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

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. 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. 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. www.clinicaltrials.gov identifier is NCT07498140. This study, whose source of funding is from the U.S. Department of Defense and Thai Ministry of Defence, seeks to determine whether how the procedure is presented (framed) can improve treatment results for epidural steroid injections (ESI) for sciatica. Two hundred eighty patients with sciatica will be randomized (as if by coin flip) in a 2:2:1 ratio to receive an ESI with positive framing, an ESI with neutral framing, and medications with neutral framing, with the latter two as comparators. The main outcome measure is the average reduction in leg pain, with a positive outcome considered to be a 30% or greater decrease in leg pain and being satisfied with the results. Because how a treatment is presented can influence the placebo effect, we will also examine whether characteristics that could affect the placebo response such as personality type, optimism and expectations, are associated with outcomes.