Chronic Exertional Compartment SyndromeNCT05765071
Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.
A study testing Botulinum toxin A and Normal saline in people with Chronic Exertional Compartment Syndrome, run by University of Calgary at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Exertional Compartment Syndrome
- What is being tested?
- Botulinum toxin A and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jul 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Female patients who are pregnant, trying to get pregnant or lactating
- History of keloidal scarring
- History of any significant neurologic disease (ie: amyotrophic lateral sclerosis, motor neuropathy, myasthenia gravis, Lambert-Eaton syndrome)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary Sport Medicine Centre
Calgary, Alberta, T2N 1N4
CECS-Botox Study Coordinator, 403-220-8944, cecs.study@ucalgary.ca
Victor Lun, MSc, MD
About this study
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?
Read more
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.
Read the detailed description
Chronic exertional compartment syndrome (CECS) of the lower leg muscle compartments is a common problem in the active population. The condition often significantly restricts patients from participating in their desired activity to the best of their ability. The pathology of CECS is related to increased intra-muscular pressure related to a restrictive fascia (envelope around the muscle or muscle group). The current standard of care for definitive treatment of CECS is a surgical fasciotomy. However, there have been a number of case reports reporting successful reduction of the symptoms of CECS with intra-muscular botulinum injections. Intra-muscular botulinum injections may reduce the symptoms of CECS by potentially decreasing muscle activation, therefore diminishing blood flow, which may reduce intra-compartmental muscle expansion and pressure of the compartment during exercise. Thus botulinum injections might provide a non-operative method of treating CECS.
This study will determine the effectiveness of intra-muscular botulinum injection, compared to a normal saline placebo, for treatment of lower leg anterolateral CECS, over a 24-week period. Participants will answer a web-based questionnaire before receiving the injection (Baseline) and at regular follow-up intervals at 2, 4, 6, 8, 12, 16, 24-weeks post-injection. The questionnaires will ask the participant to provide detailed information about their painful sport activity, and the maximum level of pain that they experience during that activity. They will also characterize the type of pain experienced, record the time to initial onset and duration of pain during the painful sport activity, and provide an overall measure of their leg function using a Single Assessment Numeric Evaluation (SANE) score. Participants will also attend an in-person appointment in clinic at Baseline, and at 6, 16 and 24-weeks post-injection for assessment of numbness and/or tingling in the foot, ankle instability, and manual ankle muscle power.
- Conditions
- Chronic Exertional Compartment Syndrome
- Being tested
- Botulinum toxin A, Normal saline
- Keywords
- anterolateral, CECS, lower leg
- Medical subject headings
- Chronic Exertional Compartment Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ABiological
Also called Botox
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.
Normal salineBiological
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Botulinum toxin (Botox) injection Receives: Biological: Botulinum toxin A |
| Control | Placebo comparator | Normal saline injection Receives: Biological: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum level of pain at time of painful sport activity from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Pain measured on a visual analog scale from 0 to 100, where 0 represents no pain and 100 represents pain as bad as it can be
Measured: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Secondary outcomes (8)
Change in time to onset of pain during sport activity (minutes)
Comparison of time to onset of pain during sport activity (minutes) at Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Measured: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in duration of exercise before having to stop due to pain (minutes)
Comparison of duration of exercise before having to stop due to pain (minutes) at Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Measured: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in duration of pain after stopping painful exercises (minutes)
Comparison of duration of pain after stopping painful exercises (minutes) at Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Measured: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in the numbness and/or tingling in foot during painful exercises from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Presence or absence of numbness and/or tingling in foot during painful exercises
Measured: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in ankle dorsiflexion muscle power from Baseline to 6, 16 and 24-weeks post-injection
Manual ankle dorsiflexion muscle power test, graded on the following scale:
0 No muscle activation
- Flicker of contraction, but no movement of the ankle joint
- Dorsiflexion of the foot with the effect of gravity eliminated
- Dorsiflexion of the foot against gravity but no added resistance
- Dorsiflexion of the foot against gravity and moderate resistance
- Dorsiflexion of the foot against gravity and full resistance
Measured: Baseline, and 6, 16 and 24-weeks post-injection
Ankle eversion muscle power
Manual ankle eversion muscle power test, graded on the following scale:
0 No muscle activation
- Flicker of contraction, but no movement of the ankle joint
- Eversion of the foot with the effect of gravity eliminated
- Eversion of the foot against gravity but no added resistance
- Eversion of the foot against gravity and moderate resistance
- Eversion of the foot against gravity and full resistance
Measured: Baseline, and 6, 16 and 24-weeks post-injection
Change in Single Assessment Numeric Evaluation (SANE) from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Comparison from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection for self-assessed rating of overall leg function using a Visual Analog Scale response, where 0 is severely abnormal and 100 is completely normal.
