This study, which implements procedures used in a completed pilot study (n=60), compares two approaches to the management of acute low back pain: usual care (standard benefit) vs. the choice of: usual care, chiropractic, acupuncture or massage therapy (expanded benefit). 480 subjects will be recruited from a health maintenance organization, Harvard Pilgrim Health Care/Harvard Vanguard Medical Associates. Patients with uncomplicated, acute low back pain will be randomized to either usual care (n=160) or choice of expanded benefits (n=320). Patients' preferences for individual therapies and expectations of improvement will be measured at baseline and throughout the study. Subjects randomized to the expanded benefits arm who choose chiropractic, acupuncture or massage will receive up to 10 treatments over a five-week period. Additional treatments will be available after the fifth week but will require a copayment. Treatments will be provided by licensed providers who have met strict credentialing criteria. Chiropractic, acupuncture or massage treatments will begin within 48 hours. Chiropractic, acupuncture and massage therapy scope of practice guidelines for the treatment of acute low back pain have been developed as have detailed data tracking procedures to be used at each patient visit. Symptom relief, functional status, restricted activity days, use of health care, and patient and provider satisfaction will be assessed at 2, 5,12, 26 and 52 weeks after initiation of treatment. Primary outcomes will include: 1) change in symptoms; 2) change in functional status; 3) patient satisfaction; and 4) total utilization of services associated with care for low back pain. Medical records and the HMO's cost management information system will identify use of services. All procedures have been successfully incorporated in an ongoing pilot (feasibility) study. It is hypothesized that patients offered their choice of expanded benefits will experience a more rapid improvement in symptoms, a faster return to baseline functional status, a decrease in utilization of conventional medical services, and will be more satisfied with their care. The study is a direct examination of the effectiveness of an insurance eligibility intervention, not a test of the efficacy of specific, non-allopathic treatment regimens. The results of this study will provide valuable information to clinicians, patients and third party payers on the relative benefits and costs of an """"""""expanded benefits"""""""" treatment option which incorporates chiropractic, acupuncture and massage services for low back pain.
| Myers, Samuel S; Phillips, Russell S; Davis, Roger B et al. (2008) Patient expectations as predictors of outcome in patients with acute low back pain. J Gen Intern Med 23:148-53 |
| Eisenberg, David M; Post, Diana E; Davis, Roger B et al. (2007) Addition of choice of complementary therapies to usual care for acute low back pain: a randomized controlled trial. Spine (Phila Pa 1976) 32:151-8 |
| Eisenberg, David M; Cohen, Michael H; Hrbek, Andrea et al. (2002) Credentialing complementary and alternative medical providers. Ann Intern Med 137:965-73 |
