Strategies to Assist With Management of Pain

Description

Chronic low back pain (CLBP) has no known effective treatment. While often treated with long-term opioid therapy, opioids do not work well for many patients and can cause serious side effects, including addiction, poorer mental health, and overdose death. Even when paired with a standard-of-care cognitive behavioral therapy (CBT), results are limited. Patients, families and clinicians are very interested in using alternative treatments for CLBP, especially complementary and integrative treatments such as mindfulness meditation (MM). MM helps train the mind to bring non-judgmental and accepting attention to present-moment experiences such as pain. MM offers an active and safe self-care approach to chronic pain that contrasts with the passive and potentially harmful nature of opioid treatment, and may prove more effective than CBT in helping improve health and well-being, and reduce reliance on opioids in adults with opioid-treated CLBP. Although this hypothesis is supported by early research, including a pilot study by the Principal Investigator, evidence on MM's effectiveness in this population is inconclusive, presenting a critical knowledge gap. With input from patients, family members, and clinicians, the Investigators have designed a study to address this gap and propose a clinical trial that will compare the effectiveness of MM to standard-of-care CBT in opioid-treated CLBP. Based on the existing research, it is hypothesized that MM training will lead to a larger reduction in pain intensity, increase in physical function, improvement in quality of life, and decrease in daily opioid dose, as compared to CBT training, with benefits of MM especially notable in adults with worse mood, anxiety or unhealthy opioid-use behaviors who often experience more severe symptoms of CLBP and less improvement in response to existing therapies. To test these hypotheses, 766 adults with opioid-treated CLBP from Madison, WI, Boston, MA, and Salt Lake City, will be randomly assigned into one of two 8-week treatment groups: MM (383 participants) that will receive the MM training or CBT (383 participants) that will receive the CBT training. The effectiveness of MM versus CBT will be assessed over a 12-month period with patient-reported measures, recommended by experts and endorsed by our stakeholder partners, including patients with opioid-treated CLBP, their families and clinicians.

Study Start Date

June, 30 2017

Estimated Completion Date

July 2021

Interventions

  • Behavioral: Cognitive Behavioral Therapy
  • Behavioral: Mindfulness Meditation

Study ID

University of Wisconsin, Madison -- 2017-0353

Status

Recruiting

Trial ID

NCT03115359

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

766

Sponsor

University of Wisconsin, Madison

Inclusion Criteria (per self-report): English-speaking age ? 21 years old chronic low back pain (defined as a pain in lumbosacral region or sciatica for ?3 months), with an average daily back pain score ?3 on a 0-10 numerical rating scale (question from the Brief Pain Inventory), treated with ?30 mg/day of morphine-equivalent dose for ?3 months at least moderate CLBP-related disability (?21 score on the Oswestry Disability Index) capable of giving informed consent willing to complete the study activities. Exclusion Criteria (per self-report): prior formal Mindfulness Meditation or Cognitive Behavioral Therapy training current pregnancy diagnosis of borderline personality, delusional, or bipolar (mania) disorder inability to safely or reliably participate in the study.

Gender

All

Ages

21 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (18)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Christina McDonnell MSc 617-732-9181 crmcdonnell@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Christina McDonnell MSc 617-732-9181 crmcdonnell@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Christina McDonnell MSc 617-732-9181 crmcdonnell@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Christina McDonnell MSc 617-732-9181 crmcdonnell@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Christina McDonnell MSc 617-732-9181 crmcdonnell@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Christina McDonnell MSc 617-732-9181 crmcdonnell@bwh.harvard.edu
University of WisconsinMadison - Madison, Wisconsin 930.4 miles Cindy A Burzinski MS 608-262-6549 cindy.burzinski@fammed.wisc.edu
University of WisconsinMadison - Madison, Wisconsin 930.4 miles Cindy A Burzinski MS 608-262-6549 cindy.burzinski@fammed.wisc.edu
University of WisconsinMadison - Madison, Wisconsin 930.4 miles Cindy A Burzinski MS 608-262-6549 cindy.burzinski@fammed.wisc.edu
University of WisconsinMadison - Madison, Wisconsin 930.4 miles Cindy A Burzinski MS 608-262-6549 cindy.burzinski@fammed.wisc.edu
University of WisconsinMadison - Madison, Wisconsin 930.4 miles Cindy A Burzinski MS 608-262-6549 cindy.burzinski@fammed.wisc.edu
University of WisconsinMadison - Madison, Wisconsin 930.4 miles Cindy A Burzinski MS 608-262-6549 cindy.burzinski@fammed.wisc.edu
University of Utah - Salt Lake City, Utah 2,094.1 miles Rachel Atchley PhD 801-581-8489 rachel.atchley@utah.edu
University of Utah - Salt Lake City, Utah 2,094.1 miles Rachel Atchley PhD 801-581-8489 rachel.atchley@utah.edu
University of Utah - Salt Lake City, Utah 2,094.1 miles Rachel Atchley PhD 801-581-8489 rachel.atchley@utah.edu
University of Utah - Salt Lake City, Utah 2,094.1 miles Rachel Atchley PhD 801-581-8489 rachel.atchley@utah.edu
University of Utah - Salt Lake City, Utah 2,094.1 miles Rachel Atchley PhD 801-581-8489 rachel.atchley@utah.edu
University of Utah - Salt Lake City, Utah 2,094.1 miles Rachel Atchley PhD 801-581-8489 rachel.atchley@utah.edu

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