Does Cognitive Functional Therapy Reduce the Amount of Opioids Dispensed for Chronic Low Back Pain Over 12 Months: A Secondary Analysis From the RESTORE Trial

BACKGROUND: Given the potential harms associated with opioids, interventions that can safely and effectively reduce the persistent use of opioids are important. Biopsychosocial interventions including Cognitive Functional Therapy (CFT) are effective for reducing chronic low back pain (LBP) and associated disability; however, it is unclear if they are effective at reducing or preventing new opioid use. The aim of this study was to investigate whether CFT with or without biofeedback changed the amount of opioid dispensed over 12-months compared to usual care in people with chronic, non-specific LBP. METHODS: This study is a secondary analysis of the RESTORE trial (n = 492) which randomly allocated participants with chronic LBP to one of three groups (CFT only, CFT-plus-biofeedback; usual care). This analysis included 301 participants who consented to their Pharmaceutical Benefits Scheme data being used (CFT only n = 107; CFT-plus-biofeedback n = 106; usual care n = 88). The primary outcome was average morphine equivalent dose per day dispensed during each quarter in the first 12 months of the trial. The secondary outcome was the proportion of participants that had any opioids dispensed during each quarter. RESULTS: There was only a small percentage of participants taking opioids and we did not find any statistically or clinically significant differences between the two CFT groups and the usual care group (p ≥ 0.140) for either outcome. Clinical improvements in pain and disability following a biopsychosocial intervention do not necessarily lead to a reduction in opioids dispensed. Interventions targeting opioid reduction may be required to reduce the use of opioids in this population. SIGNIFICANCE STATEMENT: There is growing evidence that Cognitive Functional Therapy (CFT) is effective for reducing chronic low back pain and associated disability; however, no previous trials have investigated if CFT is also effective at reducing opioid use. This randomised controlled trial found CFT was not effective in reducing opioid use in people with chronic low back pain, despite it having large effects on pain and activity limitation.