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1.  Massage Therapy vs. Simple Touch to Improve Pain and Mood in Patients with Advanced Cancer: A Randomized Trial 
Annals of internal medicine  2008;149(6):369-379.
BACKGROUND
Small studies of variable quality suggest that massage therapy may relieve pain and other symptoms.
OBJECTIVE
Evaluate efficacy of massage for decreasing pain and symptom distress and improving quality of life among persons with advanced cancer.
DESIGN
Multi-site randomized clinical trial.
SETTING
Population-based Palliative Care Research Network (PoPCRN).
PATIENTS
380 adults with advanced cancer experiencing moderate-severe pain; 90% were enrolled in hospice.
INTERVENTION
Six 30-minute massage or simple touch sessions over two weeks.
MEASUREMENTS
Primary outcomes were immediate (Memorial Pain Assessment Card, MPAC, 0 – 10 scale) and sustained (Brief Pain Inventory, BPI, 0 – 10 scales) change in pain. Secondary outcomes were immediate change in mood (MPAC 0 – 10 scale) and 60-second heart and respiratory rates and sustained change in quality of life (McGill Quality of Life Questionnaire, MQOL, 0 – 10 scale), symptom distress (Memorial Symptom Assessment Scale, MSAS, 0 – 4 scale), and analgesic medication use (parenteral morphine equivalents (milligrams/24 hours). Immediate outcomes were obtained just prior to and following each treatment session. Sustained outcomes were obtained at baseline and weekly for 3 weeks.
RESULTS
298 were included in the immediate outcome analysis and 348 in the sustained outcome analysis. 82 did not receive any allocated study treatments (37 massage, 45 control). Both groups demonstrated immediate improvement in pain (massage -1.87 points (CI, -2.07, -1.67), control -0.97 points (CI, -1.18, -0.76)) and mood (massage 1.58 points (CI, 1.40, 1.76), control 0.97 points (CI, 0.78, 1.16)). Massage was superior for both pain and mood (mean difference 0.90 and 0.61 points, respectively, P<0.001). There were no between group mean differences over time in pain (BPI Mean 0.07 (CI, -0.23, 0.37), BPI Worst -0.14 (CI, -0.59, 0.31)), quality of life (MQOL Overall 0.08 (CI, -0.37, 0.53)), symptom distress (MSAS Global Distress Index -0.002 (CI, -0.12, 0.12)), or analgesic medication use (parenteral morphine equivalents -0.10 (CI, -0.25, 0.05).
LIMITATIONS
The immediate outcome measures were obtained by unblinded study therapists, possibly leading to reporting bias and the overestimation of beneficial effect. The generalizability to all advanced cancer patients is uncertain. The differential beneficial effect of massage therapy over simple touch is not conclusive in the absence of a “usual care” control arm.
CONCLUSIONS
Massage may have immediately beneficial effects on pain and mood among patients with advanced cancer. Given the lack of sustained effects and the observed improvements in both study arms, the potential benefits of attention and simple touch should also be considered in this population.
PMCID: PMC2631433  PMID: 18794556
2.  The immediate effect of traditional Malay massage on substance P, inflammatory mediators, pain scale and functional outcome among patients with low back pain: study protocol of a randomised controlled trial 
Background
The treatment of low back pain is very challenging due to the recurrent nature of the problem. It is believed that traditional Malay massage helps to relieve such back pain but there is a lack of scientific evidence to support both the practice of traditional Malay massage and the mechanism by which it exerts its effect. The aim of this study is to investigate the immediate effect of traditional Malay massage on the pain scale, substance P, inflammatory mediators, and functional outcomes among low back pain patients.
Methods
A non-blinded, randomised controlled trial will be conducted. A total of sixty-six patients who fulfil the inclusion criteria will be recruited. The participants will be randomly allocated into intervention (traditional Malay massage) and control (relaxation position) groups. Blood and saliva samples will be collected before and immediately after intervention. All collected samples will be analysed. The primary outcomes are the changes in the level of substance P in both saliva and blood samples between both groups. The secondary outcomes include the levels of inflammatory mediators [i.e. TNF-α, IL-1β, IL-8, monocyte chemotactic protein-1, IL-6 and IL-10, and the soluble form of the intercellular adhesion molecule], the pain intensity as measured by a visual analogous scale and functional outcomes using the Roland-Morris Disability Questionnaire.
Discussion
Massage is a type of physical therapy that has been proven to be potentially capable of reducing unpleasant pain sensations by a complex sensory response and chemical mediators such as substance P and various inflammatory mediators. Previous studies conducted using Thai, Swedish, or other forms of massage therapies, have showed inconsistent findings on substance P levels pre and post the interventions. Each massage genre varies in terms of massage and joint mobilization points, as well as the lumbar spinous process. Traditional Malay massage, known locally as “Urut Melayu”, involves soft-tissue manipulation of the whole body applied using the hands and fingers. This massage technique combines both deep muscular tissue massage and spiritual rituals. This trial is expected to give rise to new knowledge underlying the mechanisms for pain and inflammation relief that are activated by traditional Malay massage.
