Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Although national expenditures on back pain treatments have increased substantially over the
      past decade, the health and functional status of persons suffering from back pain has
      deteriorated. This trial will evaluate the effectiveness, and cost-effectiveness, of a safe
      and relatively inexpensive "mind-body" therapy that has the potential to provide relief to
      some of the millions of Americans who continue to suffer from chronic back pain.
    

Detailed description: 
      Chronic back pain remains one of the most common and challenging public health problems in
      the U.S.. Although the amount of money spent on back pain treatments has increased
      substantially over the past decade in the U.S., the health and functional status of persons
      suffering from back pain has deteriorated. There is a clear need to identify safe, effective,
      and cost-effective treatment options for this often debilitating and expensive problem. Some
      of the more promising treatments for chronic back pain include "mind-body" therapies that
      address both psychological and somatic aspects of the pain experience. This randomized trial
      will compare the effectiveness and cost-effectiveness of Mindfulness-Based Stress Reduction
      (MBSR), a well-established but inadequately-studied CAM mind-body therapy, with usual care
      for persons with chronic low back pain and dysfunction. This trial will also compare MBSR
      with a conventional mind-body therapy, Cognitive-Behavioral Therapy (CBT), which has been
      found to be a modestly to moderately effective treatment for chronic back pain. Should MBSR
      and/or CBT prove effective in this trial, the mechanisms (mediators) of the effects of these
      two different mind-body therapies on pain and dysfunction will be explored. Because CBT aims
      to alter patients' cognitive and behavioral responses to pain, whereas MBSR focuses on direct
      present moment experience and not on changing the thoughts or feelings about such experience,
      these two therapies are hypothesized to operate by different mechanisms. A total of 342
      adults aged 20 through 70 years who have moderately to severely disabling chronic back pain
      will be recruited and randomized in equal proportions to MBSR, CBT, and treatment as usual
      (usual care). Both the MBSR and CBT interventions will be provided to groups of up to 15
      participants once a week for 8 weeks. The primary outcomes will be back pain-related
      functional limitations (Roland scale) and pain bothersomeness (rated on a 0-10 scale).
      Secondary outcomes include depression, anxiety, perceived stress, pain interference with
      activities, and sleep disturbance. Outcomes will be measured 4, 8, 26, and 52 weeks after
      randomization. If MBSR is at least moderately more effective than usual care, this safe and
      relatively inexpensive therapy would provide an appealing treatment option for chronic back
      pain that could be made more widely available. Because of the high prevalence and costs of
      chronic back pain, treatments with even modest impact on pain and function could produce a
      large benefit on a population level.
    

Intervention name(s): Cognitive Behavioral Therapy; Mindfulness Based Stress Reduction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Cognitive Behavioral Therapy Intervention will be delivered during 8 weekly classes each lasting 2 hours. The classes will be held at a conveniently located Group Health Facility.; The Mindfulness Based Stress Reduction Classes will be delivered in 8 weekly classes each lasting 2 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy; Mindfulness Based Stress Reduction