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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01467843
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE November 7, 2011
First Posted Date  ICMJE November 9, 2011
Last Update Posted Date October 13, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
  • Back pain-related dysfunction [ Time Frame: 26 weeks ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2011)
  • Back pain-related dysfunction [ Time Frame: 10-weeks ]
    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: 10 weeks ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
Official Title  ICMJE Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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.
  • Behavioral: Mindfulness Based Stress Reduction
    The Mindfulness Based Stress Reduction Classes will be delivered in 8 weekly classes each lasting 2 hours.
Study Arms  ICMJE
  • Active Comparator: Cognitive Behavioral Therapy
    Participants randomized to the CBT intervention will attend eight weekly 2 hour sessions.
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • Active Comparator: Mindfulness-Based Stress Reduction
    Participants randomized to the MBSR arm will attend eight weekly 2 hour MBSR sessions.
    Intervention: Behavioral: Mindfulness Based Stress Reduction
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2015)
342
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2011)
297
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01467843
Other Study ID Numbers  ICMJE 1R01AT006226-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kaiser Permanente
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kaiser Permanente
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Daniel Cherkin, PhD Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP