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Botox may help runners avoid surgery for leg pain

NCT ID NCT05466539

Symptom relief Sponsor: Emory University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study tested whether Botox injections could treat chronic leg pain in runners, a condition called chronic exertional compartment syndrome (CECS). Only 3 people took part, and they received Botox in specific leg muscles. The goal was to see if this could replace surgery, which is the current standard treatment. Because the study was very small, the results are not conclusive.

What this could mean

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

Active substance
abobotulinumtoxinA (Botox)
What this could lead to
If it works, this could offer a non-surgical treatment for chronic leg pain in runners, reducing recovery time.
What could go wrong
This was a very small, early-phase trial with only 3 participants, so results may not apply to everyone. The treatment is not yet proven effective.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

3 people

The number who actually took part.

Started

Apr 2024

Finished

Aug 2025

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Baseline Comparator Group: Inclusion Criteria: * Adult male and female runners aged 18-65 years * Group providing normative values for SWE and needle manometry - ICP assessments Exclusion Criteria: * History of Neuromuscular disease, serious soft-tissue injury, fractures, and surgery to the lower limb(s). Treatment Groups: Inclusion Criteria: * Confirmatory pressure values at diagnosis: Pre-exercise \> 15 mmHg; 1-min. post \> 30mmHg; or 5-min. post \> 20mmHg * Ages 18-65 years inclusive at study onset. * Ability to adhere to protocol. * Botulinum toxin naïve (lower extremity). Others previously treated, \> than 6 mos. before study entry. Exclusion Criteria: * Diagnosis of comorbid pain conditions, including claudication and/or popliteal artery entrapment syndrome. * Serious soft tissue injury, fractures, or surgery in the lower limb(s) \< than 12 months before study entry. * Current need for surgery at any level of the lower extremity. * Treatment with any drug known to interfere with neuromuscular function (e.g., aminoglycoside antibiotics or neuromuscular blocking agents). * Any other medical condition, laboratory, or diagnostic procedure finding that might preclude the administration of aboBoNTA (Dysport®). * Ongoing infection at the injection sites. * Diagnosed as either resistant or sensitive to botulinum toxin treatment of any type or to any components of Dysport® * Cow milk protein allergy. * Vulnerable patient populations such as adults unable to consent, pregnant women, prisoners, persons who have not obtained the legal age for consent to treatment or procedures

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Conditions

The condition(s) this trial relates to.

compartment syndrome

As listed by the trial registrant

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

Compartment syndrome of leg

Contacts and locations

Locations

  • Emory Hawks Sports Medicine Center

    Brookhaven, Georgia, 30329, United States

  • Emory Sports Medicine-Dunwoody

    Atlanta, Georgia, 30338, United States

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