PEACE study: psychophysical enhancement to augment conservative and epidural steroid injection outcomes: a multi-center international randomized trial

Background Low back pain (LBP) is the leading cause of disability worldwide, with epidural steroid injections (ESI) being the most commonly performed procedure. High-quality studies demonstrate conflicting evidence for efficacy, with the placebo effect, which is contingent on expectations and framing, being higher than intrinsic effects. The objectives of this trial are to determine the effect of procedural framing on ESI outcomes, and which patient subgroup(s) might benefit from ‘positive’ framing.Methods This multinational, randomized trial will allocate 280 patients with lumbosacral radiculopathy in a 2:2:1 ratio to positive framing of ESI before the procedure, and neutral framing of both ESI and pharmacotherapy. The primary outcome is reduction in average leg pain 4-weeks post-intervention. Those with a positive outcome, defined as >30% decrease in average leg pain coupled with a score >4/7 on a Patient Global Impression of Change scale, will follow-up at 12 weeks. A host of clinical, demographic (including military status) and psychological variables (optimism, expectations, psychopathology, personality type) will be analyzed for their effect on outcomes.Discussion This study will be the first to determine whether positive educational framing of a pain intervention can improve outcomes, which has the potential to dramatically improve risk:benefit and cost:effectiveness ratios.Clinical Trial Registration www.clinicaltrials.gov identifier is NCT07498140.