Effectiveness of massage therapy for subacute low-back pain

Effectiveness of massage therapy for subacute low-back pain

26 novembre 2019

 

Faculty of Social Work, University of Toronto, and a member of the College of Massage Therapists of Ontario, Toronto, Ont.

 

 

 Background: The effectiveness of massage therapy for low-back pain has not been documented. This randomized controlled trial compared comprehensive mas- sage therapy (soft-tissue manipulation, remedial exercise and posture educa- tion), 2 components of massage therapy and placebo in the treatment of sub- acute (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 approxi- mately 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 Modi- fied 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.

Low-back pain affects a considerable proportion of the population.1,2 In a methodological review of prevalence studies of low-back pain,3 a mean point prevalence of 19.2% and a mean 1-year prevalence of 32.7% were esti- mated. Research on the effectiveness of treatment of subacute low-back pain has yielded inconsistent results,4-6 and studies often contain methodological flaws6-9 such as inadequate randomization procedures and lack of a placebo control. Flaws in studies employing massage include not using a registered massage therapist and making no attempt to ensure fidelity to a treatment model.8 Researchers have com- pared massage to other treatments of low-back pain but have used nonspecific mas- sage as a control.9 No studies were found that specifically evaluated massage ther- apy as a treatment for low-back pain.

This study compared the effectiveness of comprehensive massage therapy, 2 sepa- rate components of massage therapy (soft-tissue manipulation and remedial exercise with posture education) and a placebo of sham laser therapy for the treatment of subacute low-back pain. Outcome measures were function, pain, anxiety and lumbar range of motion.

Methods

This study was conducted at the Health and Performance Centre, University of Guelph, Guelph, Ont., which offers multi- disciplinary services such as sports medicine, physiotherapy and chiropractic manipulation. Treatments were provided and out- come measures were obtained at this centre. Ethics approval was obtained from the University of Guelph Ethics Review Commit- tee, and all subjects gave informed consent.

Subjects were recruited through university email, flyers sent to family physicians and advertisements in the local newspapers be- tween November 1998 and July 1999. Potential subjects aged 18 to 81 years were screened by telephone according to the following criteria: existence of subacute (between 1 week and 8 months) low-back pain; absence of significant pathology, such as bone frac- ture, nerve damage or severe psychiatric condition, including clin- ical depression as determined by a physician; no pregnancy; and stable health. The screening process relied on self-reported crite- ria plus information concerning the existence of medical condi- tions, medication use and the possibility of serious injury. Any doubt of appropriateness for inclusion was verified by the poten- tial subject’s physician. Having a history or previous episode of low-back pain and a positive radiograph finding of mild pathology were not reasons for exclusion.

Subjects were randomly assigned with the use of a random- numbers table to 1 of 4 groups: comprehensive massage therapy (soft-tissue manipulation, remedial exercise and posture educa- tion), soft-tissue manipulation only, remedial exercise with pos- ture education only or a placebo of sham laser treatment. Upon arrival for the first appointment, patient characteristics and health information, informed consent and baseline measures (function, pain, anxiety and lumbar range of motion) were recorded. All sub- jects received 6 treatments within about 1 month. Post-treatment measures were obtained after 1 month of treatment, and follow- up measures were obtained 1 month after treatment ended. Sub- jects were asked not to seek additional therapy for their backs for the 2 months that they were involved in the study. The 6 subjects (1 in the comprehensive massage therapy group, 2 in the soft- tissue manipulation group, 1 in the remedial exercise group and 2 in the sham laser group) who reported that they took aceta- minophen or anti-inflammatory medication for back pain were asked to refrain from doing so on test days until they had com- pleted all the outcome measures.

Treatment variables

For subjects in the comprehensive massage therapy group vari- ous soft-tissue manipulation techniques such as friction, trigger points and neuromuscular therapy were used to promote circula- tion and relaxation of spasm or tension. The exact soft tissue that the subject described as the source of pain was located and treated with the specific technique indicated for the specific condition of the soft tissue (e.g., friction for fibrous tissue and gentle trigger points for muscle spasm). The duration of the soft-tissue manipu- lation was between 30 and 35 minutes. For each treatment, stretching exercises for the trunk, hips and thighs, including flex- ion and modified extension, were taught and reviewed to ensure proper mechanics. Stretches were to be within a pain-free range, held for about 30 seconds in a relaxed manner, and performed twice on one occasion per day for the related areas and more fre- quently for the affected areas. Subjects were encouraged to engage

in general strengthening or mobility exercises such as walking, swimming or aerobics and to build overall fitness progressively. Compliance was recorded; 6 subjects (3 from the comprehensive massage therapy group and 3 from the remedial exercise group) had low compliance with performing the remedial exercise on their own. Education of posture and body mechanics, particularly as they related to work and daily activities, was provided. The exer- cise and education segment took about 15-20 minutes.

