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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Group Health Cooperative
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01467843
First received: November 7, 2011
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Behavioral: Cognitive Behavioral Therapy
Behavioral: Mindfulness Based Stress Reduction
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Back pain-related dysfunction [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.

  • Bothersomeness of back pain [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 297
Study Start Date: June 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Behavioral Therapy
Participants randomized to the CBT intervention will attend eight weekly 2 - 2.5-hour sessions.
Behavioral: Cognitive Behavioral Therapy
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.
Active Comparator: Mindfulness-Based Stress Reduction
Participants randomized to the MBSR arm will attend eight weekly 2 hour MBSR sessions.
Behavioral: Mindfulness Based Stress Reduction
The Mindfulness Based Stress Reduction Classes will be delivered in 8 weekly classes each lasting 2 to 2.5 hours.
No Intervention: Usual Care
Participants randomized to Usual Care will continue to receive care for their low back pain as prescribed by his/her Primary Care Physician.

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 297 adults aged 20 through 64 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 11 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 5, 10, 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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467843

Contacts
Contact: Rene J Hawkes, BS 206-287-2073 hawkes.r@ghc.org

Locations
United States, Washington
Group Health Cooperative Recruiting
Seattle, Washington, United States, 98101
Contact: Rene J Hawkes, BS    206-287-2073    hawkes.r@ghc.org   
Principal Investigator: Daniel Cherkin, PhD         
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Daniel Cherkin, PhD Group Health Cooperative
  More Information

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT01467843     History of Changes
Other Study ID Numbers: 1R01AT006226-01A1
Study First Received: November 7, 2011
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Cognitive Behavioral Therapy
Mindfulness Based Stress Reduction

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014