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Can gait retraining or botox shots replace surgery for leg pain?

NCT ID NCT04409600

Symptom relief Sponsor: Walter Reed National Military Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested four non-surgical treatments for chronic exertional compartment syndrome (CECS), a condition that causes leg pain during exercise. 35 active-duty military members were assigned to supervised gait retraining, home-based gait retraining, saline injections, or botulinum toxin injections. Researchers tracked their running ability, pain, and function for up to two years to see if these options could offer an alternative to surgery.

What this could mean

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

Active substance
botulinum toxin injection
What this could lead to
If successful, this could provide effective non-surgical alternatives to surgery for people with chronic exertional compartment syndrome, helping them return to running and active duty without an operation.
What could go wrong
This is a small, early-phase study with only 35 participants, so results may not apply to everyone. The treatments may not work as well as surgery, and botulinum toxin injections carry risks like muscle weakness or allergic reaction.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Started

Nov 2020

Finished

Dec 2024

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 to 50 years

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: * Active duty service * Fluent in speaking and reading English * Unable to run 2 miles without producing pain and/or symptoms * Difficulty completing the running portion of their service-specific physical training due to pain and/or symptoms in their lower leg * Meets clinical diagnostic criteria for CECS of the anterior or lateral compartment per clinical examination (palpation, intramuscular compartment pressure, lower leg MRI). Exclusion Criteria: * Prior botulinum injection in the lower leg compartment of the affected limb * Prior compartment release of affected lower leg * Recent (within the last 6 months) lower limb injury that needed medical intervention * Completed formal gait retraining within the last 6 months * Allergic to botulinum toxin * Pregnant or breastfeeding * Medical examination that indicates a condition other than CECS

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Conditions

The condition(s) this trial relates to.

Chronic Exertional Compartment Syndrome compartment syndrome

As listed by the trial registrant

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

Chronic exertional compartment syndrome

Contacts and locations

Locations

  • Carl R. Darnell Army Medical Center

    Killeen, Texas, 76544, United States

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia, 22060, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20307, United States

  • Womack Army Medical Center

    Fort Bragg, North Carolina, 28310, United States

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