Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain

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.

Inclusion Criteria:

- clinical Diagnosis of Low Back Pain lasting at least 3 months

- pain of at least 4 on a 0-10 bothersomeness scale

Exclusion Criteria:

- do not currently have back pain

- current back pain episode less then 3 months in duration

- current back pain is only reported as mild in dysfunction and symptoms (i.e., less
than a score of 7 on the 0-23 modified Roland Scale or a bothersomeness score lower
than 4 on a 0-10 scale);

- sciatica

- underlying systemic or visceral disease

- pregnancy

- abdominal aneurisms

- spondylolisthesis

- discitis

- spinal stenosis

- spinal infections

- cancer or unexplained weight loss

- recent vertebral fracture

- current or past participation in classes or therapies closely resembling our MBSR or
CBT interventions for chronic pain

- have physical problems that won't allow them to do yoga (i.e., gross obesity, severe
pain when bending or twisting, unable to get up and down from the floor)

- involved with litigation or compensation claim for back pain

- evidence of severe or progressive neurologic deficits

- radiculopathy

- fibromyalgia diagnosis

- rheumatoid arthritis

- back surgery within the last 2 years

- unstable medical or severe psychiatric conditions

- unable to speak or read English

- unable to hear

- plan to move out of town