Trial registration
Australian New Zealand Clinical Trials ACTRN12615000537550.
doi:10.1186/s12906-016-0988-1
PMCID: PMC4714433  PMID: 26767971
Low back pain; Massage; Substance P; Visual analogue pain scale; East Asian traditional medicine
3.  Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial 
BACKGROUND: The effectiveness of massage therapy for low-back pain has not been documented. This randomized controlled trial compared comprehensive massage therapy (soft-tissue manipulation, remedial exercise and posture education), 2 components of massage therapy and placebo in the treatment of subacute (between 1 week and 8 months) low-back pain. METHODS: Subjects with subacute low-back pain were randomly assigned to 1 of 4 groups: comprehensive massage therapy (n = 25), soft-tissue manipulation only (n = 25), remedial exercise with posture education only (n = 22) or a placebo of sham laser therapy (n = 26). Each subject received 6 treatments within approximately 1 month. Outcome measures obtained at baseline, after treatment and at 1-month follow-up consisted of the Roland Disability Questionnaire (RDQ), the McGill Pain Questionnaire (PPI and PRI), the State Anxiety Index and the Modified Schober test (lumbar range of motion). RESULTS: Of the 107 subjects who passed screening, 98 (92%) completed post-treatment tests and 91 (85%) completed follow-up tests. Statistically significant differences were noted after treatment and at follow-up. The comprehensive massage therapy group had improved function (mean RDQ score 1.54 v. 2.86-6.5, p < 0.001), less intense pain (mean PPI score 0.42 v. 1.18-1.75, p < 0.001) and a decrease in the quality of pain (mean PRI score 2.29 v. 4.55-7.71, p = 0.006) compared with the other 3 groups. Clinical significance was evident for the comprehensive massage therapy group and the soft-tissue manipulation group on the measure of function. At 1-month follow-up 63% of subjects in the comprehensive massage therapy group reported no pain as compared with 27% of the soft-tissue manipulation group, 14% of the remedial exercise group and 0% of the sham laser therapy group. INTERPRETATION: Patients with subacute low-back pain were shown to benefit from massage therapy, as regulated by the College of Massage Therapists of Ontario and delivered by experienced massage therapists.
PMCID: PMC1231369  PMID: 10906914
4.  The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol 
JMIR Research Protocols  2016;5(4):e203.
Background
Postoperative pain is common in the intensive care unit despite the administration of analgesia. Some trials suggest that massage can be effective at reducing postoperative pain in acute care units; however, its effects on pain relief in the intensive care unit and when pain severity is highest remain unknown.
Objective
The objective is to evaluate the effectiveness of hand massage on the pain intensity (primary outcome), unpleasantness and interference, muscle tension, anxiety, and vital signs of critically ill patients after cardiac surgery.
Methods
A 3-arm randomized controlled trial will be conducted. A total of 79 patients who are 18 years or older, able to speak French or English and self-report symptoms, have undergone elective cardiac surgery, and do not have a high risk of postoperative complications and contraindications to hand massage will be recruited. They will be randomly allocated (1:1:1) to standard care plus either 3 20-minute hand massages (experimental), 3 20-minute hand holdings (active control), or 3 20-minute rest periods (passive control). Pain intensity, unpleasantness, anxiety, muscle tension, and vital signs will be evaluated before, immediately after, and 30 minutes later for each intervention administered within 24 hours postoperatively. Peer-reviewed competitive funding was received from the Quebec Nursing Intervention Research Network and McGill University in December 2015, and research ethics approval was obtained February 2016.
Results
Recruitment started in April 2016, and data collection is expected to be complete by January 2017. To date, 24 patients were randomized and had data collection done.
Conclusions
This study will be one of the first randomized controlled trials to examine the effect of hand massage on the pain levels of critically ill patients after cardiac surgery and to provide empirical evidence for the use of massage among this population.
ClinicalTrial
ClinicalTrials.gov NCT02679534; https://clinicaltrials.gov/ct2/show/NCT02679534 (Archived by WebCite at http://www.webcitation.org/6l8Ly5eHS)
doi:10.2196/resprot.6277
PMCID: PMC5118583  PMID: 27821384
massage; pain; critical care; randomized controlled trial; anxiety; muscle tension; vital signs; clinical protocol; complementary therapies; thoracic surgery
5.  Randomised trial of acupuncture compared with conventional massage and “sham” laser acupuncture for treatment of chronic neck pain 
BMJ : British Medical Journal  2001;322(7302):1574.
Objectives
To compare the efficacy of acupuncture and conventional massage for the treatment of chronic neck pain.
Design
Prospective, randomised, placebo controlled trial.
Setting
Three outpatient departments in Germany.
Participants
177 patients aged 18-85 years with chronic neck pain.
Interventions
Patients were randomly allocated to five treatments over three weeks with acupuncture (56), massage (60), or “sham” laser acupuncture (61).
Main outcome measures
Primary outcome measure: maximum pain related to motion (visual analogue scale) irrespective of direction of movement one week after treatment. Secondary outcome measures: range of motion (3D ultrasound real time motion analyser), pain related to movement in six directions (visual analogue scale), pressure pain threshold (pressure algometer), changes of spontaneous pain, motion related pain, global complaints (seven point scale), and quality of life (SF-36). Assessments were performed before, during, and one week and three months after treatment. Patients' beliefs in treatment were assessed.
Results
One week after five treatments the acupuncture group showed a significantly greater improvement in motion related pain compared with massage (difference 24.22 (95% confidence interval 16.5 to 31.9), P=0.0052) but not compared with sham laser (17.28 (10.0 to 24.6), P=0.327). Differences between acupuncture and massage or sham laser were greater in the subgroup who had had pain for longer than five years (n=75) and in patients with myofascial pain syndrome (n=129). The acupuncture group had the best results in most secondary outcome measures. There were no differences in patients' beliefs in treatment.
Conclusions
Acupuncture is an effective short term treatment for patients with chronic neck pain, but there is only limited evidence for long term effects after five treatments.
