EBQ:SPACE Trial
Krebs et al.. 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. JAMA 2018. 319:872-882. PMID: 29509867. DOI. Full Text.
Clinical Question
To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects.
Bottom Line
A landmark study was published in 2018 by Krebs et al - the SPACE study. It was a pragmatic randomised controlled trial comparing opioid versus non opioid analgesics for 12 months in primary care. Participants were 240 VA patients with moderate to severe chronic back pain or knee/hip OA, and not on opioids. The mean pain intensity initially was 5.4 in both arms. Pain scores at 1 year was worse in the opioid arm (4.0) than non opioid (3.5) (P=0.034). There was no difference in pain interference, and adverse effects were worse in opioid group (P=0.03).
Brief Pain Inventory (BPI) over 12 months
Pain Interference over 12 months
Study Design
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 randomised.
Population Studied
Inclusion Criteria
Eligible patients had chronic back pain or hip or knee osteoarthritis pain that was moderate to severe despite analgesic use. Chronic pain was defined as pain nearly every day for 6 months or more. Moderate or greater severity was defined by a score of 5 or more on the 3-item pain intensity, interference with enjoyment of life, and interference with general activity (PEG) scale (range, 0-10).
Exclusion Criteria
Patients on long-term opioid therapy were excluded. Other reasons for exclusion included contraindications to all drug classes in either group, including class-level opioid contraindications (eg, active substance use disorder), and conditions that could interfere with outcome assessment (eg, life expectancy <12 months). Patients with severe depression or posttraumatic stress disorder symptoms were not excluded because these patients often receive opioids in practice.
