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Mind over matter: positive framing may boost pain shot results

NCT ID NCT07498140

Symptom relief Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests whether describing a common pain shot (epidural steroid injection) in a very positive way helps reduce leg pain more than a neutral description. Researchers will compare three groups: positive framing of the shot, neutral framing of the shot, and neutral framing of pain medications. The goal is to see if a patient's expectations can improve real-world pain relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention (positive or neutral framing of epidural steroid injections)
What this could lead to
If it works, this could show that simply describing a treatment in a positive way improves pain relief, without changing the actual procedure.
What could go wrong
This is an early-stage behavioral study, not a drug trial. The effect may be small or not last long, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \& worst leg pain is \>/=4) * 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 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

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Conditions

The condition(s) this trial relates to.

Back Pain radiculopathy sciatica

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lumbosacral radiculopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • First Lviv Medical Union

    NOT_YET_RECRUITING

    Lviv, Ukraine

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Phramongkutklao Military Hospital

    RECRUITING

    Bangkok, Thailand

  • Walter Reed National Military Medical Center

    ENROLLING_BY_INVITATION

    Bethesda, Maryland, 20814, United States

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