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

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ClinicalTrials.gov Identifier: NCT01467843

Recruitment Status : Completed

First Posted : November 9, 2011

Last Update Posted : October 13, 2017

Sponsor:

Collaborator:

National Center for Complementary and Integrative Health (NCCIH)

Information provided by (Responsible Party):

Kaiser Permanente

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Behavioral: Cognitive Behavioral Therapy Behavioral: Mindfulness Based Stress Reduction	Phase 3

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.

Study Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Kaiser Permanente

National Center for Complementary and Integrative Health (NCCIH)

Investigators


Principal Investigator:	Daniel Cherkin, PhD	Kaiser Permanente

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT01467843 History of Changes
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

Keywords provided by Kaiser Permanente:


Cognitive Behavioral Therapy Mindfulness Based Stress Reduction

Additional relevant MeSH terms:


Back Pain Low Back Pain Pain	Neurologic Manifestations Nervous System Diseases Signs and Symptoms

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