What is already known on this topicAcupuncture is a widespread complementary treatmentEvidence from trials have given conflicting results on its use in the treatment of neck pain because of methodological shortcomings and because effects were compared either with alternative treatments or with different sham procedures imitating acupuncture, but not bothWhat this study addsCompared with sham laser acupuncture and massage, needle acupuncture has beneficial effects on mobility and pain related to motion in patients with chronic neck painAcupuncture was clearly more effective than massage, but differences were not always significant compared with sham laser acupunctureAcupuncture was the best treatment for patients with the myofascial syndrome and those who had had pain for longer than five years
PMCID: PMC33515  PMID: 11431299
6.  Massage Impact on Pain in Opioid-dependent Patients in Substance Use Treatment 
Background:
Chronic pain is a common cause of health care utilization and high levels of pain are pronounced in individuals engaged in methadone maintenance treatment. Although massage has been demonstrated to alleviate chronic pain symptoms, its use as an adjunctive therapy to modify pain during opioid-replacement treatment is absent from the literature.
Purpose:
To consider the efficacy of Swedish massage in reducing pain in opioid-dependent patients with chronic pain receiving methadone treatment.
Setting:
Trial was conducted at a nonprofit methadone treatment center serving low-income patients.
Research Design:
A randomized clinical trial with randomized to either 1) massage plus treatment-as-usual (TAU) (n = 27) or 2) TAU (n = 24). Durability of treatment effect was evaluated at Week 12.
Intervention:
Eight weekly 50-minute Swedish massage sessions plus TAU or TAU alone.
Main Outcome Measures:
Pain, anxiety, depression, physical functioning, decreased substance use, and improvement in treatment engagement.
Results:
Randomized participants were comparable at Baseline for demographic, pain, physical, and emotional variables. Massage group reported improved pain scores; worst pain had a clinically significant 2-point improvement while the other pain scores did not. Overall improvements were not observed in treatment engagement or levels of anxiety, depression, or physical functioning. A subgroup of the participants, who felt they could be pain-free, consistently reported improvements in pain from Baseline to Week 8, and this was most pronounced and clinically significant in the massage group.
Conclusions:
These preliminary findings do not support an overall clinically significant positive effect of Swedish massage on reduction in pain ratings or improvement in anxiety, depression, or treatment engagement in a substance-using, opioid-dependent population with chronic pain. Future nonpharmacologic pain research in marginalized substance-using populations may wish to consider some of the challenges and limitations faced in this project.
PMCID: PMC4353208  PMID: 25780471
massage; pain; opioid dependence; substance use; self-efficacy; methadone
7.  Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial 
Trials  2014;15:418.
Background
Low back pain is a common, disabling musculoskeletal disorder in both developing and developed countries. Although often recommended, the potential efficacy of massage therapy in general, and Chinese massage (tuina) in particular, for relief of chronic low back pain (CLBP) has not been fully established due to inadequate sample sizes, low methodological quality, and subclinical dosing regimens of trials to date. Thus, the purpose of this randomized controlled trial (RCT) is to evaluate the comparative effectiveness of tuina massage therapy versus conventional analgesics for CLBP.
Methods/Design
The present study is a single center, two-arm, open-label RCT. A total of 150 eligible CLBP patients will be randomly assigned to either a tuina treatment group or a conventional drug control group in a 1:1 ratio. Patients in the tuina group receive a 20 minutes, 4-step treatment protocol which includes both structural and relaxation massage, administered in 20 sessions over a period of 4 weeks. Patients in the conventional drug control group are instructed to take a specific daily dose of ibuprofen. The primary outcome measure is the change from baseline back pain and function, measured by Roland-Morris Disability Questionnaire, at two months. Secondary outcome measures include the visual analogue scale, Japanese orthopedic association score (JOAS), and McGill pain questionnaire.
Discussion
The design and methodological rigor of this trial will allow for collection of valuable data to evaluate the efficacy of a specific tuina protocol for treating CLBP. This trial will therefore contribute to providing a solid foundation for clinical treatment of CLBP, as well as future research in massage therapy.
Trial registration
This trial was registered with ClinicalTrials.gov of the National Institute of Health on 22 October 2013 (http://NCT01973010).
doi:10.1186/1745-6215-15-418
PMCID: PMC4228121  PMID: 25352050
Chronic low back pain; Effectiveness; Randomized controlled trial; Tuina; Chinese massage therapy
8.  Touch and Massage for Medically Fragile Infants 
Research investigating the efficacy of infant massage has largely focused on premature and low birth weight infants. The majority of investigations have neglected highly acute patients in academic neonatal intensive care units (NICUs). The current study was developed with two aims: (Phase 1) to develop, implement and demonstrate the feasibility and safety of a parent-trained compassionate touch/massage program for infants with complex medical conditions and (Phase 2) to conduct a longitudinal randomized control trial (RCT) of hand containment/massage versus standard of care in a level III academic Center for Newborn and Infant Critical Care (CNICC). Certified infant massage instructors (CIMIs) taught parents to massage their hospitalized infants. Massage therapy and instruction were performed for seven consecutive days and health outcomes were collected for up to 1 month following treatment. Caregivers, nurses and certified infant massage therapists indicated moderate to high levels of satisfaction and feasibility with the implementation of hand containment/massage in a level III academic center CNICC. In addition, infant behavioral and physiological measures were within safe limits during the massage sessions. All caregivers participating in the massage group reported high levels of satisfaction 7 days into the intervention and at the 1-month follow-up with regards to their relationship with their infant, the massage program's impact on that relationship and the massage program. Due to unequal and small sample sizes, between group analyses (control versus massage) were not conducted. Descriptive infant characteristics of health outcomes are described. Preliminary data from this study indicates feasibility and safety of infant massage and satisfaction among the caregivers, CIMIs and the nurses in the CNICC. An important contribution from this study was the demonstration of the infants’ safety based on physiological stability and no change in agitation/pain scores of the infants receiving massage. Massage in a tertiary urban academic NICU continues to be an area of needed study. Future studies examining infant health outcomes, such as weight gain, decreased length of hospitalization and caregiver–infant bonding, would provide greater insight into the impact of massage for medically fragile infants.
