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      Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain : The SPACE Randomized Clinical Trial

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          Key Points

          Question

          For patients with moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use, does opioid medication compared with nonopioid medication result in better pain-related function?

          Findings

          In this randomized clinical trial that included 240 patients, the use of opioid vs nonopioid medication therapy did not result in significantly better pain-related function over 12 months (3.4 vs 3.3 points on an 11-point scale at 12 months, respectively).

          Meaning

          This study does not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.

          Abstract

          Importance

          Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain.

          Objective

          To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects.

          Design, Setting, and Participants

          Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016. Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use. Of 265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized.

          Interventions

          Both interventions (opioid and nonopioid medication therapy) followed a treat-to-target strategy aiming for improved pain and function. Each intervention had its own prescribing strategy that included multiple medication options in 3 steps. In the opioid group, the first step was immediate-release morphine, oxycodone, or hydrocodone/acetaminophen. For the nonopioid group, the first step was acetaminophen (paracetamol) or a nonsteroidal anti-inflammatory drug. Medications were changed, added, or adjusted within the assigned treatment group according to individual patient response.

          Main Outcomes and Measures

          The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months and the main secondary outcome was pain intensity (BPI severity scale). For both BPI scales (range, 0-10; higher scores = worse function or pain intensity), a 1-point improvement was clinically important. The primary adverse outcome was medication-related symptoms (patient-reported checklist; range, 0-19).

          Results

          Among 240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial. Groups did not significantly differ on pain-related function over 12 months (overall P = .58); mean 12-month BPI interference was 3.4 for the opioid group and 3.3 for the nonopioid group (difference, 0.1 [95% CI, −0.5 to 0.7]). Pain intensity was significantly better in the nonopioid group over 12 months (overall P = .03); mean 12-month BPI severity was 4.0 for the opioid group and 3.5 for the nonopioid group (difference, 0.5 [95% CI, 0.0 to 1.0]). Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]).

          Conclusions and Relevance

          Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.

          Trial Registration

          clinicaltrials.gov Identifier: NCT01583985

          Abstract

          This randomized clinical trial compares the effects of opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects among Veterans Affairs patients with moderate to severe chronic back pain or hip or knee osteoarthritis pain.

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          Author and article information

          Journal
          JAMA
          JAMA
          JAMA
          JAMA
          American Medical Association
          0098-7484
          1538-3598
          6 March 2018
          6 March 2018
          6 September 2018
          : 319
          : 9
          : 872-882
          Affiliations
          [1 ]Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota
          [2 ]Department of Medicine, University of Minnesota Medical School, Minneapolis
          [3 ]Division of Epidemiology, University of Minnesota School of Public Health, Minneapolis, Minneapolis, Minnesota
          [4 ]Center for Health Information and Communication, Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana
          [5 ]Department of Medicine, Indiana University School of Medicine, Indianapolis
          [6 ]Regenstrief Institute, Indianapolis, Indiana
          Author notes
          Article Information
          Corresponding Author: Erin E. Krebs, MD, MPH, Minneapolis Veterans Affairs Health Care System (152), 1 Veterans Dr, Minneapolis, MN 55417 ( erin.krebs@ 123456va.gov ).
          Accepted for Publication: February 2, 2018.
          Author Contributions: Dr Krebs had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
          Concept and design: Krebs, Kroenke, Bair.
          Acquisition, analysis, or interpretation of data: All authors.
          Drafting of the manuscript: Krebs, Jensen, DeRonne, Bair.
          Critical revision of the manuscript for important intellectual content: Gravely, Nugent, DeRonne, Goldsmith, Kroenke, Bair, Noorbaloochi.
          Statistical analysis: Gravely, Noorbaloochi.
          Obtained funding: Krebs, Kroenke, Bair.
          Administrative, technical, or material support: Nugent, Jensen, DeRonne, Goldsmith.
          Supervision: Krebs, Kroenke.
          Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Ms Jensen reported that her spouse is employed as a research chemist by Upsher-Smith Laboratories. No other disclosures are reported
          Funding/Support: This trial was funded by the Merit Review Award (I01-HX-000671) from the US Department of Veterans Affairs Health Services Research and Development Service.
          Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
          Disclaimer: The views expressed in this article are those of the authors and do not represent the views of the VA or the US government.
          Additional Contributions: We thank the veterans who participated in the trial; our Minneapolis VA Health Care System primary care colleagues; members of the data and statistics monitoring board and institutional review board. We also thank the members of the research team, including Indulis Rutks, BS, David Leverty, BS, Ruth Balk, BA, Erin Linden, MPH, and Andrea Cutting, MA (all from Minneapolis VA Health Care System). They received compensation for their contribution. We also thank Melvin Donaldson, MS (University of Minnesota), for help with recruitment; Preetanjali Thakur, BDS (University of Minnesota), for reviewing adverse events; Elzie Jones, PharmD, Melissa Bell, PharmD, Howard Fink, MD, MPH, and Steven Fu, MD, MSCE (all from Minneapolis VA Health Care System), for providing clinical coverage; and Doug DeCarolis, PharmD (Minneapolis VA Health Care System), for dispensing research medication. They did not receive compensation for their contribution.
          Article
          PMC5885909 PMC5885909 5885909 joi180013
          10.1001/jama.2018.0899
          5885909
          29509867
          48e3b27a-8cfb-44d1-9297-c15891d0294e
          Copyright 2018 American Medical Association. All Rights Reserved.
          History
          : 25 October 2017
          : 29 January 2018
          : 1 February 2018
          Funding
          Funded by: US Department of Veterans Affairs Health Services Research and Development Service
          Categories
          Research
          Research
          Original Investigation

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