OPAL: a randomised, placebo-controlled trial of opioid analgesia for the discount of ache severity in folks with acute spinal ache. Trial protocol.
BMJ Open. 2016 Aug 24;6(eight):e011278
Authors: Lin CW, McLachlan AJ, Latimer J, Day RO, Billot L, Koes BW, Maher CG
INTRODUCTION: Low again ache and neck ache are extraordinarily prevalent and are liable for an unlimited burden of illness globally. Robust analgesics, reminiscent of opioid analgesics, are really useful by scientific pointers for folks with acute low again ache or neck ache who’re gradual to get better and require extra ache reduction. Opioid analgesics are broadly and more and more used, however there are not any sturdy efficacy knowledge supporting the usage of opioid analgesics for acute low again ache or neck ache. Considerations relating to opioid use are additional heightened by the dangers of adversarial occasions, a few of which could be severe (eg, dependency, misuse and overdose).
METHODS AND ANALYSIS: OPAL is a randomised, placebo-controlled, triple-blinded trial that can examine the even handed use of an opioid analgesic in 346 individuals with acute low again ache and/or neck ache who’re gradual to get better. Contributors shall be recruited from normal follow and randomised to obtain the opioid analgesic (managed launch oxycodone plus naloxone as much as 20?mg per day) or placebo along with guideline-based care (eg, reassurance and recommendation of staying lively) for as much as 6?weeks. Contributors shall be followed-up for three?months for effectiveness outcomes. The first end result shall be ache severity. Secondary outcomes will embrace bodily functioning and time to restoration. Medicine-related adversarial occasions shall be assessed and a cost-effectiveness evaluation shall be performed. We’ll moreover assess long-term use and danger of misuse of opioid analgesics for as much as 12?months.
ETHICS AND DISSEMINATION: Moral approval has been obtained. Trial outcomes shall be disseminated by publications and convention displays, and through the media.
TRIAL REGISTRATION NUMBER: ACTRN12615000775516: Pre-results.
PMID: 27558901 [PubMed – indexed for MEDLINE]