PEACE Study: Psychophysical Enhancement to Augment Conservative and Epidural Steroid Injection Outcomes: A Multi-Center International Randomized Trial
Northwestern University
Summary
Back pain is the leading cause of disability and military medical boards across the globe. Epidural steroid injections (ESI) are the most commonly performed pain procedure in the world. There is strong evidence that the placebo effect for all pain treatments, including ESI, is greater than the intrinsic effect. The placebo effect is highly dependent on a patient's 'expectations', and therefore how the procedure is framed. This study aims to compare ESI when the procedure is framed very positively- as is often done in clinical practice vs. more neutrally (which is less commonly done in clinical practice but consistent with evidence). The placebo effect is also stronger for procedures than medications. The evidence on the benefits of ESI is highly dependent on whether it is compiled by interventional doctors who perform the procedure or non-interventional researchers. In order to determine how 'framing' a treatment affects pain outcomes, the investigative team will conduct a 3-arm randomized trial comparing positive framing of ESI, neutral framing of ESI, and medications, in patients with lumbosacral radiculopathy.
Description
Two hundred and ten eligible individuals will be randomized in blocks of 10 in a 2:2:1 ratio to receive positive framing for ESI (treatment group), neutral framing for ESI (control group), or pharmacological therapy and instructions to exercise (active control group), respectively. There will suballocation based on whether the patient has unilateral or bilateral pain (i.e., whether the participant would receive a transforaminal ESI or an interlaminar ESI, respectively). This is because there may be differences in outcomes (transforaminal injections for unilateral pain may be more effective tha…