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

BACKGROUND: Few studies have evaluated the effectiveness of massage for chronic low back pain. OBJECTIVE: To compare the effectiveness of 2 types of massage and usual care for chronic back pain. DESIGN: Parallel-group randomized, controlled trial. Randomization was computer-generated, with centralized allocation concealment. Participants were blinded to massage type but not to assignment to massage versus usual care. Massage therapists were unblinded. The study personnel who assessed outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00371384) SETTING: An integrated health care delivery system in the Seattle area. PATIENTS: 401 persons 20 to 65 years of age with nonspecific chronic low back pain. INTERVENTION: Structural massage (n = 132), relaxation massage (n = 136), or usual care (n = 133). MEASUREMENTS: Roland Disability Questionnaire (RDQ) and symptom bothersomeness scores at 10 weeks (primary outcome) and at 26 and 52 weeks (secondary outcomes). Mean group differences of at least 2 points on the RDQ and at least 1.5 points on the symptom bothersomeness scale were considered clinically meaningful. RESULTS: The massage groups had similar functional outcomes at 10 weeks. The adjusted mean RDQ score was 2.9 points (95% CI, 1.8 to 4.0 points) lower in the relaxation group and 2.5 points (CI, 1.4 to 3.5 points) lower in the structural massage group than in the usual care group, and adjusted mean symptom bothersomeness scores were 1.7 points (CI, 1.2 to 2.2 points) lower with relaxation massage and 1.4 points (CI, 0.8 to 1.9 points) lower with structural massage. The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks but were small. LIMITATION: Participants were not blinded to treatment. CONCLUSION: Massage therapy may be effective for treatment of chronic back pain, with benefits lasting at least 6 months. No clinically meaningful difference between relaxation and structural massage was observed in terms of relieving disability or symptoms. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine.

Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial.

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.

A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.

BACKGROUND: Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. METHODS: A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks. RESULTS: At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P < .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P < .001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P > .05). CONCLUSIONS: Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial.

BACKGROUND: Chronic back pain is a major public health problem and the primary reason patients seek acupuncture treatment. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients with this common condition. This study addresses methodological shortcomings that have plagued previous studies evaluating acupuncture for chronic low back pain. METHODS AND DESIGN: A total of 640 participants (160 in each of four arms) between the ages of 18 and 70 years of age who have low back pain lasting at least 3 months will be recruited from integrated health care delivery systems in Seattle and Oakland. They will be randomized to one of two forms of Traditional Chinese Medical (TCM) acupuncture needling (individualized or standardized), a "control" group (simulated acupuncture), or to continued usual medical care. Ten treatments will be provided over 7 weeks. Study participants and the "Diagnostician" acupuncturists who evaluate participants and propose individualized treatments will be masked to the acupuncture treatment actually assigned each participant. The "Therapist" acupuncturists providing the treatments will not be masked but will have limited verbal interaction with participants. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, and use and costs of healthcare services for back pain will also be measured. The primary analysis comparing outcomes by randomized treatment assignment will be analysis of covariance adjusted for baseline value. For both primary outcome measures, this trial will have 99% power to detect the presence of a minimal clinically significant difference among all four treatment groups and over 80% power for most 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 acupuncture needling as a treatment for chronic low back pain. TRIAL REGISTRATION: Clinical Trials.gov NCT00065585.

Delivering effective primary care to older adults: a randomized, controlled trial of the senior resource team at group health cooperative.

