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Cited by 39Musculoskeletal pain and rehabilitationMindfulness and Compassion InterventionsPain Management and Treatment

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

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Cherkin, Daniel C, Sherman, Karen J, Balderson, Benjamin H, Turner, Judith A, Cook, Andrea J, Stoelb, Brenda, Herman, Patricia M, Deyo, Richard A +1 more·2014·Trials
DOI 10.1186/1745-6215-15-211PMC PMC4052284
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Abstract

BACKGROUND: The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. METHODS/DESIGN: In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. DISCUSSION: If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01467843.

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  • For Cherkin 2014, incomplete outcome data was at low risk of bias.

    “Attrition > 10% but ITT analysis with imputation of missing values”

    From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Cherkin 2014

    The Methods/Design > Statistical analyses section plans an intent-to-treat approach and imputation as a sensitivity analysis, which supports part of the citing sentence. But this is a protocol: it anticipates at least 89% follow-up, does not report actual attrition above 10%, and specifies complete-case primary analysis rather than primary analysis with imputed missing values. It therefore does not establish a low-risk-of-bias judgment for incomplete outcome data. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • For Cherkin 2014, treatment expectations was at low risk of bias.

    “Expectations assessed and are similar at baseline, although group differences not discussed”

    From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Cherkin 2014

    The Methods/Design > Measures table (page unavailable) lists treatment expectations as a baseline measure. But this is a trial protocol: our copy does not report baseline results showing that expectations were similar across groups. It therefore supports the assessment part, not the stated group similarity or the resulting low-risk judgment. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • For Cherkin 2014, random sequence generation was at low risk of bias.

    “Participants were randomized within these strata in blocks of 3, 6, or 9. The stratified randomization sequence was generated by the study biostatistician using R statistical software”

    From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Cherkin 2014

    The Methods/Design > Randomization section describes a planned computer-generated random sequence with varying block sizes of three, six, or nine, supporting a low-risk assessment for sequence generation. It does not say that the study biostatistician generated the sequence using R, and as a protocol it describes the planned method rather than confirming its implementation. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • For Cherkin 2014, allocation concealment was at unclear risk of bias.

    “...sequence was stored in the study recruitment database and concealed from study staF until randomization.”

    From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Cherkin 2014

    The Methods/Design > Randomization passage (page unavailable) describes a computer-generated sequence and a program that prevents changing allocations after randomization. It does not state whether the sequence was concealed from study staff before randomization or assess allocation concealment as an unclear risk of bias. Searches for the recruitment-database wording and the risk assessment found no such passage. (LLM, conf=0.73)

    Experimental — accuracy not yet measured

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Authors
Cherkin, D. C., Sherman, K. J., Balderson, B. H., Turner, J. A., Cook, A. J., Stoelb, B., Herman, P. M., Deyo, R. A., & Hawkes, R. J.
Affiliations
  • Kaiser Permanente Washington Health Research Institute (US)
  • University of Washington (US)
  • RAND Corporation (US)
  • Oregon Health & Science University (US)
Corresponding author
Cherkin, Daniel C
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2014-06-07
Volume
15
Issue
1
Pages
211-211
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/1745-6215-15-211
PMC
PMC4052284
OpenAlex
W2115016128
Cited by
39
References
35
Citations by year
2026: 2 · 2025: 1 · 2024: 3 · 2023: 2 · 2022: 9 · 2021: 4 · 2020: 2 · 2019: 2 · 2018: 3 · 2017: 4 · 2016: 4 · 2015: 2
FWCI
2.43
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Trials (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • National Center for Complementary and Alternative Medicine
  • National Center for Complementary and Integrative Health (R01AT006226)
Topics
  • Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
Keywords
chronic back pain, mindfulness-based stress reduction, cognitive behavioral therapy, mind-body interventions, complementary and alternative medicine, psychosocial factors, pain beliefs, cost-effectiveness, group therapy
MeSH terms
Adult, Aged, Complementary Therapies, Back Pain, Cost-Benefit Analysis, Follow-Up Studies, Humans, Middle Aged, Research Design, Stress, Psychological, Cognitive Behavioral Therapy, Outcome Assessment, Health Care, Mind-Body Therapies, Young Adult, Chronic Pain, Mindfulness

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