Procedural Framing and Epidural Steroid Injection Outcomes

NCT07498140 | Recruiting

• 1 other identifier: STU00225684
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lumbosacral Radiculopathy

Keywords

Back pain; Lumbar radiculopathy; Epidural steroid injection; Placebo effect; Sciatica; Positive framing

Outcome Measures

Primary Outcomes (1)

• Mean reduction in average leg pain

  Mean reduction in average leg pain on a 0-10 numerical rating pain scale over the past week. This is the study's primary endpoint. 0=no pain, 10= worst pain imaginable.

  4 weeks

Secondary Outcomes (25)

• Leg pain at rest

  Up to 15 minutes after the procedure

• Leg pain with activity

  Up to 15 minutes after the procedure

• Back pain at rest

  Up to 15 minutes after the procedure

• Back pain with activity

  Up to 15 minutes after the procedure

• Patient satisfaction

  Up to 15 minutes after the procedure

Other Outcomes (3)

• Adverse events

  10-15 minutes (for ESI)

• Adverse events

  4 weeks

• Adverse events

  12 weeks

Study Arms (3)

Positive framing- ESI

EXPERIMENTAL

Patients will review around 5 slides detailing ESI in a very positive light and references, with study personnel available to answer questions.

Behavioral: Behavioral manipulation of ESI expectations

Neutral framing- ESI

PLACEBO COMPARATOR

Patients will review 1 slide that portrays ESI in a neutral light.

Other: No behavioral manipulation of ESI expectations

Pharmacotherapy with gabapentin, nortriptyline and/or duloxetine

PLACEBO COMPARATOR

Patients will review 1 slide that portrays adjuvant medications for neuropathic pain in a neutral light.

Other: No behavioral manipulation of pharmacotherapy expectations

Interventions

Behavioral manipulation of ESI expectations BEHAVIORAL

5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.

Positive framing- ESI

No behavioral manipulation of ESI expectations OTHER

1-slide summary of ESI portrayed in a neutral light.

Neutral framing- ESI

No behavioral manipulation of pharmacotherapy expectations OTHER

1-slide summary of medications for neuropathic pain portrayed in a neutral light.

Pharmacotherapy with gabapentin, nortriptyline and/or duloxetine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Untreated coagulopathy
• Previous spine surgery
• No MRI or non-concordant MRI study
• Leg pain \> 15 years duration
• Epidural steroid injection within past 2 years
• Signs or symptoms of cauda equina syndrome
• Previous failed trials with gabapentin and pregabalin and tricyclic antidepressants and duloxetine
• Allergic reactions to contrast dye prohibiting injection (e.g., tranforaminal ESI), gabapentinoids, tricyclic antidepressants or duloxetine, and contraindications to all of the above medications
• Referrals from surgery for diagnostic injections for surgical evaluation
• Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
• Pregnancy
• Inability to understand basic English

Sponsors & Collaborators

• Northwestern University: lead
• Phramongkutklao College of Medicine and Hospital: collaborator
• Ramathibodi Hospital: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

ENROLLING BY INVITATION

Related Publications (5)

• Schmidt S, Loef M, Ostermann T, Walach H. Treatment effects in pharmacological clinical randomized controlled trials are mainly due to placebo. J Clin Epidemiol. 2025 Mar;179:111658. doi: 10.1016/j.jclinepi.2024.111658. Epub 2024 Dec 27.

  PMID: 39733973 BACKGROUND

• Kaptchuk TJ, Stason WB, Davis RB, Legedza AR, Schnyer RN, Kerr CE, Stone DA, Nam BH, Kirsch I, Goldman RH. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ. 2006 Feb 18;332(7538):391-7. doi: 10.1136/bmj.38726.603310.55. Epub 2006 Feb 1.

  PMID: 16452103 BACKGROUND

• Sebastian A, Wyld L, Morgan JL. Examining the variation in consent in general surgery. Ann R Coll Surg Engl. 2024 Feb;106(2):140-149. doi: 10.1308/rcsann.2023.0020. Epub 2023 May 23.

  PMID: 37218649 BACKGROUND

• Kern A, Kramm C, Witt CM, Barth J. The influence of personality traits on the placebo/nocebo response: A systematic review. J Psychosom Res. 2020 Jan;128:109866. doi: 10.1016/j.jpsychores.2019.109866. Epub 2019 Nov 7.

  PMID: 31760341 BACKGROUND

• Kang H, Miksche MS, Ellingsen DM. Association between personality traits and placebo effects: a preregistered systematic review and meta-analysis. Pain. 2023 Mar 1;164(3):494-508. doi: 10.1097/j.pain.0000000000002753. Epub 2022 Aug 10.

  PMID: 35947877 BACKGROUND

MeSH Terms

Conditions

Back Pain; Radiculopathy; Sciatica

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Sciatic Neuropathy; Mononeuropathies; Neuralgia

Study Officials

• Steven P Cohen, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven P Cohen, MD

CONTACT

312-695-2500; steven.cohen@northwestern.edu

Jordan Wood, BS

CONTACT

312-695-2500; Jordan.Wood1@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (2)