doi:10.1093/ecam/nem076
PMCID: PMC2781772  PMID: 18955228
medically fragile; infant massage; neonatal intensive care; caregiver depression; pediatric psychology; CAM; integrative medicine
9.  Changes in Clinical Parameters in Patients with Tension-type Headache Following Massage Therapy: A Pilot Study 
Complementary and alternative medicine approaches to treatment for tension-type headache are increasingly popular among patients, but evidence supporting its efficacy is limited. The objective of this study was to assess short term changes on primary and secondary headache pain measures in patients with tension-type headache (TTH) receiving a structured massage therapy program with a focus on myofascial trigger point therapy. Participants were enrolled in an open label trial using a baseline control with four 3-week phases: baseline, massage (two 3-week phases) and follow-up. Twice weekly, 45-minute massage sessions commenced following the baseline phase. A daily headache diary was maintained throughout the study in which participants recorded headache incidence, intensity, and duration. The Headache Disability Index was administered upon study entry and at 3-week intervals thereafter. 18 subjects were enrolled with 16 completing all headache diary, evaluation, and massage assignments. Study participants reported a median of 7.5 years with TTH. Headache frequency decreased from 4.7±0.7 episodes per week during baseline to 3.7±0.9 during treatment period 2 (P<0.001); reduction was also noted during the follow-up phase (3.2±1.0). Secondary measures of headache also decreased across the study phases with headache intensity decreasing by 30% (P<0.01) and headache duration from 4.0±1.3 to 2.8±0.5 hours (P<0.05). A corresponding improvement in Headache Disability Index was found with massage (P<0.001). This pilot study provides preliminary evidence for reduction in headache pain and disability with massage therapy that targets myofascial trigger points, suggesting the need for more rigorously controlled studies.
PMCID: PMC2565109  PMID: 19119396
Complementary and Alternative Medicine; Headache Disability Index; Manual Therapy; Myofasical Pain; Myofascial Trigger Points
10.  Myofascial trigger point-focused head and neck massage for recurrent tension-type headache: A randomized, placebo-controlled clinical trial 
The Clinical journal of pain  2015;31(2):159-168.
Objective
Myofascial trigger points (MTrPs) are focal disruptions in skeletal muscle that can refer pain to the head and reproduce the pain patterns of tension-type headache (TTH). The present study applied massage focused on MTrPs of subjects with TTH in a placebo-controlled, clinical trial to assess efficacy on reducing headache pain.
Methods
Fifty-six subjects with TTH were randomized to receive 12 massage or placebo (detuned ultrasound) sessions over six weeks, or to wait-list. Trigger point release (TPR) massage focused on MTrPs in cervical musculature. Headache pain (frequency, intensity and duration) was recorded in a daily headache diary. Additional outcome measures included self-report of perceived clinical change in headache pain and pressure-pain threshold (PPT) at MTrPs in the upper trapezius and sub-occipital muscles.
Results
From diary recordings, group differences across time were detected in headache frequency (p=0.026), but not for intensity or duration. Post hoc analysis indicated headache frequency decreased from baseline for both massage (p<0.0003) and placebo (p=0.013), but no difference was detected between massage and placebo. Subject report of perceived clinical change was a greater reduction in headache pain for massage than placebo or wait-list groups (p=0.002). PPT improved in all muscles tested for massage only (all p's<0.002).
Discussion
Two findings from this study are apparent: 1) MTrPs are important components in the treatment of TTH, and 2) TTH, like other chronic conditions, is responsive to placebo. Clinical trials on headache that do not include a placebo group are at risk for overestimating the specific contribution from the active intervention.
doi:10.1097/AJP.0000000000000091
PMCID: PMC4286457  PMID: 25329141
Episodic tension-type headache; chronic tension-type headache; complementary medicine; headache frequency; algometer
11.  Randomized Trial of Therapeutic Massage for Chronic Neck Pain 
The Clinical journal of pain  2009;25(3):233-238.
Objectives
Little is known about the effectiveness of therapeutic massage, one of the most popular complementary medical treatments for neck pain. A randomized controlled trial was conducted to evaluate whether therapeutic massage is more beneficial than a self-care book for patients with chronic neck pain.
Methods
Sixty-four such patients were randomized to receive up to 10 massages over 10 weeks or a self-care book. Follow-up telephone interviews after 4, 10, and 26 weeks assessed outcomes including dysfunction and symptoms. Log-binomial regression was used to assess whether there were differences in the percentages of participants with clinically meaningful improvements in dysfunction and symptoms (i.e., > 5 point improvement on the Neck Disability Index (NDI); > 30% improvement from baseline on the symptom bothersomeness scale) at each time point.
