Procedural Framing and Epidural Steroid Injection Outcomes

ConditionLumbosacral Radiculopathy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 & worst leg pain is >/=4)

Disqualifiers

Untreated coagulopathy

Previous spine surgery

No MRI or non-concordant MRI study

Leg pain > 15 years duration

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

210 Participants

are divided into 3 treatment groups

Group A: Positive framing- ESIExperimental treatment 1 intervention

Group B: Neutral framing- ESIPlacebo comparator 1 intervention

Group C: Pharmacotherapy with gabapentin, nortriptyline and/or duloxetinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

4 weeks

Secondary outcomes

Leg pain at rest

Leg pain at rest on a 0-10 verbal rating scale while in the recovery area. 0=no pain, 10= worst pain imaginable.

Time frame

Up to 15 minutes after the procedure

Leg pain with activity

Leg pain with walking and bending on a 0-10 verbal rating scale while in the recovery area

Time frame

Up to 15 minutes after the procedure

Back pain at rest

Back pain at rest on a 0-10 verbal rating scale while in the recovery area

Time frame

Up to 15 minutes after the procedure

Back pain with activity

Back pain with activity (walking, bending) on a 0-10 verbal rating scale while in the recovery area

Time frame

Up to 15 minutes after the procedure

Other outcomes

Adverse events

Any adverse event or complication

Time frame

10-15 minutes (for ESI)

Adverse events

Any adverse event, attributed to treatments or not

Time frame

4 weeks

Adverse events

Any adverse event, attributed to treatments or not, at all time points

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Collaborator

Ramathibodi Hospital

Collaborator

Walter Reed National Military Medical Center

Collaborator

First Lviv Medical Union

Collaborator

Source ClinicalTrials.gov

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