (SMGO) (2% essential ginger oil withojoba oil) and Group II (usual massage) received traditionalhai massage (TTM) delivered through clothing with no oil.fter recruitment and screening of participants, baselineelf-report assessment was conducted before the interven-ion. To assess short- and long-term effectiveness a 2nd andrd assessment were undertaken on the 6th (short-term) and5th (long-term) week by telephone interview.

tudy sample

articipants aged 60 years and older who attended theassage clinic for CLBP at the time of enrollment were

creened. Those who met the following criteria were eli-ible to participate: aged 60 years and older; able to listen,peak, read and write Thai language; and diagnosed withLBP by a medical practitioner (lasting for over 12 weeks).

ndividuals were not included if they had one or more of theollowing conditions: skin disease, inflammation or infec-ion on back, a history of back fracture or back surgery,ody temperature of more than 38.5 ◦C on the examinationay, hemi/paraparesis, infectious diseases (e.g. tuberculo-is or AIDS), cancer, prior experience of receiving any typef massage in the three months before this study. The pilottudy and actual study were started after receiving ethicalpproval in principle. Ethical approval was gained from Grif-th University Human Research Ethics Committee (Australia)nd the Ministry of Public Health in Thailand, and the hospi-al where the research was conducted provided permissionor the conduct of the research. Each participant providednformed consent. The trial was registered with the Australiand New Zealand Trials Registry (ACTRN12612001293853).

Sample size calculations were based on a translated Ger-an study by Franke et al.40 The Visual Analogue Scale forain (VAS) was selected as the primary outcome. A total of

28 participants were needed to provide sufficient power,sing G-Power to detect an effect size of 0.5 with 95% prob-bility at an alpha of 0.05. However, to allow for a possible

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0% attrition, a minimum of 70 participants was allocatedo each group (n = 140 in total).

In order to conceal allocation, a statistician not involvedn the study prepared a randomization schedule using a ran-om number generated by computer with permuted blockandomization (blocks of 10) prior to the enrollment ofhe first participant. Another person not involved in thetudy placed randomized numbers into opaque envelopes.he assignments were placed in sealed opaque numberednvelopes prior to the onset of the study and treatmentsere determined after the baseline assessments had beenompleted. Each person who met the eligibility criteria wasiven the next opaque envelope treatment in sequentialrder. The participants were told that they should not takeain medication in the preceding four hours or eat a mealithin one hour of coming to the massage clinic to receive

he assigned intervention.

ntervention

he SMGO and TTM interventions were carried out byrained healthcare professionals (physiotherapists and mas-age therapists) who held a certificate in traditional Thair aromatic oil massage. The treatment protocols for SMGOnd TTM were evaluated for expert agreement by consensusf a panel of two experts, both intimately associated withassage and complementary therapy treatments, and both

cademically qualified. Massage staff were trained in thentervention using onsite training over three weeks (60 h).he massage therapists were assessed by trainers against therotocols when they completed the study training course.articipants received a 30-min massage session, two times

week for five weeks. Thus each participant had the oppor-unity to participate in 10 sessions.

Participants in the SMGO group received Swedish mas-age combined with aromatic ginger oil using the followingve basic strokes: effleurage, petrissage, friction, tapote-ent and vibration.23 Aromatic ginger oil was selected to be

he massage oil, as it is an analgesic and anti-inflammationgent, and jojoba oil as the carrier oil as the chemical com-osition of jojoba closely resembles that of the skin’s naturalebum.29 The study protocol used 10 ml of jojoba oil and 2%f aromatic ginger oil for massaging. Where participants hadry skin and required additional oil during the massage, theassage therapist applied only more carrier oil, not more

romatic ginger oil.Participants in the control group received TTM. As TTM

s based on meridians energy-line theory, the treatmenttarted from the left foot30 following the standardized pro-ocol. The massage therapist stretched the muscles, appliedressure with the palms, thumbs and elbows, all techniquesddressing the energy pathway and points.30,31 TTM was per-ormed on a mattress with the client fully clothed.19,32,33

rior to starting the actual trial, a pilot study was conductedo assess whether SMGO and TTM protocols were realis-ic and workable, and to identify practical problems and

ny adverse effects caused by procedures. No changes wereequired and no adverse events were identified. The par-icipants in the pilot study were not included in the actualrial.

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N. Sritoomma et al.

To ensure the quality and consistency of the interven-ion, periodic process observations were undertaken. Thereere two patterns of monitoring. Firstly, trainers randomlybserved massage therapists while they performed inter-entions with participants. Secondly, massage therapistserformed both SMGO and TTM on trainers to ensure pres-ure, rhythm and stages of massaging were being deliveredccording to the study protocol.

ata collection and outcome measures

rained research staff collected demographic and clinicalata. Outcome data were collected June to October 2011.utcome measures were patient-rated measurements. Pain

ntensity as a primary outcome was measured using twoeasurements: the Visual Analogue Scale for low back pain

VAS)34,35 and the McGill Pain Questionnaire (MPQ) for muscu-oskeletal pain, Thai version.36 The VAS was used before andfter each massage (immediate effectiveness). The MPQ wassed at baseline, and first (6th week) and second (15th week)ollow-up assessments (short- and long-term effectiveness).he MPQ has three components: a set of descriptors ofensory and affective terms, Present Pain Intensity scalesPPI) and VAS. The secondary outcome was functional abilityhich was measured using the Oswestry Disability Question-aire (ODQ) Thai version 1.0 for back pain, high reliabilityith the Cronbach’s alpha coefficient for every question of

he questionnaire exceeding 0.7 and all inter-item corre-ations exceeding 0.4.37 Pain medication use and adversevents were monitored over the course of the study and athe two post-intervention data collection points. No adversevents were recorded.

ata analysis

ata were entered and analyzed using the Statisticalackage for Social Science (SPSS) version 18.0 and veri-ed using inspection and double entry of 10% of the data.utcome measures were analyzed as continuous variablesnd presented as means and standard deviations (SD). Allnalyses were performed on the basis of intention-to-treat.epeated measures ANOVA compared outcome variables ataseline (measures taken immediately before the first treat-ent) with outcome measures at six weeks and at 15 weeks

fter baseline treatment. This analysis compared differ-nces in outcome measures between the two interventionroups and estimated the adjusted mean differences andhe 95% confidence intervals for each outcome measure atach evaluation time point.

esults

ne hundred and sixty-four potential participants respondedo flyers, community radio, or word-of-mouth; 24 werexcluded after screening for eligibility. A total of 140 oldereople met the inclusion/exclusion criteria and were ran-

omly assigned to the experimental group (SMGO, n = 70)nd to the control group (TTM, n = 70). A flow chart of thearticipants’ progression through the trial is presented inig. 1.

The effectiveness of Swedish massage with aromatic ginger oil 29

Assessed for eligibility (n=164)

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)

Randomised

(n=140)

Excluded (n=24)

Traditional Thai massageSwedish massage with

aromatic ginger oil

Allocated to treatment group: N=70

Received allocated interv ention: n=70

Did not receive allocated intervention: n=0

Lost to follow up: N=0

Completed: N=70

Allocated to control group: N=70

Received all ocated interv ention: n=70

Discontinued intervention: N=2

Move out of area: n= 1

Surgery for Benign Prostatic Hyperplasia n=1

Allocation

Lost to follo w up: N=0

Completed: N=70

Lost to foll ow up: N=2

Completed : N=68

1st follo w up

(6 week assessment)

Lost to foll ow up: N=2

Completed : N=68

2nd follo w up

(15 week assessment)

Included in Intension-To-Treat

Analysis N=70

Included in Intension-To-Treat

Analysis N=70Analysis

Enrollment

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

Table 1 Participant demographics.

Characteristics Swedish massagewith ginger oil(n = 70)

Traditional Thaimassage (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

30 N. Sritoomma et al.

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

Outcome Group Baseline assessment 1st followup(6 weekassessment)

2nd followup(15 weekassessment)

Group differences

Mean (SD) Mean (SD) Mean (SD) Mean difference(95%CI)

p-Value*

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.rm M

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SD = standard deviation; CI = confidence interval; SF-MPQ = short fopain intensity; ODQ = Oswestery Disability Questionnaire.