Results
At 10 weeks, more participants randomized to massage experienced clinically significant improvement on the NDI (39% vs. 14% of book group; RR= 2.7; 95% confidence interval (CI) = 0.99–7.5) and on the symptom bothersomeness scale (55% vs. 25% of book group; RR=2.2; 95% CI=1.04–4.2). After 26 weeks, massage group members tended to be more likely to report improved function (RR=1.8; 95% CI=0.97–3.5), but not symptom bothersomeness (RR=1.1; 95% CI=0.6–2.0). Mean differences between groups were strongest at 4 weeks and not evident by 26 weeks. No serious adverse experiences were reported.
Conclusions
This study suggests that massage is safe and may have clinical benefits for treating chronic neck pain at least in the short term. A larger trial is warranted to confirm these results.
doi:10.1097/AJP.0b013e31818b7912
PMCID: PMC2664516  PMID: 19333174
12.  Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain 
The BMJ  2008;337:a884.
Objective To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain.
Design Factorial randomised trial.
Setting 64 general practices in England.
Participants 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription.
Interventions Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling.
Main outcome measures Roland Morris disability score (number of activities impaired by pain) and number of days in pain.
Results Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported.
Conclusions One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.
Trial registration National Research Register N0028108728.
doi:10.1136/bmj.a884
PMCID: PMC3272681  PMID: 18713809
13.  Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain 
Objective To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain.
Design Factorial randomised trial.
Setting 64 general practices in England.
Participants 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription.
Interventions Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling.
Main outcome measures Roland Morris disability score (number of activities impaired by pain) and number of days in pain.
Results Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported.
Conclusions One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.
Trial registration National Research Register N0028108728.
doi:10.1136/bmj.a884
PMCID: PMC3272681  PMID: 18713809
14.  Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes 
Background Context
This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of non-pharmacological treatments.
Purpose
To determine the optimal dose of massage for neck pain.
Study Design/Setting
Two-phase randomized trial for persons with chronic non-specific neck pain. Primary randomization to one of 5 groups receiving 4 weeks of massage (30 minutes 2×/ or 3×/week or 60 minutes 1×, 2×, or 3×/week). Booster randomization of participants to receive an additional 6 massages, 60 minute 1×/week, or no additional massage.
Patient Sample
179 participants from Group Health and the general population of Seattle, WA USA recruited between June 2010 and August 2011.
Outcome Measures
Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0–10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as >5 point decrease in dysfunction and > 30% decrease in pain from baseline.
Methods
Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations. Secondary analyses for the continuous outcomes used linear generalized estimating equations. This study was funded the National Center for Complementary and Alternative Medicine, NIH, USA (R01 AT004411). The funders had no role in the interpretation or reporting of results.
Results
There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: RR=1.56(1.08–2.25), P=0.018; pain: RR=1.25(0.98–1.61); P=0.077), but those were non-significant at 26 weeks (dysfunction: RR=1.22(0.85–1.74); pain: RR=1.09(0.82–1.43)). Subgroup analysis by primary and booster treatments found the booster dose only effective amongst those initially randomized to one of the 60 minutes massage groups.
Conclusions
“Booster” doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain.
doi:10.1016/j.spinee.2015.06.049
PMCID: PMC4596391  PMID: 26096474
chronic neck pain; dosing; massage; randomized clinical trial; complementary medicine; clinical trial methods
15.  Effects of traditional Thai self-massage using a Wilai massage stickTM versus ibuprofen in patients with upper back pain associated with myofascial trigger points: a randomized controlled trial 
Journal of Physical Therapy Science  2015;27(11):3493-3497.
[Purpose] The aim of this study was to examine the effects of traditional Thai self-massage using a Wilai massage stickTM versus ibuprofen on reducing upper back pain associated with myofascial trigger points. [Subjects and Methods] Sixty patients who were diagnosed as having upper back pain associated with myofascial trigger points were randomly allocated to either a massage group using a Wilai massage stickTM or a medication group taking ibuprofen for 5 days. Both groups were advised to perform the same daily stretching exercise program. Pain intensity, pressure pain threshold, tissue hardness, and cervical range of motion were assessed at baseline, immediately after the first treatment session, and on the fifth day after the last treatment session. [Results] The massage group had significant improvement in all parameters at all assessment time points. Similar changes were observed in the medication group except for the pressure pain threshold and tissue hardness. The adjusted post-test mean values for each assessment time point were significantly better in the massage group than in the medication group. [Conclusion] Tradition Thai self-massage using a Wilai massage stickTM provides better results than taking ibuprofen for patients who have upper back pain associated with myofascial trigger points. It could be an alternative treatment for this patient population.
doi:10.1589/jpts.27.3493
PMCID: PMC4681931  PMID: 26696724
Massage; Massage stick; Trigger points
16.  Changes in Psychological Parameters in Patients with Tension-type Headache Following Massage Therapy: A Pilot Study 
Investigations into complementary and alternative medicine (CAM) approaches to address stress, depression, and anxiety of those experiencing chronic pain are rare. The objective of this pilot study was to assess the value of a structured massage therapy program, with a focus on myofascial trigger points, on psychological measures associated with tension-type headache. Participants were enrolled in an open-label trial using a baseline control with four 3-week phases: baseline, massage (two 3-week periods) and a follow-up phase. Eighteen subjects with episodic or chronic tension-type headache were enrolled and evaluated at 3-week intervals using the State-Trait Anxiety Inventory, Beck Depression Inventory, and the Perceived Stress Scale. The Daily Stress Inventory was administered over 7-day periods during baseline and the final week of massage. Twice weekly, 45-minute massage therapy sessions commenced following the baseline phase and continued for 6 weeks. A significant improvement in all psychological measures was detected over the timeframe of the study. Post hoc evaluation indicated improvement over baseline for depression and trait anxiety following 6 weeks of massage, but not 3 weeks. A reduction in the number of events deemed stressful as well as their respective impact was detected. This pilot study provides evidence for reduction of affective distress in a chronic pain population, suggesting the need for more rigorously controlled studies using massage therapy to address psychological measures associated with TTH.
