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

NCT ID: NCT01467843

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-11-30

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Keywords

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Cognitive Behavioral Therapy Mindfulness Based Stress Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Behavioral Therapy

Participants randomized to the CBT intervention will attend eight weekly 2 hour sessions.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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.

Mindfulness-Based Stress Reduction

Participants randomized to the MBSR arm will attend eight weekly 2 hour MBSR sessions.

Group Type ACTIVE_COMPARATOR

Mindfulness Based Stress Reduction

Intervention Type BEHAVIORAL

The Mindfulness Based Stress Reduction Classes will be delivered in 8 weekly classes each lasting 2 hours.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Mindfulness Based Stress Reduction

The Mindfulness Based Stress Reduction Classes will be delivered in 8 weekly classes each lasting 2 hours.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Cherkin, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Group Health Cooperative

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36180008 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27002445 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24906419 (View on PubMed)

Other Identifiers

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1R01AT006226-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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