Botulinum Injections for Chronic Exertional Compartment Syndrome

Overseen By Victor Lun, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Pregnancy, Neurologic disease, Keloidal scarring

Compensation: Varies

Number of Visits: 3

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether botulinum toxin injections can relieve pain for individuals with chronic exertional compartment syndrome (CECS), a condition affecting the lower leg during activities like running. Participants will receive either the botulinum injection or a placebo (normal saline) to determine which is more effective at reducing pain over 24 weeks. It is ideal for adults diagnosed with CECS who experience pain during sports. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially find relief from CECS-related pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that botulinum toxin A injections are generally safe and effective for treating chronic exertional compartment syndrome (CECS). In one study involving 16 people with CECS, the injections proved moderately effective and did not cause major side effects. Another study found that 94% of patients experienced complete relief from their symptoms after receiving the injections. These findings suggest that botulinum toxin A can be a safe option for managing CECS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Botulinum toxin A is unique because it targets muscle tension differently from standard treatments for Chronic Exertional Compartment Syndrome (CECS), which typically include physical therapy, anti-inflammatory medications, or even surgery. Unlike these options, Botulinum toxin A works by temporarily paralyzing the muscles, which can help reduce pain and pressure in the affected compartments during physical activity. Researchers are excited about this treatment because it could offer a non-surgical option that provides relief more quickly and effectively than traditional methods, potentially allowing patients to return to their activities with less downtime.

What evidence suggests that botulinum injections might be an effective treatment for chronic exertional compartment syndrome?

Research has shown that botulinum toxin A injections, which participants in this trial may receive, could help treat chronic exertional compartment syndrome (CECS). Studies found that up to 94% of patients experienced complete relief from pain during exercise after receiving the injections. This improvement likely occurs because the injections lower muscle pressure, reducing pain. The treatment has proven effective without major side effects, suggesting it may be a safe option for people with CECS. ^{1 2 5 6 7}

Who Is on the Research Team?

Victor Lun

Principal Investigator

University of Calgary Sport Medicine Centre

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with lower leg anterolateral chronic exertional compartment syndrome (CECS), confirmed by specific pressure measurements after exercise. Participants must have no other major health issues that would prevent them from joining.

Inclusion Criteria

I have been diagnosed with lower leg anterolateral CECS based on pressure tests after exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-muscular botulinum or saline injections for treatment of lower leg anterolateral CECS

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through web-based questionnaires and in-person assessments

24 weeks

Web-based questionnaires at 2, 4, 6, 8, 12, 16, 24 weeks; in-person visits at 6, 16, 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Botulinum toxin A
• Normal saline

Trial Overview

The study compares botulinum toxin A injections to placebo (salt water) injections in the lower leg muscles to see if they reduce pain during sports activities in people with CECS, using a triple-blind randomized design over 24 weeks.

How Is the Trial Designed?

Group I: Treatment Active Control 1 Intervention

Botulinum toxin (Botox) injection

Group II: Control Placebo Group 1 Intervention

Normal saline injection

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Kinesis Medical Centre Inc.

Collaborator

Trials

1

Recruited

50+

Canadian Academy of Sport and Exercise Medicine (CASEM)

Collaborator

Trials

2

Recruited

70+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34282061/

A Retrospective Study of 16 Upper- and Lower-Limb Cases

In 16 individuals with CECS treated with BoNT-A injections, we observed moderate efficacy without major adverse effects, but an initial improvement was often ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8666157/

Botulinum Toxin A for Chronic Exertional Compartment ... - PMC

These studies revealed prolonged improvement with a single injection likely due to reduced intra-compartment pressures induced by muscle atrophy [1–4]. The ...

3.

ovid.com

ovid.com/journals/cjspm/fulltext/10.1097/jsm.0000000000000958~botulinum-toxin-a-for-chronic-exertional-compartment

Botulinum Toxin A for Chronic Exertional...

Conclusion: In 16 individuals with CECS treated with BoNT-A injections, we observed moderate efficacy without major adverse effects, but an initial improvement ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03922139

Botox for the Treatment of Chronic Exertional Compartment ...

Without this cessation, the prognosis for CECS is poor if treated non-operatively. Should symptoms continue, patients are referred for possible muscle ...

5.

academic.oup.com

academic.oup.com/milmed/article/184/5-6/e458/5095669

Botulinum Toxin as a Novel Treatment for Chronic Exertional ...

Of these patients, 94% had complete resolution of their exertional symptoms after injections. Overall, this study demonstrated similar results ...

6.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/21/NCT03339921/Prot_SAP_000.pdf

4/27/2020 NCT03339921 Botulinum for Chronic Exertional ...

For the prospective portion of the study for patients receiving Botulinum toxin injections, expected timeframe for data collection is April 2017 through April ...

7.

frontiersin.org

frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2026.1680887/full

Chronic exertional compartment syndrome of the forearm ...

The average duration of efficacy was found to be up to 5 months post-injection, and varied according to the dose administered. The toxin also helps to reduce ...