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Original Research|Articles in Press

Mindfulness-Based Interdisciplinary Pain Management Program for Complex Polymorbid Pain in Veterans: A Randomized Clinical Trial

Published:August 05, 2022DOI:https://doi.org/10.1016/j.apmr.2022.06.012
Mindfulness-Based Interdisciplinary Pain Management Program for Complex Polymorbid Pain in Veterans: A Randomized Clinical Trial
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      Abstract

      Objective

      To evaluate the effects of interdisciplinary pain management on pain-related disability and opioid reduction in polymorbid pain patients with two or more comorbid psychiatric conditions.

      Design

      Two-arm randomized clinical trial testing a three-week intervention with assessments at pre-treatment, post-treatment, 6-month and 12-month follow-up.

      Setting

      Department of Veterans Affairs medical facility.

      Participants

      103 military veterans with moderate (or worse) levels of pain-related disability, depression, anxiety, and/or PTSD randomly assigned to usual care (n=53) and interdisciplinary pain management (n=50). All participants reported recent persistent opioid use. Trial participants had high levels of comorbid medical and mental health conditions.

      Interventions

      Experimental arm – a three-week, interdisciplinary pain management program guided by a structured manual; Comparison arm – usual care in a large VA medical facility.

      Main Outcome Measures

      Oswestry Disability Index (pain disability); Timeline Followback Interview and Medication Event Monitoring System (opioid use). Analysis used generalized linear mixed model with all posttreatment observations (posttreatment, 6-month follow-up, 12-month follow-up) entered simultaneously to create a single posttreatment effect.

      Results

      Veterans with polymorbid pain randomized to the interdisciplinary pain program reported significantly greater decreases in pain-related disability compared to veterans randomized to treatment as usual (TAU) at posttreatment, 6-month and 12-month follow-up. Aggregated mean pain disability scores (i.e., a summary effect of all posttreatment observations) for the interdisciplinary pain program were -9.1 (95% CI: -14.4, -3.7, P = .001) points lower than TAU. There was no difference between groups in the proportion of participants who resumed opioid use during trial participation (32% in both arms).

      Conclusion

      These findings offer the first evidence of short- and long-term interdisciplinary pain management efficacy in polymorbid pain patients, but more work is needed to examine how to effectively decrease opioid use in this population.

      Keywords

      List of abbreviations:

      CIH (Complementary and Integrative Health), DoD (Department of Defense), FORT-A (Functional Orthopedic Rehabilitation Treatment), GAD-7 (7-item generalized anxiety disorder screener), GLMM (generalized linear mixed model(s)), IPMC (interdisciplinary pain management center), ITT (intent-to-treat), MEMS (Medication Event Monitoring System), ODI (Oswestry Disability Index), PCL-5 (PTSD Checklist for the DSM-5), PHQ-9 (9-Item Patient Health Questionnaire depression screener), PRIME-MD (Primary Care Evaluation of Mental Disorders), PTSD (posttraumatic stress disorder), SMD (standardized mean difference), TAU (treatment as usual), TLFB (Timeline Follow-back Interview), TBI (traumatic brain injury), Tx (treatment), VA (Department of Veterans Affairs)
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      Article Info

      Publication History

      Accepted: June 21, 2022
      Received in revised form: June 15, 2022
      Received: January 27, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Trial Funding: The work described in this manuscript was funded under an award from the National Center for Complementary and Integrative Health (Award R01 AT008422-01; PI: D. McGeary).

      Trial Registration: This trial was registered on ClinicalTrials.gov on January 15, 2016; ClinicalTrials.gov Identifier: NCT02657317; the first participant was enrolled in June 2016.

      Presentations: The outcomes of this trial have not been presented in any other forum through any format.

      Acknowledgments and Conflict of Interest: The authors would like to acknowledge Mr. Ray Aguilar for technical assistance, Ms. Deanne Hargita for assistance with regulatory approvals, Ms. Briana Cobos for assistance with data organization, and Mrs. Julie Collins for assistance editing this manuscript. The work described in this manuscript was funded under an award from the National Center for Complementary and Integrative Health (Award R01 AT008422-01; PI: D. McGeary) and supported the work of authors DM, CJ, BE, TB, PN, JM, MJP, TH, JSP, SYM, ALP, MS and CM on this project. The views expressed herein are solely those of the authors and do not represent an endorsement by or the official policy or position of the Department of Veterans Affairs, the National Institutes of Health, or the U.S. Government. The data and analytic code in R that were used for these analyses are available upon request to the corresponding author.

      Identification

      DOI: https://doi.org/10.1016/j.apmr.2022.06.012

      Copyright

      © 2022 Published by Elsevier Inc. on behalf of the American Congress of Rehabilitation Medicine

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