Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Mindfulness Based Stress Reduction
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Cognitive Behavioral Therapy, Mindfulness Based Stress Reduction
Eligibility 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
Sites / Locations
- Group Health Cooperative
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Cognitive Behavioral Therapy
Mindfulness-Based Stress Reduction
Usual Care
Arm Description
Participants randomized to the CBT intervention will attend eight weekly 2 hour sessions.
Participants randomized to the MBSR arm will attend eight weekly 2 hour MBSR sessions.
Participants randomized to Usual Care will continue to receive care for their low back pain as prescribed by his/her Primary Care Physician.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01467843
First Posted
November 7, 2011
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01467843
Brief Title
Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
Official Title
Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Cognitive Behavioral Therapy, Mindfulness Based Stress Reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Participants randomized to the CBT intervention will attend eight weekly 2 hour sessions.
Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Active Comparator
Arm Description
Participants randomized to the MBSR arm will attend eight weekly 2 hour MBSR sessions.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized to Usual Care will continue to receive care for their low back pain as prescribed by his/her Primary Care Physician.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
The Mindfulness Based Stress Reduction Classes will be delivered in 8 weekly classes each lasting 2 hours.
Primary Outcome Measure Information:
Title
Back pain-related dysfunction
Description
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
Title
Bothersomeness of back pain
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Cherkin, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Cooperative
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36180008
Citation
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.
Results Reference
derived
PubMed Identifier
27002445
Citation
Cherkin 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.
Results Reference
derived
PubMed Identifier
24906419
Citation
Cherkin 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.
Results Reference
derived
Learn more about this trial
Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
We'll reach out to this number within 24 hrs