Subjects in the soft-tissue manipulation group received the same soft-tissue manipulation as the subjects in the comprehensive mas- sage therapy group and no other treatment. Those in the remedial exercise group received the same exercise and education compo- nents of treatment as subjects in the comprehensive massage ther- apy group. The control group received sham low-level laser (in- frared) therapy. The laser was set up to look as if it was functioning but was not. The subject was “treated” lying on his or her side with proper support to permit relaxation. The instrument was held on the area of complaint by the treatment provider, so the subject was attended for the duration of the session (about 20 minutes) to con- trol for the effects of interpersonal contact and support.

Two treatment providers were hired to deliver treatments, but it became necessary for the principle investigator, who is also a registered massage therapist, to provide treatment when the other providers experienced personal distress (e.g., death of a family member). The 2 providers hired for this study underwent training to enhance treatment delivery and similarity of delivery tech- niques; they also underwent process checks. Two of the treatment providers were massage therapists with more than 10 years’ experi- ence each; they provided treatment for the comprehensive massage therapy and soft-tissue manipulation groups. The third was a certi- fied personal trainer and certified weight-trainer supervisor who, with one of the massage therapists, provided treatment for the re- medial exercise and sham laser groups. The one objective measure, the range of motion test, was conducted by 3 physiotherapists who were blind to which group each subject was allocated.

Outcome measures

Two primary outcome measures were functionality and pain relief. The Roland Disability Questionnaire10 (RDQ), an adapta- tion of the Sickness Impact Profile, was used to measure subjects’ level of functioning when performing daily tasks. Scores can range from 0 to 24 based on responses to 24 questions to which subjects answer Yes or No. A score of 14 or more is considered a poor outcome.10 This questionnaire has shown reliability, validity and sensitivity10,11 and has been used in trials of the treatment of low- back pain.6,12,13

The McGill Pain Questionnaire14 consists of 2 indexes. The Present Pain Index (PPI) measures intensity of pain; the score ranges from 0 (no pain) to 5 (excruciating pain). The Pain Rating Index (PRI) measures quality of pain and is the sum total of 79 qualitative words the subject chooses to describe the pain. These indexes have shown reliability and validity.15-17

Two secondary outcome measures were anxiety and lumbar range of motion. The State Anxiety Index18,19 (SAI) comprises separate self-report scales to measure state (at this moment) anxi- ety. Scores can range from 20 (minimal anxiety) to 80 (maxi- mum). The norms of state anxiety for working adults are consid- ered to be 35.7 (standard deviation [SD] 10.4) for men and 35.2 (SD 10.6) for women. This index has shown reliability, validity and internal consistency18,19 and has been widely used in research20

in a variety of disciplines including psychology and medicine.21,22 Lumbar range of motion was measured with the Modified Schober test,23 and the norm is about 7 cm (SD 1.2).24 It has shown intraobserver (r = 0.99) and interobserver (r = 0.97) reli- ability25 and has been used in studies of the effectiveness of treat-

ment for subacute low-back pain.4,12
With a level of significance of 0.05 and a power of 0.80, mini-

mum samples of 20 subjects per group26 were required to detect a proportional reduction of pain of 50%. Outcome data were analysed by intention to treat and group means compared with ANOVA, and subsequently Scheffé (post hoc). Minimal, insignifi- cant differences between groups at baseline with near normal dis- tributions permitted analysis without adjustment.

Results

Of the 165 potential subjects who responded to the ad- vertisements, 107 (65%) met the inclusion criteria. Poten- tial subjects were most commonly excluded because their low-back pain was beyond the 8-month subacute cut-off (15 subjects), they were not currently experiencing low- back pain (13), or they indicated a diagnosis of complex health problems such as multiple sclerosis (9).

Of the 107 subjects who met the inclusion criteria (Table 1), 5 dropped out before treatment (3 before ran- domization, 1 from the comprehensive massage therapy group and 1 from the remedial exercise group), and 4 sub- jects dropped out before the end of the treatment (2 from the soft-tissue manipulation group, 1 from the remedial ex- ercise group and 1 from the sham laser group). These 4 subjects appeared typical at baseline. Because each group experienced a similar number of dropouts and results are based on comparisons of group means, these 4 subjects were excluded from analysis. One subject dropped out be- cause she experienced a motor vehicle accident after screening, 5 dropped out because they were “too busy” and 3 subjects could not give a clear reason.

Ninety-eight subjects (92%) completed the treatment: 25 received comprehensive massage therapy, 25 soft-tissue ma- nipulation, 22 remedial exercise and 26 sham laser treatment.

Follow-up measures were completed by 91 subjects (85%). The 4 treatment groups exhibited similar demographic characteristics (Table 2). The mean age of all subjects was 46 years, most (68%) were married or in a relationship with a partner, and most (70%) had at least a college education. The mean body mass index (kg/m2) was 25.5, which is considered overweight.

Previous episodes of low-back pain were experienced by 60% of the subjects, and the average duration of the present episode of pain was greater than 3 months. The most common reasons for low-back pain were identified by the subjects as bending or lifting injuries, work-related mild strains, sports injuries and unknown. There were no significant differences between the groups at baseline.

The post-treatment and follow-up outcome measures appear in Table 3. Statistically significant differences were found between the groups on self-reported measures of function, pain and state anxiety. There was no difference between the groups in lumbar range of motion.

Post hoc testing (Scheffé, significance at p < 0.05) for post-treatment scores indicated that the comprehensive massage therapy group had significantly better scores than the remedial exercise and sham laser groups on measures of function (RDQ), intensity of pain (PPI) and quality of pain (PRI) and significantly better scores than the soft-tissue manipulation group on the PPI. At follow-up the compre- hensive massage therapy group continued to have signifi- cantly improved scores over the sham laser group on the RDQ, PPI and PRI and had significantly better scores than the remedial exercise group on the RDQ and PPI.

At the end of treatment the soft-tissue manipulation group had significantly better scores than the remedial ex- ercise and sham laser groups on the RDQ and significantly better scores than the sham laser group on the PPI. At follow-up the soft-tissue manipulation group was not dis- tinguishable from the exercise group; both group means were statistically better than the mean for the sham laser group on the RDQ.

At the end of treatment the soft-tissue manipulation group had significantly better scores than the remedial ex- ercise and sham laser groups on the RDQ and significantly better scores than the sham laser group on the PPI. At follow-up the soft-tissue manipulation group was not dis- tinguishable from the exercise group; both group means were statistically better than the mean for the sham laser group on the RDQ.Schermata 2019-11-26 alle 14.47.50

At the end of treatment and at follow-up the comprehensive massage therapy group had significantly better scores than the sham laser group on state anxiety, whereas no other group did. The mean scores on the pain indexes for all of the groups was lower at the end of treatment than at baseline. All subjects’ reported levels of pain in the comprehensive massage therapy group decreased in intensity from baseline to post treatment, which did not occur in any other group. At the 1-month follow-up, 63% of the subjects in the comprehensive massage therapy group reported no pain, as compared with 27% in the soft-tissue manipulation group, 14% in the exercise group and 0% in the sham laser group.

Interpretation

A difference in RDQ scores of 2.5 has been considered to be minimally important in terms of clinical effects.28 When this criterion was applied to the outcome measures at follow-up in the present study, clinical significance was demonstrated in the comprehensive massage therapy group in comparison with the remedial exercise group (difference 4.2) and the sham laser group (difference 5.0). Clinical sig- nificance was also evident in the soft-tissue manipulation group at follow-up in comparison with the exercise group (difference 2.8) and the sham laser group (difference 3.6). Both the comprehensive massage therapy group and the soft-tissue manipulation group showed clinical significance for the improvement of function.

Schermata 2019-11-26 alle 14.48.12Self-reported levels of function and pain (intensity and quality) improved the most for patients with subacute low- back pain who had comprehensive massage therapy admin- istered by experienced massage therapists. Soft-tissue ma- nipulation was shown to have some benefit after treatment, but by follow-up there was no statistical difference between the soft-tissue manipulation group and the remedial exercise group. Comprehensive massage therapy was shown in this study to maintain statistical significance over the sham laser group on all 3 outcome measures and over the exercise group on 2 outcome measures. This did not occur for any other group. However, at follow-up there were no statistical differences between the comprehensive massage therapy group and the soft-tissue manipulation group. Soft-tissue manipulations were shown to have considerable benefit, and the addition of remedial exercise and posture education was shown to improve the clinical results moderately. Compre- hensive massage therapy seemed to have the greatest impact on pain scores but was only marginally better than soft- tissue manipulation alone for improving function.

The cost of treatment per subject in the comprehensive massage therapy group was $300 (6 sessions at $50 per treatment) and $240 for the soft-tissue manipulation group. The estimated cost of treatment per subject in the remedial exercise and sham laser groups was $90.

Thus, comprehensive massage therapy had the most benefit but cost $60 more per subject than soft-tissue manipulation alone.

Limitations of the study included the use of a single set- ting, the use of a specific form of massage therapy provided by only 2 massage therapists, unmeasured provider effects on the validity of outcome measures and the confines of the protocol (e.g., a set number of treatments regardless of the severity or complexity of the problem and short-term follow-up). The treatment was provided by therapists with clinical experience and continuing education that focused on physiology. It is likely that massage therapists with simi- lar education and training based on physiology, as opposed to reflexology or craniosacral therapy, would provide simi- lar treatment. Only in British Columbia and Ontario is massage therapy regulated, although most other provinces, except Quebec, have similar training.

This is the first randomized controlled trial of the effec- tiveness of massage therapy for subacute low-back pain. Replication of this study, comparisons with other forms of treatment and external evaluation are required to help as- certain which types of low-back problems with which types of complicating factors (e.g., levels of stress and activity) will respond best to massage therapy. Massage therapy that is based on physiology and emphasizes the soft-tissue ma- nipulation component of treatment was found to be effec- tive in the nonpharmacological management of subacute low-back pain.

Schermata 2019-11-26 alle 14.48.23

A special thanks is extended to Kevin Gorey, research adviser at the University of Windsor, Windsor, Ont. Gratefully acknowledged are Cyndy McLean, Centre Coordinator, and Terry Graham, Professor, University of Guelph, Guelph, Ont., for their support of the project. This project was funded by the College of Massage Therapists of Ontario (CMTO).

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