Strategies to Assist With Management of Pain
CompletedNot applicableNCT03115359
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 will be randomly assigned into one of two 8-week treatment groups: MM (383 …
Study details
- Official title
- A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation Versus Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain
- Conditions
- Interventions
- Behavioral: Mindfulness Based Therapy
- Behavioral: Cognitive Behavioral Therapy
- Sponsor
- University of Wisconsin, Madison
- Collaborators
- Patient-Centered Outcomes Research Institute
- Start date
- 2017-06-30
- Primary completion
- 2023-01-15
- Sex
- All
- Age range
- from 21 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03115359