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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
---|---|
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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Responsible Party: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT01467843 |
Other Study ID Numbers: |
1R01AT006226-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | November 9, 2011 Key Record Dates |
Last Update Posted: | October 13, 2017 |
Last Verified: | October 2017 |
Cognitive Behavioral Therapy Mindfulness Based Stress Reduction |
Back Pain Low Back Pain Pain Neurologic Manifestations |