Pilot Study to Test the Effectiveness of Combining Conventional and Complementary Medicine to Treat Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This pilot study will determine the feasibility of enrolling participants from different
      populations for a larger study of low back pain (LBP) treatment. In addition, this study will
      assess the effectiveness of data collection instruments and procedures as well as utilize
      feedback from participants to refine a future study.
    

Detailed description: 
      Back pain is one of the most common health problems in the United States, afflicting up to
      50% of adults each year. Back pain is the leading cause of visits to orthopedic surgeons and
      the second leading cause of visits to general practitioners. In the United States, the
      estimated annual cost of back pain, including medical costs and lost productivity, is between
      $50 and $100 billion. Unfortunately, conventional medical care has been largely ineffective
      in treating back pain of most people. An increasing number of people with back pain,
      particularly with LBP, are seeking relief from unconventional sources such as chiropractors
      and massage therapies. Although complementary and alternative medicine (CAM) therapies are
      being used to treat LBP, their effectiveness has not been thoroughly examined. Even less is
      known about the effectiveness of combining conventional medical care with CAM therapies to
      provide "integrative care." This pilot study will recruit participants from three different
      patient populations to determine the effectiveness of integrative care in treating LBP
      symptoms.

      This study will last 26 weeks and will comprise three participant populations: patients at an
      occupational health clinic, primary care patients at a medical clinic, and workers'
      compensation patients at the same medical clinic. At study start, participants will be
      interviewed about the care they have already received for LBP, any activities limited by
      their LBP, their attitudes toward CAM back pain treatments, job satisfaction, social support
      in the workplace, and medical history. Participants will also complete a self-report pain
      scale and a disability questionnaire. Participants will then be randomly assigned to either
      receive treatment for their LBP at an Integrative Care Center or continue to receive usual
      care provided by their medical or occupational health clinic.

      Participants assigned to receive integrative care will be evaluated by both a medical doctor
      and a CAM clinician immediately after being interviewed. Following the evaluation, the two
      clinicians will meet and develop a treatment plan, which will include conventional medical
      care and some form of CAM such as acupuncture, chiropractic, exercise, massage, mind-body
      therapy, or nutritional counseling. Treatments will occur either once or twice weekly for the
      12-week duration of treatment; clinicians may revise treatment plans during the study. LBP
      symptoms will be assessed through phone interviews at Weeks 2, 5, 12, and 26.
    

Intervention name(s): Integrative care for low back pain; Conventional treatment for low back pain
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Back Pain; Integrative Care; Acupuncture; Chiropractic; Exercise; Massage Therapy; Mind-Body Therapy; Nutritional Counseling; Complementary Therapies; Complementary and Alternative Medicine