Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
1 other identifier
interventional
342
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 low-back-pain
Started Jun 2012
Longer than P75 for phase_3 low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 13, 2017
October 1, 2017
3.4 years
November 7, 2011
October 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
26 weeks
Study Arms (3)
Cognitive Behavioral Therapy
ACTIVE COMPARATORParticipants randomized to the CBT intervention will attend eight weekly 2 hour sessions.
Mindfulness-Based Stress Reduction
ACTIVE COMPARATORParticipants randomized to the MBSR arm will attend eight weekly 2 hour MBSR sessions.
Usual Care
NO INTERVENTIONParticipants randomized to Usual Care will continue to receive care for their low back pain as prescribed by his/her Primary Care Physician.
Interventions
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.
Eligibility Criteria
You may qualify if:
- clinical Diagnosis of Low Back Pain lasting at least 3 months
- pain of at least 4 on a 0-10 bothersomeness scale
You may not qualify if:
- 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)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Group Health Cooperative
Seattle, Washington, 98101, United States
Related Publications (3)
Chen JA, Anderson ML, Cherkin DC, Balderson BH, Cook AJ, Sherman KJ, Turner JA. Moderators and Nonspecific Predictors of Treatment Benefits in a Randomized Trial of Mindfulness-Based Stress Reduction vs Cognitive-Behavioral Therapy vs Usual Care for Chronic Low Back Pain. J Pain. 2023 Feb;24(2):282-303. doi: 10.1016/j.jpain.2022.09.014. Epub 2022 Sep 28.
PMID: 36180008DERIVEDCherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
PMID: 27002445DERIVEDCherkin DC, Sherman KJ, Balderson BH, Turner JA, Cook AJ, Stoelb B, Herman PM, Deyo RA, Hawkes RJ. Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial. Trials. 2014 Jun 7;15:211. doi: 10.1186/1745-6215-15-211.
PMID: 24906419DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Cherkin, PhD
Kaiser Permanente
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
November 9, 2011
Study Start
June 1, 2012
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
October 13, 2017
Record last verified: 2017-10