PMCID: PMC2700492  PMID: 20046550
Beck Depression Inventory; Complementary and Alternative Medicine; Daily Stress Inventory; Myofascial Pain; State-Trait Anxiety Inventory
17.  Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial 
Background
Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low “doses” of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment.
Methods/design
In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks.
Discussion
A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued.
Trial registration
This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836
doi:10.1186/1472-6882-12-158
PMCID: PMC3546891  PMID: 22985134
Therapeutic massage; Optimal dose; Chronic neck pain
18.  Short-term effects of vacuum massage on epidermal and dermal thickness and density in burn scars: an experimental study 
Burns & Trauma  2016;4:27.
Background
Vacuum massage is a non-invasive mechanical massage technique invented to treat burns and scars. To date, no effects of vacuum massage on thickness and density of human scar tissue have been reported. The process in which external stimuli are converted into biochemical responses in the cell is known as mechanotransduction. In the skin endothelial cells, fibroblasts and myofibroblasts embedded in the extracellular matrix (ECM) sense mechanical stimuli (created by vacuum massage) and may promote intracellular processes leading to matrix remodelling. Since mechanotransduction could be a plausible working mechanism for vacuum massage as an anti-scarring therapy, this study aims to investigate the short-term effects of vacuum massage on thickness and density of epidermis and dermis in burn scars in order to find proof of ECM remodelling.
Methods
A one group experimental study was performed. Patients with burn scars on upper extremities, lower extremities, and trunk were recruited for participation in this study. The DUB®cutis 22 MHz ultrasound scanner was used to assess thickness and density of the epidermal and dermal skin layers. After baseline measurements, vacuum massage was performed according to a pre-defined protocol. Measurements were carried out at 5 min, 30 min, 1 h, and 2 h post-intervention.
Results
Thirteen scar sites from 9 different patients were investigated. In 8 out of the 13 scar sites, a disruption of the epidermis was noticed after the vacuum massage. Five minutes after the intervention, epidermal density decreased statistically significantly (p = .022) and dermal thickness increased (p = .018). Both changes lasted for more than 1 h, but after 2 h, the changes were no longer statistically significant. Dermal density decreased significantly (p = .048) immediately after the intervention, and this decrease was still present after 2 h (p = .011).
Conclusions
Preliminary results show that the disruption of the epidermis may indicate that vacuum massage could be able to actually breach the skin barrier. The statistically significant changes in the dermal layers could suggest an increased ECM production after vacuum massage.
doi:10.1186/s41038-016-0052-x
PMCID: PMC4964043  PMID: 27574695
Burn; Scars; Vacuum massage; Dermal thickness; Dermal density
19.  The effect of foot massage on long-term care staff working with older people with dementia: a pilot, parallel group, randomized controlled trial 
BMC Nursing  2013;12:5.
Background
Caring for a person with dementia can be physically and emotionally demanding, with many long-term care facility staff experiencing increased levels of stress and burnout. Massage has been shown to be one way in which nurses’ stress can be reduced. However, no research has been conducted to explore its effectiveness for care staff working with older people with dementia in long-term care facilities.
Methods
This was a pilot, parallel group, randomized controlled trial aimed at exploring feasibility for a larger randomized controlled trial. Nineteen staff, providing direct care to residents with dementia and regularly working ≥ two day-shifts a week, from one long-term care facility in Queensland (Australia), were randomized into either a foot massage intervention (n=9) or a silent resting control (n=10). Each respective session lasted for 10-min, and participants could receive up to three sessions a week, during their allocated shift, over four-weeks. At pre- and post-intervention, participants were assessed on self-report outcome measures that rated mood state and experiences of working with people with dementia. Immediately before and after each intervention/control session, participants had their blood pressure and anxiety measured. An Intention To Treat framework was applied to the analyses. Individual qualitative interviews were also undertaken to explore participants’ perceptions of the intervention.
Results
The results indicate the feasibility of undertaking such a study in terms of: recruitment; the intervention; timing of intervention; and completion rates. A change in the intervention indicated the importance of a quiet, restful environment when undertaking a relaxation intervention. For the psychological measures, although there were trends indicating improvement in mood there was no significant difference between groups when comparing their pre- and post- scores. There were significant differences between groups for diastolic blood pressure (p= 0.04, partial η2=0.22) and anxiety (p= 0.02, partial η2=0.31), with the foot massage group experiencing greatest decreases immediately after the session. The qualitative interviews suggest the foot massage was well tolerated and although taking staff away from their work resulted in some participants feeling guilty about taking time out, a 10-min foot massage was feasible during a working shift.
Conclusions
This pilot trial provides data to support the feasibility of the study in terms of recruitment and consent, the intervention and completion rates. Although the outcome data should be treated with caution, the pilot demonstrated the foot massage intervention showed trends in improved mood, reduced anxiety and lower blood pressure in long-term care staff working with older people with dementia. A larger study is needed to build on these promising, but preliminary, findings.
Trial registration
ACTRN: ACTRN12612000659808.
doi:10.1186/1472-6955-12-5
PMCID: PMC3598869  PMID: 23414448
Anxiety; Blood pressure; Care staff; Complementary and alternative medicine; Dementia; Long-term care; Massage; Mood state; Pilot; Randomized controlled trial
20.  Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial 
Trials  2009;10:96.
Background
Chronic back pain is a major public health problem and the primary reason patients seek massage treatment. Despite the growing use of massage for chronic low back pain, there have been few studies of its effectiveness. This trial will be the first evaluation of the effectiveness of relaxation massage for chronic back pain and the first large trial of a focused structural form of massage for this condition.
Methods and Design
A total of 399 participants (133 in each of three arms) between the ages of 20 and 65 years of age who have low back pain lasting at least 3 months will be recruited from an integrated health care delivery system. They will be randomized to one of two types of massage ("focused structural massage" or "relaxation massage"), or continued usual medical care. Ten massage treatments will be provided over 10 weeks. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline and after 10, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, perceived stress, and use and costs of healthcare services for back pain will also be measured. Outcomes across assigned treatment groups will be compared using generalized estimating equations, accounting for participant correlation and adjusted for baseline value, age, and sex. For both primary outcome measures, this trial will have at least 85% power to detect the presence of a minimal clinically significant difference among the three treatment groups and 91% power for pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount.
Conclusion
Results of this trial will help clarify the value of two types of massage therapy for chronic low back pain.
Trial registration
Clinical Trials.gov NCT 00371384.
doi:10.1186/1745-6215-10-96
PMCID: PMC2774684  PMID: 19843340
21.  Hypnosis can reduce pain in hospitalized older patients: a randomized controlled study 
BMC Geriatrics  2016;16:14.
Background
Chronic pain is a common and serious health problem in older patients. Treatment often includes non pharmacological approaches despite a relatively modest evidence base in this population. Hypnosis has been used in younger adults with positive results. The main objective of this study was to measure the feasibility and efficacy of hypnosis (including self hypnosis) in the management of chronic pain in older hospitalized patients.
Methods
A single center randomized controlled trial using a two arm parallel group design (hypnosis versus massage). Inclusion criteria were chronic pain for more than 3 months with impact on daily life activities, intensity of > 4; adapted analgesic treatment; no cognitive impairment. Brief pain inventory was completed.
Results
Fifty-three patients were included (mean age: 80.6 ± 8.2- 14 men; 26 hypnosis; 27 massage. Pain intensity decreased significantly in both groups after each session. Average pain measured by the brief pain index sustained a greater decrease in the hypnosis group compared to the massage group during the hospitalisation. This was confirmed by the measure of intensity of the pain before each session that decreased only in the hypnosis group over time (P = 0.008). Depression scores improved significantly over the time only in the hypnosis group (P = 0.049). There was no effect in either group 3 months post hospitals discharge.
Discussions and conclusion
Hypnosis represents a safe and valuable tool in chronic pain management of hospitalized older patients. In hospital interventions did not provide long term post discharge relief.
Trial registration
ISRCTN15615614; registered 2/1/2015.
doi:10.1186/s12877-016-0180-y
PMCID: PMC4714456  PMID: 26767506
Hypnosis; chronic pain; older patients
22.  SPECIFIC AND CROSS OVER EFFECTS OF MASSAGE FOR MUSCLE SORENESS: RANDOMIZED CONTROLLED TRIAL 
Purpose/Background:
Muscle soreness can negatively interfere with the activities of daily living as well as sports performance. In the working environment, a common problem is muscle tenderness, soreness and pain, especially for workers frequently exposed to unilateral high repetitive movements tasks. The aim of the study is therefore to investigate the acute effect of massage applied using a simple device Thera‐band roller Massager on laboratory induced hamstring muscle soreness, and the potential cross over effect to the non‐massaged limb.
Methods:
22 healthy untrained men (Mean age 34 +/− 7 years; mean height 181.7 +/− 6.9 cm; mean weight 80.6 +/− 6.4 kg; BMI: 24.5 +/− 1.3) with no prior history of knee, low back or neck injury or other adverse health issues were recruited. Participants visited the researchers on two separate occasions, separated by 48 hours, each time providing a soreness rating (modified visual analog scale 0‐10), and being tested for pressure pain threshold (PPT) and active range of motion (ROM) of the hamstring muscles. During the first visit, delayed onset muscular soreness of the hamstring muscles was induced by 10 x 10 repetitions of the stiff‐legged dead‐lift. On the second visit participants received either 1) 10 minutes of roller massage on one leg, while the contralateral leg served as a cross over control, or 2) Resting for 10 minutes with no massage at all. Measurement of soreness, PPT and ROM were taken immediately before and at 0, 10, 30 and 60 min. after treatment.
Results:
There was a significant group by time interaction for soreness (p < 0.0001) and PPT (p = 0.0007), with the massage group experiencing reduced soreness and increasing PPT compared with the control group. There was no group by time interaction for ROM (p = 0.18). At 10 min. post massage there was a significant reduction in soreness of the non‐massaged limb in the cross over control group compared to controls but this effect was lost 30 minutes post massage.
Conclusion:
Massage with a roller device reduces muscle soreness and is accompanied by a higher PPT of the affected muscle.
Level of Evidence:
2c; outcomes research
PMCID: PMC3924612  PMID: 24567859
Cross over effect; delayed onset muscle soreness hyperalgesia; pain
23.  A Pilot Feasibility Study of Massage to Reduce Pain in People with Spinal Cord Injury during Acute Rehabilitation 
Spinal cord  2013;51(11):847-851.
Objective
To determine the feasibility of conducting a randomized controlled trial of massage therapy for patients with new spinal cord injury (SCI) during acute inpatient rehabilitation.
Design
A pilot single-center, randomized, single-blind, cross-over clinical trial.