Measured: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in ankle instability from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in patient-reported assessment of presence or absence of ankle instability from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Measured: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start17 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Exertional Compartment SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants receiving botulinum toxin will be compared to those receiving normal saline.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Academy of Sport and Exercise Medicine (CASEM), Kinesis Medical Centre Inc.
- Responsible party
- Sponsor
- Investigators
- Victor Lun, Principal investigator, University of Calgary Sport Medicine Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765071
- Sponsor's protocol ID
- REB22-0439
- Status last verified
- May 2026
- First submitted
- 15 Feb 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests for individual participant data will be considered upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.
- ClinicalTrials.gov ID
- NCT05765071
- Acronym / sponsor ID
- REB22-0439
- Conditions
- Chronic Exertional Compartment Syndrome
- Keywords
- anterolateral, CECS, lower leg
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Academy of Sport and Exercise Medicine (CASEM), Kinesis Medical Centre Inc.
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic exertional compartment syndrome (CECS) of the lower leg muscle compartments is a common problem in the active population. The condition often significantly restricts patients from participating in their desired activity to the best of their ability. The pathology of CECS is related to increased intra-muscular pressure related to a restrictive fascia (envelope around the muscle or muscle group). The current standard of care for definitive treatment of CECS is a surgical fasciotomy. However, there have been a number of case reports reporting successful reduction of the symptoms of CECS with intra-muscular botulinum injections. Intra-muscular botulinum injections may reduce the symptoms of CECS by potentially decreasing muscle activation, therefore diminishing blood flow, which may reduce intra-compartmental muscle expansion and pressure of the compartment during exercise. Thus botulinum injections might provide a non-operative method of treating CECS.
This study will determine the effectiveness of intra-muscular botulinum injection, compared to a normal saline placebo, for treatment of lower leg anterolateral CECS, over a 24-week period. Participants will answer a web-based questionnaire before receiving the injection (Baseline) and at regular follow-up intervals at 2, 4, 6, 8, 12, 16, 24-weeks post-injection. The questionnaires will ask the participant to provide detailed information about their painful sport activity, and the maximum level of pain that they experience during that activity. They will also characterize the type of pain experienced, record the time to initial onset and duration of pain during the painful sport activity, and provide an overall measure of their leg function using a Single Assessment Numeric Evaluation (SANE) score. Participants will also attend an in-person appointment in clinic at Baseline, and at 6, 16 and 24-weeks post-injection for assessment of numbness and/or tingling in the foot, ankle instability, and manual ankle muscle power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants receiving botulinum toxin will be compared to those receiving normal saline.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Biological: Botulinum toxin ABotulinum toxin (Botox) injection |
| Control | Placebo comparator | Biological: Normal salineNormal saline injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Female patients who are pregnant, trying to get pregnant or lactating
- History of keloidal scarring
- History of any significant neurologic disease (ie: amyotrophic lateral sclerosis, motor neuropathy, myasthenia gravis, Lambert-Eaton syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin AAlso: BotoxBotulinum 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 | Treatment |
| Normal salineAlso: PlaceboA 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. | Biological | Control |
Primary outcome
Change in maximum level of pain at time of painful sport activity from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Time frame: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Pain measured on a visual analog scale from 0 to 100, where 0 represents no pain and 100 represents pain as bad as it can be
8 secondary outcomes
Change in time to onset of pain during sport activity (minutes)
Time frame: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in duration of exercise before having to stop due to pain (minutes)
Time frame: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in duration of pain after stopping painful exercises (minutes)
Time frame: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in the numbness and/or tingling in foot during painful exercises from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Time frame: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in ankle dorsiflexion muscle power from Baseline to 6, 16 and 24-weeks post-injection
Time frame: Baseline, and 6, 16 and 24-weeks post-injection
Ankle eversion muscle power
Time frame: Baseline, and 6, 16 and 24-weeks post-injection
Change in Single Assessment Numeric Evaluation (SANE) from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Time frame: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Change in ankle instability from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Time frame: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Requests for individual participant data will be considered upon request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor Lun principal investigator
University of Calgary Sport Medicine Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin A and Normal saline in people with Chronic Exertional Compartment Syndrome, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Lun, MD (403-220-8518, vmylun@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum level of pain at time of painful sport activity from Baseline to 2, 4, 6, 8, 12, 16 and 24-weeks post-injection (time frame: Baseline, and 2, 4, 6, 8, 12, 16 and 24-weeks post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.