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Botulinum toxin type A versus sodium chloride for patients with chronic exertional compartment syndrome of the leg

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Chronic exertional compartment syndrome is a condition where the muscles in the front of the lower leg become tight and painful during exercise because the pressure inside the muscle compartment rises. The study will test whether injecting a small amount of Botulinum toxin type A directly into those muscles, using an intramuscular route, can reduce the pain and improve walking ability compared with a sodium chloride injection that serves as a placebo.

The purpose of the study is to see if the toxin injections can lessen symptoms and lower the need for surgery in people whose condition has not improved with usual care. Participants will receive a single set of injections, then return for regular check‑ins where they will answer simple questions about how they feel and how well they can move. The study will follow each person for several months to monitor changes in pain, function, and whether any surgical procedures are avoided.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Consent

    You will be asked to read and sign a consent form that explains the purpose of the study and what is required of you.

    Your participation is voluntary, and you may withdraw at any time.

  2. Step 2

    Baseline Assessment

    You will complete questionnaires about your leg symptoms and overall function.

    A health professional will record your medical history and perform a physical examination of the lower leg.

  3. Step 3

    Randomization

    After the baseline assessment, you will be randomly assigned to receive either botulinum toxin A or a sodium chloride placebo.

    The assignment is double‑blind, meaning neither you nor the treating staff will know which product you receive.

  4. Step 4

    Injection Administration

    You will receive a single intramuscular injection into the anterior compartment of the leg.

    If you are assigned to the active group, the injection contains botulinum toxin A at a dose of 100 IU (international units).

    If you are assigned to the placebo group, the injection contains sodium chloride solution at a volume of 5000 ml.

  5. Step 5

    Immediate Post‑Injection Monitoring

    You will be observed for a short period after the injection to ensure there are no immediate reactions.

    Staff will check the injection site and ask about any discomfort.

  6. Step 6

    Follow‑Up Assessments

    You will return for scheduled visits where you will complete the Single Assessment Numeric Evaluation (SANE) score, a simple questionnaire that measures your perceived leg function.

    At each visit, the study team will ask about any side effects, record any additional treatments you may have received, and perform a brief physical check of the leg.

  7. Step 7

    Final Evaluation

    At the end of the study period, you will complete a final set of questionnaires and undergo a concluding physical examination.

    The results will be used to compare the effect of botulinum toxin A with the sodium chloride placebo on the need for surgical intervention and overall leg function.

Who can join the trial?

6 criteria

  • You are 16 years old or older.
  • You have been diagnosed with anterior compartment chronic exertional compartment syndrome (ant‑CECS) of the leg, based on your symptoms, a physical exam, and special tests.
  • Your leg problems have lasted at least four months without getting better.
  • You have tried the recommended non‑surgical care (such as gait‑retraining physical therapy) and it did not relieve your symptoms.
  • You have had a minimally invasive test that measures pressure inside the leg muscle compartment (intracompartmental pressure (ICP) measurement) and at least one reading was higher than the limit set by the Pedowitz criteria.
  • You can be either male or female.

Who cannot join the trial?

9 criteria

  • Being older than 50 years.
  • Having chronic exertional compartment syndrome (pain and pressure in the leg) in any part of the leg other than the front (anterior) compartment.
  • Having other leg problems that could affect treatment, such as shin splints (pain along the shin bone), compression of the common peroneal nerve (a nerve that runs along the outer leg), or compression of the popliteal artery (a blood vessel behind the knee).
  • Having a known allergy to botulinum toxin type A (the medicine being tested).
  • Having a leg injury that required medical treatment in the past six months.
  • Having had a previous surgical cut of the leg fascia, known as a fasciotomy.
  • Having certain muscle diseases such as myasthenia gravis, amyotrophic lateral sclerosis (ALS), or Eaton‑Lambert syndrome.
  • Having other health conditions that could affect leg pain, such as diabetes (with or without nerve damage), poor vein function (venous insufficiency), or reduced blood flow in the arteries (peripheral arterial disease).
  • Having an infection on the leg where the injection would be given.
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Investigated drugs

Botulinum toxin type A is a medication that temporarily weakens muscles. In this study it is injected into the front muscles of the lower leg to see if it can reduce pain and improve walking for people with chronic exertional compartment syndrome who have not helped from other treatments. The injection works by blocking signals from nerves to the muscle, which can lower pressure inside the muscle compartment during activity. Researchers compare its effects with a harmless saline injection to find out if it provides real benefit.

What is already known about the treatment

  • Sodium Chloride 0.9%, Solution for Injection

    This sterile saline is given by intramuscular injection in a volume of 5000 ml as a placebo. It is a widely used electrolyte solution that helps maintain fluid and salt balance in the body and is listed in medical literature as a standard supportive fluid. The main indication is fluid replacement and as a control in clinical studies, with no direct therapeutic effect on the condition being studied. It works by providing sodium and chloride ions that replace lost fluids, and it is classified as an electrolyte solution (ATC B05XA03).

  • Botulinum Toxin Type A

    The test drug is injected intramuscularly in a dose of 100 IU to target leg muscles. It is an approved neurotoxin that is used to treat muscle over‑activity conditions and is well documented in medical research. Its primary purpose in this trial is to reduce muscle contraction that contributes to chronic exertional compartment syndrome. The toxin blocks the release of the signaling chemical acetylcholine at nerve endings, preventing muscle tightening, and it belongs to the class of neuromuscular blocking agents (botulinum toxin).

Investigated diseases

Chronic exertional compartment syndrome of the leg - Chronic exertional compartment syndrome of the leg is a condition where pressure builds up inside a muscle compartment during activity, causing pain and tightness. The increased pressure reduces blood flow and nerve function, leading to swelling and discomfort that worsens with continued exertion. Symptoms usually improve with rest, but repeated episodes can lead to increasing limitation of activity.
Trial detailsLast updated 17 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524042-99-00Protocol code2025-524042Estimated enrolment108 patientsSponsorUniversitair Medisch Centrum Utrecht

sourced from the EU Clinical Trials Register and site verification

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