The Effect of Procedural Framing on Epidural Steroid Injection Outcomes: A Randomized Controlled Study
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…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \> 18 * Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.) * Duration of pain \>6 weeks * NRS leg pain score \> 4 (or if 3/10, greater or equal to back pain) * MRI evidence of spinal pathology consistent with symptoms * Candidates for ESI and pharmacotherapy Exclusion Criteria: * Untreated coagulopathy * Previous spine surgery * No MRI or non-concordant MRI study * Leg pain \> 15 years duration * Epidural steroid injection with…
Interventions
- BehavioralBehavioral manipulation of ESI expectations
5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.
- OtherNo behavioral manipulation of ESI expectations
1-slide summary of ESI portrayed in a neutral light.
- OtherNo behavioral manipulation of pharmacotherapy expectations
1-slide summary of medications for neuropathic pain portrayed in a neutral light.
Locations (2)
- Northwestern UniversityChicago, Illinois
- Walter Reed National Military Medical CenterBethesda, Maryland