OBJECTIVES: To assess the effect of a team of geriatrics specialists on the practice style of primary care providers (PCPs) and the functioning of their patients aged 75 and older. DESIGN: Randomized, controlled trial. SETTING: Two primary care clinics in the Seattle, Washington, area. PARTICIPANTS: Thirty-one PCPs and 874 patients aged 75 and older. INTERVENTION: An interdisciplinary team of geriatrics specialists worked with patients and providers to enhance the geriatric focus of care. MEASUREMENTS: Main outcomes were a practice style reflecting a geriatric orientation and patient scores on the physical and affect subscales of the Arthritis Impact Measurement Scale 2-Short Form. Secondary outcomes were hospitalizations, incident disability in activities of daily living (ADLs), and PCP perceptions of the intervention. Death rates were also assessed. RESULTS: Intervention providers screened significantly more for geriatric syndromes at 12 months, but this finding did not persist at 24 months. There were no significant differences in adequate hypertension control or high-risk prescribing at 12 or 24 months of follow-up. There were no significant differences in patient functioning or significant differences in hospitalization rates at either time point. Meaningful differences were observed in ADL disability at 12 but not 24 months. PCPs viewed the intervention favorably. Seventy-eight participants died over the 24 months of follow-up; the proportion dying was higher in the intervention group (11.4% in intervention group vs 7.1% of controls, P=.03). CONCLUSION: The addition of an interdisciplinary geriatric team was acceptable to PCPs and had some effect on care of geriatric conditions but little effect on patient function or the use of inpatient care and was associated with greater mortality.

A method for describing and evaluating naturopathic whole practice.

CONTEXT: Even though complementary and alternative medicine (CAM) is generally practiced as distinct systems of medicine, almost all CAM research has focused on single therapies. In order to more adequately evaluate the effectiveness of these medical systems, studies that evaluate the outcome of intact whole systems are needed. One challenge lies in defining the whole medical system (and any medical system it is compared to) in a way that ensures treatment fidelity. OBJECTIVE: This paper presents a proposed method to measure treatment fidelity (treatment criteria) in studies of the naturopathic medical system. DESIGN: Illustrative example of the theory-based development and post-hoc "testing" of treatment criteria against an existing database of actual treatments prescribed by a random sample of naturopathic physicians. MAIN OUTCOME MEASURES: Treatment criteria for 3 conditions--menopausal symptoms, bowel dysfunction, and fatigue/fibromyalgia--and their comparison to actual treatments prescribed. RESULTS: A set of meaningful, measurable treatment criteria based on the naturopathic practice principles were defined that could have generated the majority (82%-93%) of treatment prescriptions given at visits for these conditions. Several of the treatment criteria components are common across the 3 conditions studied, and might be appropriate for all visits to doctors of naturopathy (NDs). Others are specific to each condition. In addition to ensuring model validity, these criteria help identify critical components of care, enable study replication, provide a measure of quality of care, and are one step toward allowing CAM to be studied as it is generally practiced-as distinct systems of medicine. SETTING: Work was performed at Bastyr University and the University of Arizona.

The diagnosis and treatment of chronic back pain by acupuncturists, chiropractors, and massage therapists.

OBJECTIVES: To describe the diagnostic and therapeutic content of visits for chronic back pain to acupuncturists, chiropractors, and massage therapists. METHODS: Randomly selected acupuncturists, chiropractors, and massage therapists in two states were surveyed, and then eligible providers collected data on consecutive patient visits. The authors analyzed information on diagnosis, treatment, and self-care recommendations for chronic back pain patients collected during consecutive patient visits to these complementary and alternative medicine (CAM) providers. RESULTS: Back pain was the most common reason for visits to each of these providers, with chronic back pain representing about 10% of visits to acupuncturists, 20% of visits to chiropractors, and 12% of visits to massage therapists. Diagnosis by acupuncturists included traditional questioning and inspecting the patient as well as pulse and tongue assessment and palpation of the acupuncture meridians. Treatments usually included acupuncture needling, heat of some sort, and other modalities, such as East Asian massage, herbs, and/or cupping (application of suction cups to the skin). Lifestyle recommendations were common, particularly exercise and dietary counseling. Visits to chiropractors usually included spinal and muscle/soft tissue examinations and spinal manipulation. Soft tissue techniques (eg, "active release"), stretch or strength training, and home exercise recommendations were much less common. Massage therapists usually performed a tissue assessment and commonly assessed range of motion. They emphasized Swedish, deep tissue, and trigger point massage techniques and usually made self-care recommendations, particularly increased water intake, hot/cold therapy, exercise, and body awareness. CONCLUSION: Information on the care patients routinely receive from CAM providers will help physicians better understand these increasingly popular forms of care.

