Evidence-Based Evaluation of Complementary Health Approaches for Pain Management in the United States

We found 4 RCTs (total participants, 1092)^{,  ,  ,}  that assessed the clinical benefit of acupuncture for treatment of low back pain (LBP) (age range, 28-60 years; most participants were white) and used primary study outcomes of self-report of pain intensity (numeric rating scale or visual analog scale [VAS]) and/or functional disability (Roland-Morris Disability Questionnaire, Oswestry Disability Index [ODI], or Disability Rating Index). Cherkin et al^,  reported modest improvement in pain intensity and function compared with usual care. In pregnant women using auricular acupuncture, Wang et al found a significant reduction in pain intensity and improved functional status compared with no treatment. Comparison of verum to sham acupuncture had mixed results, with 2 RCTS^,  finding no significant difference and 1 RCT finding a slight but significant difference. No significant adverse events were reported.

We identified 8 RCTs that studied the use of massage for LBP^{,  ,  ,  ,  ,  ,  ,}  (total participants, 829). Massage types included Swedish/relaxation, structural, structural integration, and muscle energy; sessions varied in duration from 15 to 90 minutes. For chronic LBP (cLBP), 2 larger studies^,  comparing massage with usual care reported modest improvements in pain and function at 10 weeks, but the benefit was not sustained at 52 weeks. Three smaller studies compared massage to either usual outpatient rehabilitation or relaxation^,  and did not observe significant between-group differences for pain and/or function. For acute or subacute LBP, 2 smaller studies found significant, albeit modest, improvements in pain compared with no treatment (−1.5 points on a numeric rating scale) or function (−18% on the ODI) compared with a putative placebo. No RCTs reported significant adverse events.

Six RCTs of osteopathic manipulative therapy (OMT) for LBP were identified (total participants, 1308).^{,  ,  ,  ,  ,}  Two RCTs examined OMT compared with sham OMT for cLBP^,  using similar intervention paradigms and reported mixed results, with 1 finding no significant difference and 1 reporting a 9-mm reduction in pain intensity on a VAS. Two RCTs compared OMT with usual care for acute or subacute LBP,^,  and both reported no significant improvement for function/disability but mixed results for pain intensity for between-group differences. In pregnant women with LBP, 2 studies compared the benefit of adding OMT or placebo ultrasound treatment to usual obstetric care and reported significant modest improvements with added care but no significant between-group differences.^,  No RCTs reported significant adverse events.

We reviewed 24 RCTs^{,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  ,}  (total participants, 4503; all adults) of spinal manipulation (SM) for LBP. Recent data suggest that for cLBP, the “dose” of SM (defined as the number of sessions) may affect outcomes,^{,  ,}  and hence the dose utilized was dichotomized for this report depending on whether 6 or more sessions of SM were provided in a given study. No RCTs reported significant adverse events.

We identified 6 RCTs of yoga for cLBP^{,  ,  ,  ,  ,}  (total participants, 596; all adults, predominantly female). Three named forms of yoga were studied: hatha,^,  viniyoga,^,  and iyengar^,  ; all were performed in group settings, with class durations from 60 to 90 minutes and the number of sessions ranging from 12 to 24, either once or twice per week, with recommendations for home practice. Compared with usual care, 2 studies^,  found that yoga provided improvements in pain and function, but the results were mixed when compared with exercise/stretching. A dose-response study compared once-weekly to twice-weekly classes and found that they produced equivalent improvements in pain intensity and function. Three smaller studies compared yoga with wait list^,  or education control and reported significant modest reductions in pain intensity and function/disability. No RCTs reported significant adverse events.

Additional information on all back pain RCTs can be found in Supplemental Table 1 (available online at http://www.mayoclinicproceedings.org).

Four RCTs examined acupuncture vs sham acupuncture for pain, physical function, global well-being, sleep, fatigue, and adverse events.^{,  ,  ,}  Martin et al found a significant improvement between electroacupuncture vs sham electroacupuncture. Differences were seen on the Fibromyalgia Impact Questionnaire (FIQ) scores for fatigue and anxiety. No other trial found significant differences between groups on any outcome. There were no serious adverse events reported in any of these studies. In one study, minor adverse events (eg, discomfort at the site of needle insertion or simulation of needles) were reported by 89% of participants.

Two studies (93 total participants, mostly female and white) investigated biofeedback vs control groups (attention control and placebo) as a treatment for symptoms of fibromyalgia.^,  Buckelew et al found a significant improvement in the Tender Point Index score in the biofeedback group vs an attention control group but not for any other outcome measure. Nelson et al did not find any differences between biofeedback and a placebo biofeedback. A small study (90 women) found that mindfulness-based stress reduction significantly reduced perceived stress and sleep disturbance and lessened the severity of symptoms in persons with fibromyalgia vs a wait list control group. Another RCT examined the effects of affective self-awareness, a technique that places primary importance on the awareness and expression of emotions underlying fibromyalgia symptoms, in 45 women with fibromyalgia and found significant pain reduction and improved physical functioning vs a wait list control group. Astin et al examined the effects of an intervention combining mindfulness meditation and qigong and found that the combined intervention yielded no better results than an educational/support control group for pain, depression, and physical functioning. Two studies^,  (112 total participants, mostly female) examined guided imagery vs usual care as a treatment for symptoms of fibromyalgia. One study found a significant decrease in the FIQ score compared with the usual care control group. The second study found positive effects of guided imagery on pain intensity, fatigue, and depression vs the control group. Both studies found improvements in self-efficacy for managing symptoms. Only one study reported on adverse events, and none were noted.