Demographic data and back pain characteristics are sum-arized in Table 1. Most participants (80%) were women.he majority of participants (91.4%) had only a primarychool education. Approximately two-thirds (62.10%) werelassified as working class. Heavy lifting was the most fre-uently reported cause of CLBP for both SMGO and TTMroups (n = 36, n = 30, respectively) followed by working longours (n = 19 in SMGO and n = 23 in TTM). Both the SMGO andTM groups reported medicines (n = 37 and n = 18, respec-ively) as the most frequently used previous treatment forheir CLBP. There were no significant differences betweenhe experimental and control groups in terms of demo-raphic and back pain characteristics (see Table 1). Theesults of the effectiveness of massage across time in rela-ion to pain are presented in Table 2. There were significanteductions in pain intensity immediately after massage inoth groups when compared with pre-massage measuresP < 0.001, 95%CI = −10.75 [−11.64 to −9.86]). However,here was no significant difference between groups in theagnitude of this reduction (p = 0.85).Table 1 There was a statistically significant interac-

ion between intervention type and time with MPQ (Wilks’ambda = 0.94, F(2,137) = 4.06, p = 0.02, multivariate par-ial Eta squared = 0.06). There was significant change incGill Pain Scores over time (p < 0.001) with both groups

howing a reduction in MPQ across the three time periods.n relation to the VAS in the MPQ, there was significantnteraction between intervention type and time (Wilks’ambda = 0.94, F(2,137) = 4.32, p = 0.02, multivariate partialta squared = 0.06)). There was also a significant differenceetween the SMGO group and the TTM group; the SMGOroup had a greater reduction in back pain intensity thanhe 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 TTMroups revealed no significant group difference (p = 0.25).owever, there was a significant change in the PPI scale over

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cGill pain questionnaire; VAS = visual analogue scale; PPI = present

ime (Wilks’ Lambda = 0.38, F(2,137) = 113.94, p < 0.001,ultivariate partial Eta squared = .63) with both groups

howing a reduction in PPI across these three time periods.he SMGO group showed progressively reduced back painsing the PPI scale, from a level equivalent to ‘dis-ressing pain’ (M = 2.86 ± 1.07) at baseline assessment to

level equivalent to ‘mild back pain’ (M = 1.10 ± 1.01, = 1.29 ± 1.13) at first and second follow-up. The TTMroup showed progressively reduced back pain from ‘dis-ressing pain’ (M = 2.71 ± 1.04) at baseline to ‘mild pain’M = 1.29 ± 0.99) at first follow-up and then to ‘discomfortain’ at second follow-up (M = 1.70 ± 1.18) (see Table 2).

All measurements to assess back pain intensity found thatoth types of massage significantly reduced back pain inten-ity across the period of assessments indicating immediate,hort- and long-term effectiveness (p < 0.05). There were noignificant differences between the SMGO and TTM groups inain immediately after massage. There was, however, a sig-ificant difference between the two groups in pain intensityt first and second follow-up. The SMGO group showed aetter outcome than the TTM group in the short- and long-erm. In addition, the type of pain progressively improvedrom ‘distressing’ to ‘mild’ to ‘discomfort’ in both types ofassage.The results of the effectiveness of massage across time

n relation to disability are presented in Table 2. There was significant change in the ODQ scale over time (p < 0.001)ith both groups showing a reduction in ODQ across the

hree time periods (M = 28.21, 10.87 and 14.94, respec-ively (see Table 2). There was a significant differenceetween the SMGO and TTM groups (p < 0.05). The SMGOroup had more reduction in disability than the TTM groupMD = −3.66 95%CI = −7.17 to −0.14, p = 0.041) (see Table 2).

he SMGO group showed progressive reduction of disabil-

ty from the level of ‘moderate disability’ (26.94 ± 13.43%)t baseline assessment to the level of ‘minimal disabil-ty’ (9.11 ± 11.06% and 12.49 ± 12.02%) at first and second

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The effectiveness of Swedish massage with aromatic ginger

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 massagesignificantly improved participants’ disability ratings acrossthe periods of assessments indicating both short- and long-term effectiveness (p < 0.05). The SMGO group’s disabilitylevel 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. Bothtypes of massage resulted in positive change in back painintensity over time, although there was a significant differ-ence between SMGO and TTM groups in the extent of thatchange. Previous studies20,38—44 have found that either Thaimassage or Swedish massage can reduce back pain in theimmediate and short-term (five weeks), however only one ofthese compared Swedish and traditional Thai massage20 andconcluded that there were no clinically significant differ-ences between them in the immediate and short-term. Thecurrent study extended the assessment timeframe and foundthat both massage interventions could also reduce CLBP sig-nificantly in the long-term (15 weeks after completion ofmassage intervention).