Comparing yoga, exercise, and a self-care book for chronic low back pain: a randomized, controlled trial.

BACKGROUND: Chronic low back pain is a common problem that has only modestly effective treatment options. OBJECTIVE: To determine whether yoga is more effective than conventional therapeutic exercise or a self-care book for patients with chronic low back pain. DESIGN: Randomized, controlled trial. SETTING: A nonprofit, integrated health care system. PATIENTS: 101 adults with chronic low back pain. INTERVENTION: 12-week sessions of yoga or conventional therapeutic exercise classes or a self-care book. MEASUREMENTS: Primary outcomes were back-related functional status (modified 24-point Roland Disability Scale) and "bothersomeness" of pain (11-point numerical scale). The primary time point was 12 weeks. Clinically significant change was considered to be 2.5 points on the functional status scale and 1.5 points on the bothersomeness scale. Secondary outcomes were days of restricted activity, general health status, and medication use. RESULTS: After adjustment for baseline values, back-related function in the yoga group was superior to the book and exercise groups at 12 weeks (yoga vs. book: mean difference, -3.4 [95% CI, -5.1 to - 1.6] [P < 0.001]; yoga vs. exercise: mean difference, -1.8 [CI, -3.5 to - 0.1] [P = 0.034]). No significant differences in symptom bothersomeness were found between any 2 groups at 12 weeks; at 26 weeks, the yoga group was superior to the book group with respect to this measure (mean difference, -2.2 [CI, -3.2 to - 1.2]; P < 0.001). At 26 weeks, back-related function in the yoga group was superior to the book group (mean difference, -3.6 [CI, -5.4 to - 1.8]; P < 0.001). LIMITATIONS: Participants in this study were followed for only 26 weeks after randomization. Only 1 instructor delivered each intervention. CONCLUSIONS: Yoga was more effective than a self-care book for improving function and reducing chronic low back pain, and the benefits persisted for at least several months.

A survey of training and practice patterns of massage therapists in two US states.

BACKGROUND: Despite the growing popularity of therapeutic massage in the US, little is known about the training or practice characteristics of massage therapists. The objective of this study was to describe these characteristics. METHODS: As part of a study of random samples of complementary and alternative medicine (CAM) practitioners, we interviewed 226 massage therapists licensed in Connecticut and Washington state by telephone in 1998 and 1999 (85% of those contacted) and then asked a sample of them to record information on 20 consecutive visits to their practices (total of 2005 consecutive visits). RESULTS: Most massage therapists were women (85%), white (95%), and had completed some continuing education training (79% in Connecticut and 52% in Washington). They treated a limited number of conditions, most commonly musculoskeletal (59% and 63%) (especially back, neck, and shoulder problems), wellness care (20% and 19%), and psychological complaints (9% and 6%) (especially anxiety and depression). Practitioners commonly used one or more assessment techniques (67% and 74%) and gave a massage emphasizing Swedish (81% and 77%), deep tissue (63% and 65%), and trigger/pressure point techniques (52% and 46%). Self-care recommendations, including increasing water intake, body awareness, and specific forms of movement, were made as part of more than 80% of visits. Although most patients self-referred to massage, more than one-quarter were receiving concomitant care for the same problem from a physician. Massage therapists rarely communicated with these physicians. CONCLUSION: This study provides new information about licensed massage therapists that should be useful to physicians and other healthcare providers interested in learning about massage therapy in order to advise their patients about this popular CAM therapy.

The practice of acupuncture: who are the providers and what do they do?