A small study (12 women) examined Swedish massage vs myofascial release therapy for fibromyalgia symptoms. No difference was seen between groups on the FIQ.

A study of 98 adults with fibromyalgia (aged 40 years and older, mostly white and female) compared Yang-style tai chi (modified for fibromyalgia patients) with an educational control and found that the tai chi group had a greater decrease in the FIQ score. Another study (59 adults with fibromyalgia) compared Yang-style tai chi with a control combining wellness education and stretching classes and found that the tai chi group had greater improvement in the FIQ score.

A small study (53 women) investigated yoga vs wait list for management of fibromyalgia symptoms and found that those practicing yoga had significant improvement in the FIQ score. No adverse events were noted.

Additional information on all fibromyalgia RCTs can be found in Supplemental Table 2 (available online at http://www.mayoclinicproceedings.org).

Four randomized controlled trials examined whether massage could relieve symptoms associated with chronic neck pain.^{,  ,  ,}  One study did not report patient demographic characteristics, and the others studied patients aged 20 to 64 years. Primary outcomes included scores on the Neck Disability Index (NDI) (a 10-item neck pain questionnaire), the pain VAS, and range of motion. Sherman et al found significant improvement of the NDI score for those randomized to 10 massage therapy session over 10 weeks vs those assigned to a self-care book on managing neck problems. In an RCT by Field et al, individuals were randomized to either a wait list control or 30 minutes of massage therapy weekly for 4 weeks combined with daily self-massage. At the completion of the intervention, those assigned to massage therapy had improvements in pain and range of motion compared with the control group. Sherman et al reported a dose-response relationship between the number and duration of massage sessions per week and improvement in the NDI score and neck pain intensity. The findings indicated that 60 minutes of massage 2 to 3 times per week was significantly better than either 30 or 60 minutes of massage once per week after the 4 weeks of treatment. In a follow-up to the study by Sherman et al, Cook et al obtained repeated consent from the participants and randomized them to one additional massage therapy session per week for 6 additional weeks. At the end of treatment, those randomized to the additional sessions had significantly improved pain and function vs those who did not receive the additional sessions; the difference between groups was no longer significant after 14 weeks of follow-up.

We reviewed 3 randomized trials of SM for neck pain.^{,  ,}  One study assessed manipulation compared with mobilization with a 2×2×2 factorial design: with or without heat or with or without electrical muscle stimulation; no significant differences in outcomes were seen between groups. Evans et al compared SM combined with supervised exercising to supervised exercising alone and also to home exercise. After completion of the 12-week intervention, no difference was seen between SM combined with supervised exercising and supervised exercising alone; however, both these groups had significant improvement in neck pain vs only home exercise. Maiers et al assessed the efficacy of 3 treatments: (1) SM plus home exercise, (2) supervised rehabilitation exercise plus home exercise, and (3) home exercise alone. Spinal manipulation with home exercise produced significantly better reduction in pain than home exercise alone. No significant difference was seen between SM and home exercise vs supervised rehabilitation exercise plus home exercise.

There was one RCT of manual cervical distraction, a traction-based therapy with low, medium, and high forces assessed. The goal of the study was to identify a viable sham control. The study end points included pain VAS, NDI score, and a credibility and expectancy questionnaire. The investigators did report benefit in medium- or high-force interventions.

Additional information on all neck pain RCTs can be found in Supplemental Table 3 (available online at http://www.mayoclinicproceedings.org).

Four RCTs examined whether acupuncture could relieve symptoms associated with OA of the knee.^{,  ,  ,}  These studies used similar definitions of knee OA. Participants were predominantly female, had mean ages between 60 and 65 years, and had knee pain for an average of 9 to 11 years. All studies incorporated either the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score or the WOMAC pain subscore as the primary outcomes. In 2 of the trials,^,  no difference was seen between verum acupuncture and sham acupuncture for either the primary or secondary outcome measure. The third trial, which used a sham control, found significantly better improvement in both the WOMAC pain subscale and function subscale after 14 weeks of treatment. For the 3 trials that also incorporated either an attention control or standard care controls,^,  verum acupuncture produced significantly better improvement in primary and secondary outcomes than that observed in the control group. Across trials, adverse events associated with acupuncture were few, with the most common complaints being pain at the needling site and muscle soreness that resolved soon after the treatment session ended.

We reviewed 8 RCTs examining the efficacy of 2 dietary supplements, glucosamine and/or chondroitin, in individuals with knee OA.^{,  ,  ,  ,  ,  ,  ,}  These studies varied substantially in how knee OA was defined, as well as in the primary outcome measures used.

Three different configurations of glucosamine were used: glucosamine hydrochloride (HCl),^{,  ,}  glucosamine sulfate,^{,  ,}  and glucosamine bound to a polymer. One trial did not identify the configuration of glucosamine. Doses of glucosamine varied from 1000 mg/d for 6 weeks to 1500 mg/d for 24 weeks.^,  Chondroitin sulfate was studied in 2 trials at a dose of 1200 mg/d for 6 months^,  and in 1 trial at the same dose but for 8 weeks. All studies employed a placebo control group. Participants in 2 trials were exclusively or predominantly males, participants in 4 other trials were predominantly females,^{,  ,  ,}  and the remaining 2 trials had a close balance of men and women.^,  The mean age of the trial participants varied from 45 years to 72 years. Mixed results were found in trials comparing glucosamine vs a placebo control with pain relief or functional improvement as the primary outcomes. Three trials found glucosamine superior to placebo,^{,  ,}  and 3 trials found no difference between groups.^{,  ,}