A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial.

Context Massage therapy is widely used for back pain. Contribution Patients with chronic low back pain who received 10 weekly sessions of structural or relaxation massage therapy experienced clinically important improvements in symptoms and disability compared with patients who received usual care. There was no apparent difference in effect between the 2 types of massage. Caution Participants assigned to usual care knew that they were not receiving massage therapy and may have been more likely to report less improvement. Implication Massage therapy seemed to be an effective short- and longer-term treatment for chronic low back pain. There was no apparent difference between relaxation and structural massage, the latter of which may be more expensive and requires specialized techniques. The Editors Massage is one of the most popular complementary and alternative medical therapies for neck and back pain (1), conditions that account for more than one third (2) of the more than 100 million annual visits to massage therapists in the United States (3). Almost all massage therapists in the United States use Swedish massage techniques aimed at relaxation, but only a minority take courses in such techniques as structural massage for treatment of chronic low back pain. Recent reviews have found limited evidence that massage is an effective treatment of chronic back pain (4, 5), and no studies have compared relaxation massage with structural massage, which focuses on correcting soft-tissue abnormalities. We therefore conducted a trial to determine whether relaxation massage reduces pain and improves function in patients with chronic low back pain and compared relaxation and structural massage for treating this condition. Methods Study Design Study procedures are described in detail elsewhere (6). In brief, we used advertisements in the health plan magazine of the Group Health Cooperative and mailings to invite members of the plan who were aged 20 to 65 years and had outpatient visit diagnoses suggesting nonspecific chronic low back pain to participate in the trial. Invitation letters were mailed 3 to 12 months after visits. Study staff phoned respondents to determine their eligibility; criteria were low back pain lasting at least 3 months without 2 or more pain-free weeks and pain bothersomeness rated at least 3 on a scale of 0 to 10. Exclusion criteria were 1) specific causes of back pain (for example, cancer, fractures, or spinal stenosis), 2) complicated back problems (for example, sciatica, back surgery in the past 3 years, or medicolegal issues), 3) conditions making treatment difficult (for example, paralysis or psychoses), 4) conditions that might confound treatment effects or interpretation of results (for example, severe fibromyalgia or rheumatoid arthritis), 5) inability to speak English, 6) massage within the past year, or 7) plans to visit a provider for back pain. Eligible respondents were administered a baseline questionnaire and randomly assigned to a treatment group. All participants gave written informed consent, and the study was approved by the institutional review board of Group Health Cooperative. Randomization and Interventions The randomization schedule was created by a biostatistician and was blocked on massage therapist; allocation was centrally generated and concealed. Participants were randomly allocated in a 1:1:1 ratio to receive usual care, relaxation massage, and structural massage. Therapists were not blinded to the type of massage that they provided. Participants knew whether they received massage but were blinded to type; usual care recipients were aware that they had enrolled in a trial of massage. Study personnel assessing trial outcomes were blinded to study assignment. Study Treatments Massage was provided by 27 licensed therapists with at least 5 years of experience who were comfortable following the study protocol and had experience in the permitted techniques. Therapists received 1.5 days of protocol training (6). Treatment fidelity was promoted by monitoring treatment forms that the therapists completed at each visit, along with corrective feedback and a midstudy meeting. Both massage techniques were provided in the therapists' offices at no cost. Both massage protocols prescribed 10 weekly treatments, with first visits lasting 75 to 90 minutes and follow-up visits lasting 50 to 60 minutes. We defined adherence as completion of at least 8 visits. At each visit, therapists could recommend up to 3 home exercises from a predefined list of 7 exercises, 6 of which were common to both treatments (6). Relaxation massage, which is intended to induce a generalized sense of relaxation, comprised effleurage, petrissage, circular friction, vibration, rocking and jostling, and holding. Therapists were given time limits for each body region, including 7 to 20 minutes on the back and buttocks (6). Therapists could provide a compact disk of a 2.5-minute relaxation