Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain
|ClinicalTrials.gov Identifier: NCT01467843|
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Behavioral: Cognitive Behavioral Therapy Behavioral: Mindfulness Based Stress Reduction||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||342 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Active Comparator: Cognitive Behavioral Therapy
Participants randomized to the CBT intervention will attend eight weekly 2 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 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467843
|United States, Washington|
|Group Health Cooperative|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Daniel Cherkin, PhD||Kaiser Permanente|