Testing Botulinum toxin A against a placebo for chronic exertional compartment syndrome
Official title: Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.
- 2 groups
- One site, in Calgary
- Recruiting
Interventions
- Biological therapy
Botulinum toxin A
Botulinum injections will be prepared by diluting 100 units of botulinum toxin A with 5.0mL of saline (20.0U/mL). A total of 100 units (5.0mL) of botulinum toxin A will be injected into the tibialis anterior, peroneus longus and peroneus brevis muscles of the affected leg. Under ultrasound guidance, the injectant will be deposited at two sites in each muscle near the motor points.
- Biological therapy
Normal saline
A total of 5.0mL of normal saline will be injected into the tibialis anterior, peroneus longus and peroneus brevis muscles of the affected leg. Under ultrasound guidance, the injectant will be deposited at two sites in each muscle near the motor points.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Calgary Sport Medicine Centre
Calgary, Alberta
Eligibility Criteria
See who this study is looking for4 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Confirmed diagnosis of lower leg anterolateral chronic exertional compartment syndrome (CECS), as measured post-exertional compartment pressure measurements of greater than 30 mmHg for immediate post-exertional compartment pressure, and greater than 12 mmHg at 5 minutes after stopping exercise.
Exclusion
- −History of keloidal scarring
- −History of any significant neurologic disease (ie: amyotrophic lateral sclerosis, motor neuropathy, myasthenia gravis, Lambert-Eaton syndrome)
- −Female patients who are pregnant, trying to get pregnant or lactating
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Botulinum toxin A.
Registry label: A: Treatment
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Normal saline.
Registry label: B: Control
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 50 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in maximum level of pain at time of painful sport activity from BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection — measured over Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05765071 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Botulinum toxin ABiological
Botulinum injections will be prepared by diluting 100 units of botulinum toxin A with 5.0mL of saline (20.0U/mL). A total of 100 units (5.0mL) of botulinum toxin A will be injected into the tibialis anterior, peroneus longus and peroneus brevis muscles of the affected leg. Under ultrasound guidance, the injectant will be deposited at two sites in each muscle near the motor points.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Normal salineBiological
A total of 5.0mL of normal saline will be injected into the tibialis anterior, peroneus longus and peroneus brevis muscles of the affected leg. Under ultrasound guidance, the injectant will be deposited at two sites in each muscle near the motor points.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 50 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 50 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection.
The study as a whole is currently expected to finish around 2028-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Calgary, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this pilot triple-blind randomized clinical trial is to determine the effectiveness of intra-muscular botulism injection for treatment of lower leg anterolateral chronic exertional compartment syndrome (CECS). Primary Research Question: What is the effectiveness of intra-muscular botulinum injection, compared to normal saline placebo, for reducing pain related to painful sport activity in patients with lower leg anterolateral chronic exertional compartment syndrome (CECS), over a 24-week period? Secondary outcomes will measure the time to initial onset and duration of pain during the painful sport activity, characterize the type of pain, foot paraesthesias, self-reported ankle instability, and ankle dorsiflexion and eversion muscle power. The Single Assessment Numeric Evaluation (SANE) score will provide a measure of overall leg function. Adult patients with a confirmed diagnosis of anterolateral CECS, as determined by post-exertional compartment pressure measurements, will be invited to participate in the study. Using concealed, consecutively-numbered randomization envelopes, participants will be randomly assigned to receive either the botulinum (treatment) or the normal saline (control) injection. Participants will answer a web-based outcome questionnaire at Baseline (prior to receiving the injection) and at 2, 4, 6, 8, 12, 16, 24-weeks follow-up. Participants will be asked to do their painful sport activity the day before completing the questionnaire. Ankle dorsiflexion and eversion muscle power will be manually measured by a physiatrist in clinic at 6, 16 and 24-week follow-up visits.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.