exercise to be done at home to enhance and prolong treatment benefits. Structural massage, which is intended to identify and alleviate musculoskeletal contributors to back pain, comprised myofascial, neuromuscular, and other soft-tissue techniques (6). Myofascial techniques are intended to engage and release identified restrictions in myofascial tissues. Neuromuscular techniques are used to resolve soft-tissue abnormalities by mobilizing restricted joints, lengthening constricted muscles and fascia, balancing agonist and antagonist muscles, and reducing hypertonicity. The areas of the body that were treated varied across patients and treatment sessions. Therapists could recommend a home exercise consisting of psoas stretch to enhance and prolong any benefits of structural massage. Usual care participants received no special care but were paid $50. Actual care was determined from medical records and interviews. Outcomes and Follow-up Outcomes were measured at baseline and at 10, 26, and 52 weeks by interviewers who were masked to treatment assignment. Prespecified primary outcomes were back painrelated dysfunction and symptoms at 10 weeks, immediately after treatment completion. Dysfunction was measured by using the modified Roland Disability Questionnaire (RDQ), a reliable, valid, and sensitive measure with substantial construct validity (7, 8). A between-group difference in improvement in mean values of at least 2 points on this scale of 0 to 23 points was considered clinically meaningful (8, 9). Symptoms were assessed by asking participants to rate the bothersomeness of their pain during the past week from 0 (not at all) to 10 (extremely). A between-group difference in improvement in mean values of at least 1.5 points was considered clinically meaningful (8, 9). Secondary outcomes were 1) 26- and 52-week measures of the primary outcomes; 2) percentage of participants with prespecified clinically meaningful, individual-level reductions in dysfunction (3-point decrease in RDQ score) and symptoms (2-point decrease in symptom bothersomeness score); 3) physical and mental health Short Form-12 Health Survey component summary scores (10); 4) self-reported medication use for back pain in the previous week; 5) days spent in bed, home from work or school, or cutting down on usual activities because of back problems during the past week (11); 6) global improvement in back painrelated dysfunction, rated on a 7-point scale from completely gone to much worse; 7) the patient's feelings about spending the rest of his or her life with the back pain experienced in the past week (7-point scale ranging from delighted to terrible); 8) satisfaction with back care, rated by using a 5-point Likert scale (ranging from very satisfied to very dissatisfied); and 9) total costs of back painrelated visits, imaging studies, and medications during the follow-up year, as ascertained from electronic medical records. Visits not covered by the health plan were identified from interviews. Finally, participants were asked open-ended questions about adverse experiences on the 10-week interview and at each massage visit. Statistical Analysis Sample size was calculated to ensure adequate power at 10 weeks to detect a clinically meaningful 2-point mean difference between the structural massage and usual care groups in RDQ scores, assuming that the structural massage group would have scores that were 1 point better than the relaxation massage group. Assuming 10% loss to follow-up and SDs that were derived from our pilot study of 92 participants (SD, 4.65 for RDQ score and 2.71 for symptom bothersomeness score), we estimated that a target sample of 399 persons (133 per group) was needed. For RDQ scores, this provided 85% power to detect a significant difference among the 3 treatment groups by using an omnibus Wald test and 91% power to detect a pairwise difference of 2 points; for symptom bothersomeness scores, it provided greater than 99% power to detect a significant difference among the 3 treatment groups and 99% power to detect a pairwise difference of 1.5 points. Analyses were conducted according to the original randomized treatment assignment regardless of adherence to protocol. Analyses were conducted by using regression through generalized estimating equations (12) with an independent working correlation structure and robust SE estimates taking into account multiple outcomes per participant. Follow-up times were treated as categorical variables using dummy variables for each treatment, each time point, and all 2-way interactions between follow-up time and treatment. Adjusted models included baseline covariates that were prespecified, were imbalanced at baseline (that is, potential confounders), or were associated with a primary outcome (that is, precision variables): age, group, sex, baseline RDQ and symptom bothersomeness scores, education level, body mass index, type of work, original cause of back pain, more than 7 days of reduced activities because of back pain, an