Botox for Compartment Syndrome

Overseen By Gemma Gliori

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Wisconsin, Madison

Must not be taking: Aminoglycosides, Muscle relaxants, Blood thinners

Disqualifiers: Neuromuscular, Pulmonary, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Botox can relieve pain for people with Recurrent Chronic Exertional Compartment Syndrome (R-CECS), a condition causing muscle pain during physical activity. Participants will receive Botox injections in the affected lower leg muscles to determine if it reduces their pain. The study seeks individuals already diagnosed with R-CECS who have undergone surgery to release muscle pressure. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications, especially those that affect neuromuscular function, muscle relaxants, botulinum neurotoxin agents, and blood-thinning medications like Plavix, Coumadin, Eliquis, and Xarelto.

What is the safety track record for Botox?

Research has shown that Botox injections for treating Chronic Exertional Compartment Syndrome (CECS) are generally safe. In one study involving 16 individuals with this condition, Botox proved moderately effective and did not cause any major side effects. Participants reported no serious negative effects, indicating that the treatment is well-tolerated.

Another study found that Botox significantly reduced muscle pressure in 87.5% of patients for up to nine months after the injection. Some minor side effects, such as bruising, pain, or redness at the injection site, might occur, but these are not considered serious. Overall, Botox appears to be a safe option for individuals with this condition. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Botox is unique because it offers a new approach to treating Recurrent Chronic Exertional Compartment Syndrome (R-CECS) by using botulinum toxin to target muscle tightness directly. Traditional treatments like physical therapy and surgery focus on relieving pressure or improving biomechanics, but Botox works by relaxing the muscles, potentially reducing symptoms more efficiently. Researchers are excited because this method could lead to faster relief and might be less invasive compared to surgical options. Plus, Botox's use in this context could provide a novel, non-surgical option for patients who haven't found relief through other treatments.

What evidence suggests that Botox might be an effective treatment for R-CECS?

Research has shown that Botox injections can reduce pain in individuals with conditions like Recurrent Chronic Exertional Compartment Syndrome (R-CECS). One study with 16 participants who had Chronic Exertional Compartment Syndrome (CECS) found Botox injections moderately effective, with no major side effects reported. Some participants experienced initial pain relief, though the level of benefit varied. Botox likely works by relaxing muscles, which may reduce pressure and pain in the leg compartments. In this trial, participants with R-CECS will receive Botox injections as a less risky and potentially cheaper alternative to surgery for managing these symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Suer, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing to provide written informed consent

You are willing to comply with all study procedures and be available for the duration of the study.

Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria

You have taken medication that affects your muscles or blood clotting in the past, or are currently taking blood-thinning medication.

The investigator has decided that you are not suitable to participate in the study for other reasons.

You have a lung condition such as asthma, pneumonia, or a respiratory infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Clinic Visit

Baseline measurements and Botox injection are administered

1 day

1 visit (in-person)

Treatment Follow-up

Follow-up visit to assess ankle strength and monitor side effects

2 months

1 visit (in-person)

Extended Follow-up

Telephone follow-up assessments of UWRI at 4 and 6 months

4 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Botox

How Is the Trial Designed?

Group I: Participants with R-CECS Experimental Treatment 1 Intervention

Botox to be injected under standard palpatory technique into the affected lower leg compartment.

Botox is already approved in United States, European Union for the following indications:

Approved in United States as Botox for:

• Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
• Urinary incontinence due to detrusor overactivity associated with a neurologic condition

Approved in European Union as Botox for:

• Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05006417

Botox for the Treatment of Recurrent Chronic Exertional ... 10 participants with Recurrent Chronic Exertional Compartment Syndrome (R-CECS) will be enrolled in a 6 month study at the University of Wisconsin Hospitals ...

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03922139?tab=results

Study Results | Botox for the Treatment of Chronic ... A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different ...

4. trialstoday.org trialstoday.org/trial/NCT05466539

Chronic Exertional Compartment Syndrome (CECS) ... The investigators propose a single-site randomized clinical trial to investigate the use of abobotulinumtoxinA in the treatment of CECS. Researchers also look ...

5. ctv.veeva.com ctv.veeva.com/study/botulinum-for-chronic-exertional-compartment-syndrome

Botulinum for Chronic Exertional Compartment Syndrome We think botulinum toxin injections will be a potentially cost-effective, low-risk alternative to surgery in reducing pain and returning ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03922139

Botox for the Treatment of Chronic Exertional Compartment ... After diagnosis of Chronic Exertional Compartment Syndrome (CECS), the participants will be referred to both physical therapy and Botox injection.

7. mirrorusuhs.org mirrorusuhs.org/mirror-projects/project5

Registry Development and Non-Surgical Treatment ... One case series studying botulinum toxin injections for CECS demonstrated normalized intramuscular pressure up to nine months post-injection in 87.5% (14/16) of ...

8. cureus.com cureus.com/articles/196154-chronic-exertional-compartment-syndrome-in-athletes-an-overview-of-the-current-literature

Chronic Exertional Compartment Syndrome in Athletes Ding et al. described the fasciotomy as a safe procedure with a 48%-94% satisfaction rate. Comparison of the outcomes of endoscopic release and ...