A Phase 3 interventional study of Cognitive Behavioral Therapy and Mindfulness Based Stress Reduction in Low Back Pain, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-13.
Sponsored by Kaiser Permanente · Phase 3, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 342 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
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Exclusion Criteria:
Participants randomized to the CBT intervention will attend eight weekly 2 hour sessions.
Behavioral: Cognitive Behavioral Therapy
Participants randomized to the MBSR arm will attend eight weekly 2 hour MBSR sessions.
Behavioral: Mindfulness Based Stress Reduction
Participants randomized to Usual Care will continue to receive care for their low back pain as prescribed by his/her Primary Care Physician.
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.
Back pain-related dysfunction
Back-related dysfunction will be measured with the modified Roland Disability Questionnaire ("Roland scale"), which asks whether 23 specific activities were limited due to back pain during the past week (yes or no). This measure has been found to be reliable, valid and sensitive to clinical changes and is appropriate for telephone administration and patients with moderate disability.
Time frame: 26 weeks
Bothersomeness of back pain
Symptom bothersomeness will be measured by asking participants to rate how "bothersome" their back pain has been during the previous week on a 0 to 10 scale (0 = "not at all bothersome" and 10 = "extremely bothersome"). This question worked well in our previous trials and is highly correlated with a 0-10 measure of pain intensity (r=0.8 to 0.9). It is also highly correlated with measures of function and other outcome measures.
Time frame: 26 weeks
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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