NCT07498140

Procedural Framing and Epidural Steroid Injection Outcomes

The Effect of Procedural Framing on Epidural Steroid Injection Outcomes: A Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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 than an interlaminar injection for bilateral pain), as well as possible differences in side effects. For the 84 individuals randomized to the study group (positive framing of ESI), the investigators will provide 5 slides with bullet points and images outlining peer-reviewed studies, reviews and guidelines on ESI that present the treatment in a more positive light (consistent with the views of most people who perform ESIs), but still consistent with evidence. These slides will contain references to high-quality articles and there will be an investigator present to answer questions. There is a very wide range in how a procedure is presented to patients, and this framework is consistent with how ESI are presented to patients by pain practitioners from all over the world. This material is all publicly available but has been compiled in presentation form. For the 84 individuals in the ESI control group, the investigative team will provide a 1-slide overview on ESI that is slightly less optimistic, consistent with how many non-pain-physicians view ESI including that the evidence for surgery reduction is questionable. For the 42 individuals in the active control group who will receive a first-line medication for neuropathic and non-structured instructions to exercise, the investigators will provide a 1-side overview that presents the raw, neutral facts on adjuvants for sciatica (some guidelines recommend them, others do not, but some recommend a trial of conservative care for back pain before interventions; there are no medications across the globe approved for lumbosacral radiculopathy).

Conditions

• Lumbosacral Radiculopathy

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral manipulation of ESI expectations	5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.
OTHER	No behavioral manipulation of ESI expectations	1-slide summary of ESI portrayed in a neutral light.
OTHER	No behavioral manipulation of pharmacotherapy expectations	1-slide summary of medications for neuropathic pain portrayed in a neutral light.

Timeline

• Start date: 2026-03-25
• Primary completion: 2028-03-25
• Completion: 2028-06-30
• First posted: 2026-03-27
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States