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Cited by 18Musculoskeletal pain and rehabilitationMindfulness and Compassion InterventionsOpioid Use Disorder Treatment

Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: protocol for a pragmatic randomized controlled trial

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Zgierska, Aleksandra E., Burzinski, Cindy A., Garland, Eric L., Lennon, Robert P., Jamison, Robert, Nakamura, Yoshio, Barrett, Bruce, Sehgal, Nalini +5 more·2021·Contemporary Clinical Trials
DOI 10.1016/j.cct.2021.106548
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Abstract

Objective Chronic low back pain (CLBP) is disabling and costly. Existing therapies have proven suboptimal, with many patients resorting to long-term opioid therapy, which can cause harms. Cognitive behavioral (CBT) and mindfulness-based (MBT) therapies can be effective and offer unique skills for safe pain coping. This article describes the protocol for a study evaluating comparative effectiveness of CBT and MBT in adults with opioid-treated CLBP.Design Pragmatic, multi-center randomized controlled trial (RCT).Settings Community and outpatient care.Participants Planned enrollment of 766 adults (383/group) with CLBP treated with long-term opioids (≥3 months; ≥15 mg/day morphine-equivalent dose).Interventions CBT or MBT consisting of eight weekly therapist-led, two-hour group sessions, and home practice (≥30 min/day, 6 days/week) during the 12-month study.Main outcome measures Main outcome measures, collected by self-report at baseline, then three, six, nine and 12 months post-entry, include co-primary measures: pain intensity (Numeric Rating Scale) and function (Oswestry Disability Index), and secondary measures: quality of life (Medical Outcomes Study) and average daily opioid dose (Timeline Followback). Baseline scores of depression, anxiety, and opioid misuse questionnaires will be assessed as potential contributors to the heterogeneity of treatment response. Intention-to-treat, linear mixed-effects analysis will examine treatment effectiveness. Qualitative data will augment the quantitative measures.Conclusions This will be the largest RCT comparing CBT and MBT in opioid-treated CLBP. It will provide evidence on the impact of these interventions, informing clinical decisions about optimal therapy for safe, effective care, improving quality of life and decreasing opioid-related harm among adults with refractory CLBP.

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  • The study included 765 adults with opioid-treated chronic low back pain who completed the Current Opioid Misuse Measure (COMM) at baseline.

    “Of 770 adults with opioid-treated CLBP who enrolled in the larger RCT, 765 completed the Current Opioid Misuse Measure (COMM) at baseline27 and were included in the analysis.”

    From Risk Factors for Self-Harm Ideation among Persons Treated with Opioids for Chronic Low Back Pain (2023) · cites this paper as [27]

    Section 2.10.3 identifies COMM as a measure in this trial, and section 2.10 says participants complete a baseline assessment. The protocol does not report that 770 enrolled or that 765 completed COMM at baseline; it reports a sample-size goal of 766 in the “12-month exit visit” section. Page numbers are unavailable in our copy. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • There is a well-established relationship between increased emotional distress, increased pain sensitivity, and pain-related disability.

    “There is a well-established relationship between increased emotional distress, increased pain sensitivity, and pain-related disability,22”

    From Risk Factors for Self-Harm Ideation among Persons Treated with Opioids for Chronic Low Back Pain (2023) · cites this paper as [22]

    The Background (page not available) says that depression and anxiety commonly co-occur with chronic pain and that their severity can affect pain-treatment response. It does not state the claimed relationship among greater emotional distress, greater pain sensitivity, and pain-related disability. The outcome-measures section (page not available) measures pain and disability separately but does not establish that relationship. (LLM, conf=0.82)

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Research works printed but not linked: 3

  1. [10]10. J. Otis, Managing Chronic Pain: A Cognitive-Behavioral Therapy Approach Therapist Guide, Oxford University Press, New York, 2007.
  2. [12]12. M. Goyal, S. Singh, Sibinga EMS, N.F. Gould, A. Rowland-Seymour, R. Sharma, Z. Berger, D. Sleicher, D.D. Maron, H.M. Shihab, P.D. Ranasinghe, S. Linn, S. Saha, E.B. Bass, Haythornthwaite JA. Meditation Programs for Psychological Stress and Well-Being. Comparative Effectiveness Review No. 124. (Prepared by Johns Hopkins University Evidence-based Practice Center under Contract No. 290-2007- 10061-I.) AHRQ Publication No. 13
  3. [42]42. E.L. Garland, Mindfulness-Oriented Recovery Enhancement for Addiction, Stress, and Pain, NASW Press, Washington, DC, 2013.

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Authors
Zgierska, A. E., Burzinski, C. A., Garland, E. L., Lennon, R. P., Jamison, R., Nakamura, Y., Barrett, B., Sehgal, N., Mirgain, S. A., Singles, J. M., Cowan, P., Woods, D., & Edwards, R. R.
Affiliations
  • Pennsylvania State University (US)
  • University of Wisconsin–Madison (US)
  • University of Utah (US)
  • Brigham and Women's Hospital (US)
  • American Chronic Pain Association (US)
Corresponding author
Zgierska, Aleksandra E.
ORCID
Venue
Contemporary Clinical Trials
Publisher
Elsevier BV
Published
2021-11
Volume
110
Pages
106548
ISSN
1551-7144 (ISSN-L)
DOI
10.1016/j.cct.2021.106548
OpenAlex
W3197252316
Cited by
18
References
101
Citations by year
2026: 2 · 2025: 1 · 2024: 7 · 2023: 4 · 2022: 4
FWCI
2.19
Type
journal article
Language
en
Open access
Licence
Locations
  • Contemporary Clinical Trials (publishedVersion)
  • PubMed (publishedVersion)
  • ScholarSphere (Penn State Libraries) (submittedVersion)
Funders
  • University of Wisconsin-Madison
  • Institute for Clinical and Translational Research, University of Wisconsin, Madison
  • University of Utah
  • Patient-Centered Outcomes Research Institute (OPD-1601-33860)
  • School of Medicine and Public Health, University of Wisconsin-Madison
  • Pennsylvania State University
  • National Center for Advancing Translational Sciences (1UL1TR002373)
Topics
  • Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
Keywords
chronic low back pain, mindfulness-based interventions, cognitive behavioral therapy, opioid therapy, chronic opioid use, comparative effectiveness, pain intensity, disability, quality of life, opioid dose, opioid misuse, anxiety and depression, pain coping, opioid-related harms
MeSH terms
Adult, Analgesics, Opioid, Humans, Cognitive Behavioral Therapy, Randomized Controlled Trials as Topic, Low Back Pain, Chronic Pain, Pragmatic Clinical Trials as Topic, Mindfulness

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