Aromatic ginger oil was added to Swedish massage(SMGO) and was found to be more effective than TTM forback pain reduction in the short- and long-term. It seemsthat the addition of aromatic ginger oil enhanced the ben-efit of Swedish massage to make it more effective thanTTM in reducing low back pain. Previous studies of theuse of aromatic ginger in treating musculoskeletal pain,including knee pain24,27,45,46 and muscle pain,47 reported thatginger produced moderate-to-large reductions in pain.24,47

Ginger was found to be as effective as indomethacin inrelieving symptoms of osteoarthritis with insignificant sideeffects.45 Comparing ginger with ibuprofen and a placebo inosteoarthritis, there was a statistically significant differencebetween the placebo, ginger and ibuprofen; the ranking ofefficacy of treatments was ibuprofen> ginger > placebo.27

These studies support the findings of this study concludingthat ginger has an analgesic and anti-inflammatory effect onmusculoskeletal pain. However, most of the previous stud-ies used ginger as an extract rather than aromatic oil; onlyone study used aromatic ginger oil combined with orangeessential oil46 and reported aroma-massage had potential asan alternative method for short-term knee pain relief. Noprevious study has tested using aromatic ginger oil for backpain reduction in an RCT.

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

The study found that 2% of aromatic ginger oil combinedwith ten 30-min sessions of Swedish massage was effectivefor older people with CLBP. Future studies may benefit from

trialling a higher concentrate of 3% to assess whether thisresults in larger effects at the short- and long-term.

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

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31

oth types of massage significantly improved participants’isability ratings from the level of moderate disability toinimal disability across the period of assessment, indi-

ating both short- and long-term effectiveness. However,he SMGO group improved significantly more in disabil-ty level than the TTM group. This result was in contrasto a previous study,20 which reported that clients in bothassage groups, reported improvements in disability mea-

urement, back performance and body flexibility, at allost-treatment assessment times. In Chatchawan et al.’study,20 TTM improved disability more than SM immediatelynd at the end of the three-week treatment; however, thereere no statistically significant differences on disability,ack performance and body flexibility. Previous studies41,43

hat compared Swedish massage with other types of massager treatments, including acupuncture massage, soft-tissueanipulation, exercise posture, education and sham laser

herapy (low-level infrared laser) on low back pain, foundhat Swedish massage significantly improved functional abil-ty both immediately after the massage session and in thehort-term (one month). In the current study, when aromaticinger oil was added to the Swedish-massage treatment, itas more effective than TTM for disability improvement in

he short- and long-term. The therapeutic benefit of aro-atic ginger oil may be particularly beneficial for disability;

owever, further studies should compare SMGO with SM withase oil as a placebo group to test this assumption. Vary-ng dosages of aroma-massage with ginger oil could also bexamined to see whether larger doses lead to greater effectsnd effects on other types of pain. Furthermore, researchersould use ginger in its different forms such as extract, aro-atic oil or herbal drink. In summary, the current study

oncludes that although both SMGO and TTM are effective ineducing pain, and improving disability across the period ofhort and long term, SMGO is more effective. The integrationf massage therapy for holistic health professional practiceor patients with CLBP in hospitals or aged-care facilitiesould be considered as a care option.

Limitations of the study are acknowledged and predom-nantly related to the study design. With the limitation ofunding and time for this PhD study, the research team made

decision to have two groups (treatment and control groups)o enable a bigger sample size in each group rather thandding a third placebo group. However, the Hrobjartsson andotzsche reviewed study (2004) found that placebo inter-entions in general did not have clinically important effects,ut that there were possible beneficial effects on patient-eported outcomes, especially pain.49 Although, the studyacked a placebo group, it still compared the treatmentntervention with a relevant control group and as such has aow risk of bias. Future studies should consider the additionf a placebo group.

onflict of interest

o conflict of interest is declared by the authors.

uthor contributions

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

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

cknowledgements

e thank the Centre for Health Practice Innovation (HPI),chool of Nursing and Midwifery Griffith University, Grif-th Graduate Research School and Christian University ofhailand for research support.

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