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.

Details

• Personal Author:
  Bair MJ ; DeRonne B ; Goldsmith ES ; Gravely A ; Jensen AC ; Krebs EE ; Kroenke K ; Noorbaloochi S ; Nugent S
• Description:
  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. [Description provided by NIOSH]
• Subjects:
  Biopharmaceutics Drug Therapy Musculoskeletal System Occupational Health Safety
• Keywords:
  Medical treatment; Drug therapy; Pharmaceuticals; Health care; Pain tolerance; Low back pain; Rheumatoid disorders; Clinical symptoms
• ISSN:
  0098-7484
• Document Type:
  Text
• Funding:
  Grant
• Genre:
  Journal Article
• Place as Subject:
  Indiana ; Minnesota ; OSHA Region 5 ; OSHA Region 6 ; Texas
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  319
• Issue:
  9
• NIOSHTIC Number:
  nn:20065300
• Citation:
  JAMA 2018 Mar; 319(9):872-882
• Contact Point Address:
  Erin E. Krebs, MD, MPH, Minneapolis Veterans Affairs Health Care System (152), 1 Veterans Dr, Minneapolis, MN 55417
• Email:
  erin.krebs@va.gov
• Federal Fiscal Year:
  2018
• Performing Organization:
  University of Texas Health Science Center, Houston
• Peer Reviewed:
  True
• Start Date:
  20050701
• Source Full Name:
  Journal of the American Medical Association
• End Date:
  20250630
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:f340bf7b0e5b2a158a02e8b30716504c7b7e91827e33e9e4f96d0bdbeee5ca26667ae02ae5d7e487542476ce4963af7f23caa94c01636d7b5dcf8e76c1eb822f
• Download URL:
  https://stacks.cdc.gov/view/cdc/249394/cdc_249394_DS1.pdf
• File Type:
  [PDF - 264.72 KB ]