PURPOSE: This study provides basic information about the training and practices of licensed acupuncturists. METHODS: Randomly selected licensed acupuncturists in Massachusetts and Washington state were interviewed and asked to record information on 20 consecutive patient visits. RESULTS: Most acupuncturists in both states had 3 or 4 years of academic acupuncture training and had received additional "postgraduate" training as well. Acupuncturists treated a wide range of conditions, including musculoskeletal problems (usually back, neck, and shoulder) (33% in Massachusetts and 47% in Washington), general body symptoms (12% and 9%, respectively) such as fatigue, neurological problems (10% and 12%, respectively) (eg, headaches), and psychological complaints (10% and 8%, respectively) (especially anxiety and depression). Traditional Chinese medicine (TCM) was the predominant style of acupuncture used in both states (79% and 86%, respectively). Most visits included a traditional diagnostic assessment (more than 99%), regular body acupuncture (95% and 93%, respectively), and additional treatment modalities (79% and 77%, respectively). These included heat and lifestyle advice (66% and 65%, respectively), most commonly dietary advice and exercise recommendations. Chinese herbs were used in about one third of visits. Although most patients self-referred to acupuncture, about one half received concomitant care from a physician. Acupuncturists rarely communicated with the physicians of their patients who were providing care for the same problem. CONCLUSIONS: This study contributes new information about acupuncturists and the care they provide that should be useful to clinicians interested in becoming more knowledgeable about complementary or alternative medical therapies available to their patients.

Practice patterns of naturopathic physicians: results from a random survey of licensed practitioners in two US States.

BACKGROUND: Despite the growing use of complementary and alternative medicine (CAM) by consumers in the U.S., little is known about the practice of CAM providers. The objective of this study was to describe and compare the practice patterns of naturopathic physicians in Washington State and Connecticut. METHODS: Telephone interviews were conducted with state-wide random samples of licensed naturopathic physicians and data were collected on consecutive patient visits in 1998 and 1999. The main outcome measures were: Sociodemographic, training and practice characteristics of naturopathic physicians; and demographics, reasons for visit, types of treatments, payment source and visit duration for patients. RESULT: One hundred and seventy practitioners were interviewed and 99 recorded data on a total of 1817 patient visits. Naturopathic physicians in Washington and Connecticut had similar demographic and practice characteristics. Both the practitioners and their patients were primarily White and female. Almost 75% of all naturopathic visits were for chronic complaints, most frequently fatigue, headache, and back symptoms. Complete blood counts, serum chemistries, lipids panels and stool analyses were ordered for 4% to 10% of visits. All other diagnostic tests were ordered less frequently. The most commonly prescribed naturopathic therapeutics were: botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). The mean visit length was about 40 minutes. Approximately half the visits were paid directly by the patient. CONCLUSION: This study provides information that will help other health care providers, patients and policy makers better understand the nature of naturopathic care.

Complementary and alternative medical therapies for chronic low back pain: What treatments are patients willing to try?

BACKGROUND: Although back pain is the most common reason patients use complementary and alternative medical (CAM) therapies, little is known about the willingness of primary care back pain patients to try these therapies. As part of an effort to refine recruitment strategies for clinical trials, we sought to determine if back pain patients are willing to try acupuncture, chiropractic, massage, meditation, and t'ai chi and to learn about their knowledge of, experience with, and perceptions about each of these therapies. METHODS: We identified English-speaking patients with diagnoses consistent with chronic low back pain using automated visit data from one health care organization in Boston and another in Seattle. We were able to confirm the eligibility status (i.e., current low back pain that had lasted at least 3 months) of 70% of the patients with such diagnoses and all eligible respondents were interviewed. RESULTS: Except for chiropractic, knowledge about these therapies was low. Chiropractic and massage had been used by the largest fractions of respondents (54% and 38%, respectively), mostly for back pain (45% and 24%, respectively). Among prior users of specific CAM therapies for back pain, massage was rated most helpful. Users of chiropractic reported treatment-related "significant discomfort, pain or harm" more often (23%) than users of other therapies (5-16%). Respondents expected massage would be most helpful (median of 7 on a 0 to 10 scale) and meditation least helpful (median of 3) in relieving their current pain. Most respondents indicated they would be "very likely" to try acupuncture, massage, or chiropractic for their back pain if they did not have to pay out of pocket and their physician thought it was a reasonable treatment option. CONCLUSIONS: Most patients with chronic back pain in our sample were interested in trying therapeutic options that lie outside the conventional medical spectrum. This highlights the need for additional studies evaluating their effectiveness and suggests that researchers conducting clinical trials of these therapies may not have difficulties recruiting patients.