Setting
Free-standing, not-for-profit, comprehensive rehabilitation center specializing in SCI rehabilitation
Participants
Forty adults ages 18 years and older undergoing acute rehabilitation following spinal cord injury reporting any type of pain.
Intervention
Rehabilitation nurses trained to give broad compression massage (BCM) and a control light contact touch (LCT) treatments. Participants were randomized to receive either BCM or LCT first, in six 20 minute treatment sessions over two weeks, with a one week wash-out between the two-week treatment periods.
Main Outcome Measures
Primary outcomes were changes in pain intensity and in fatigue, measured daily. Secondary outcomes included depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) and an assessment of pain medication usage.
Results
Pain intensity was higher at baseline and reduced more in the LCT-first group compared to the BCM-first group in period 1 (p=0.014); although this pattern was not found in period 2 (p=0.58). LCT and BCM groups did not significantly differ on any secondary measures except PHQ-9.
Conclusions
This study demonstrates the feasibility of using rehabilitation nurses to provide tactile therapy to patients with SCI and suggests a model for controlled clinical trials examining the efficacy of massage therapies. While efficacy was difficult to assess, broad compression massage was safe and well tolerated.
doi:10.1038/sc.2013.104
PMCID: PMC3815956  PMID: 24042991
spinal cord injury; massage; randomized clinical trial
24.  Evaluating the Influence of Massage on Leg Strength, Swelling, and Pain Following a Half-Marathon 
Journal of Sports Science & Medicine  2004;3(YISI 1):37-43.
Massage therapy is commonly used following endurance running races with the expectation that it will enhance post-run recovery of muscle function and reduce soreness. A limited number of studies have reported little or no influence of massage therapy on post-exercise muscle recovery. However, no studies have been conducted in a field setting to assess the potential for massage to influence muscle recovery following an actual endurance running race. To evaluate the potential for repeated massage therapy interventions to influence recovery of quadriceps and hamstring muscle soreness, recovery of quadriceps and hamstring muscle strength and reduction of upper leg muscle swelling over a two week recovery period following an actual road running race. Twelve adult recreational runners (8 male, 4 female) completed a half marathon (21.1 km) road race. On days 1,4, 8, and 11 post-race, subjects received 30 minutes of standardized massage therapy performed by a registered massage therapist on a randomly assigned massage treatment leg, while the other (control) leg received no massage treatment. Two days prior to the race (baseline) and preceding the treatments on post-race days 1, 4, 8, and 11 the following measures were conducted on each of the massage and control legs: strength of quadriceps and hamstring muscles, leg swelling, and soreness perception. At day 1, post-race quadriceps peak torque was significantly reduced (p < 0.05), and soreness and leg circumference significantly elevated (p < 0.05) relative to pre-race values with no difference between legs. This suggested that exercise-induced muscle disruption did occur. Comparing the rate of return to baseline measures between the massaged and control legs, revealed no significant differences (p > 0.05). All measures had returned to baseline at day 11. Massage did not affect the recovery of muscles in terms of physiological measures of strength, swelling, or soreness. However, questionnaires revealed that 7 of the 12 participants perceived that the massaged leg felt better upon recovery.
Key PointsMassage does not appear to affect physiological indices of muscle recovery post exercise.Massage does appear to positively influence perceptions of recovery.More research needs to be completed on the purported benefits of massage.
PMCID: PMC3990931  PMID: 24778552
Recovery; running; perception; massage
25.  A Comparison of the Effects of 2 Types of Massage and Usual Care on Chronic Low Back Pain: A Randomized, Controlled Trial 
Annals of internal medicine  2011;155(1):1-9.
Background
Few studies have evaluated the effectiveness of massage for back pain.
Objective
To evaluate the effectiveness of two types of massage for chronic back pain.
Design
Single-blind parallel group randomized controlled trial.
Setting
Integrated health care delivery system in Seattle area.
Patients
401 persons 20 to 65 years of age with non-specific chronic low back pain.
Interventions
Ten treatments over 10 weeks of Structural Massage (intended to identify and alleviate musculoskeletal contributors to pain through focused soft-tissue manipulation) (n=132) or Relaxation Massage (intended to decrease pain and dysfunction by inducing relaxation) (n=136). Treatments provided by 27 experienced licensed massage therapists. Comparison group received continued usual care (n=133). Study presented as comparison of usual care with two types of massage.
Measurements
Primary outcomes were the Roland Disability Questionnaire (RDQ) and the Symptom Bothersomeness scale measured at 10 weeks. Outcomes also measured after 26 and 52 weeks.
Results
At 10 weeks, the massage groups had similar functional outcomes that were superior to those for usual care. The adjusted mean RDQ scores were 2.9 and 2.4 points lower for the relaxation and structural massage groups, respectively, compared to usual care (95% CIs: [1.8, 4.0] and [1.4, 3.5]). Adjusted mean symptom bothersomeness scores were 1.7 points and 1.4 points lower with relaxation and structural massage, respectively, versus usual care (95% CIs: [1.2, 2.2] and [0.8, 1.9]). The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks, but were small.
Limitations
Restricted to single site; therapists and patients not blinded to treatment.
Conclusions
This study confirms the results of smaller trials that massage is an effective treatment for chronic back pain with benefits lasting at least 6 months, and also finds no evidence of a clinically-meaningful difference in the effectiveness of two distinct types of massage.
Primary Funding Source
National Center for Complementary and Alternative Medicine
doi:10.1059/0003-4819-155-1-201107050-00002
PMCID: PMC3570565  PMID: 21727288

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