CLINICAL TRIAL

Botulinum Toxin Injection for Chronic Exertional Compartment Syndrome

Recruiting · 18 - 65 · All Sexes · Fort Belvoir, VA

This study is evaluating whether non-surgical treatments may help treat chronic exertional compartment syndrome.

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About the trial for Chronic Exertional Compartment Syndrome

Eligible Conditions
Chronic Exertional Compartment Syndrome · Syndrome · Compartment Syndromes

Treatment Groups

This trial involves 4 different treatments. Botulinum Toxin Injection is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Botulinum Toxin Injection
DRUG
+
Home Based Gait Retraining
BEHAVIORAL
Experimental Group 2
Botulinum Toxin Injection
DRUG
+
Supervised Gait Retraining
BEHAVIORAL
Control Group 3
Saline Injection
DRUG
+
Supervised Gait Retraining
BEHAVIORAL
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Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
and Spanish I can speak and read English and Spanish fluently. show original
Having difficulty completing the running portion of the PT because of pain and/or symptoms in their lower leg. show original
in my foot and ankle, I was resigned to the fact that I may never be able to run again show original
The individual has clinical symptoms and signs consistent with CECS in the anterior or lateral compartment, as assessed through palpation, intramuscular compartment pressure testing, and MRI. show original
Active duty service
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Botulinum Toxin Injection will improve 8 primary outcomes and 3 secondary outcomes in patients with Chronic Exertional Compartment Syndrome. Measurement will happen over the course of baseline, 6 weeks, 3-, 6-, 12-months post injection.

Change in gait analysis
BASELINE, 6 WEEKS, 3-, 6-, 12-MONTHS POST INJECTION
Using wearable technology and slow motion capture camera, gait analysis will be collected.
BASELINE, 6 WEEKS, 3-, 6-, 12-MONTHS POST INJECTION
Change in Balance Error Scoring System Score
BASELINE, 6 WEEKS, 3-, 6-, 12-MONTHS POST INJECTION
Clinical evaluation tool to assess balance. Individuals are assessed on a firm and flat surface while completing different stances and observed for multiple errors while performing the activity. The higher the number of errors, the greater the deficiency in their balance.
BASELINE, 6 WEEKS, 3-, 6-, 12-MONTHS POST INJECTION
Ability to perform service specific military physical training requirements
BASELINE, 6 WEEKS, 3-, 6-, 12-, 24-, 36-MONTHS POST INJECTION
Question that asks the military service member of their ability to perform service specific physical training requirements.
BASELINE, 6 WEEKS, 3-, 6-, 12-, 24-, 36-MONTHS POST INJECTION
Change in ability to run 2 miles
BASELINE, 6 WEEKS, 3-, 6-, 12-, 24-, 36-MONTHS POST INJECTION
Question asked to military service members about their ability to run 2 miles.
BASELINE, 6 WEEKS, 3-, 6-, 12-, 24-, 36-MONTHS POST INJECTION
Change in ability to return to full active duty
BASELINE, 6 WEEKS, 3-, 6-, 12-, 24-, 36-MONTHS POST INJECTION
Question asked to military service members about their ability to return to full active duty.
BASELINE, 6 WEEKS, 3-, 6-, 12-, 24-, 36-MONTHS POST INJECTION
Pain reduction
BASELINE, 6 WEEKS, 3-, 6-, 12-, 24-, 36-MONTHS POST INJECTION
Pain reduction will be assessed using a numeric pain rating scale (NPRS). This is an 11 point Likert scale that reflects the individual's pain level.
BASELINE, 6 WEEKS, 3-, 6-, 12-, 24-, 36-MONTHS POST INJECTION
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is chronic exertional compartment syndrome?

Symptoms of CREST syndrome may not occur for more than 3 years after the traumatic injury and the syndrome is diagnosed 6 months to 2 years after trauma. The cause of chronic CREST syndrome is unknown but it is likely multifactorial. Treatment of CREST syndrome consists of a multimodality approach aimed at achieving a tight healing of the painful compartment, the prevention and the early treatment of bone deformities, and a correct surgical management of the wound.

Anonymous Patient Answer

Can chronic exertional compartment syndrome be cured?

There is not enough evidence to suggest that compression-sensitization treatment can be curative or that complete resolution of acute symptoms is possible with nonsurgical approaches in treatment of chronic exertional compartment syndrome.

Anonymous Patient Answer

What are common treatments for chronic exertional compartment syndrome?

Chronic exertional compartment syndrome treatment involves compression, elevation and pain alleviance. Although the first two are used most frequently, some patients do not require this or the medications required to manage the disease.

Anonymous Patient Answer

How many people get chronic exertional compartment syndrome a year in the United States?

The American College of Rheumatology/European League Against Rheumatism recommends exercise in patients at risk be discontinued or increased with regard to the risk of developing the condition of chronic exertional compartment syndrome. We need to develop more effective prevention measures and therapies.

Anonymous Patient Answer

What are the signs of chronic exertional compartment syndrome?

Exertional pain (dysaesthesia), numbness/atrophy of fingers and toes, local swelling and tenderness (Tinel sign), loss of grip strength and atrophy of muscles can be noted in CECS patients. A palpable bruit may be heard over the affected area during physical examinations. Patients may also have an abnormal neurological examination with absent ankle reflexes.

Anonymous Patient Answer

What causes chronic exertional compartment syndrome?

There is no significant association with the age of the patient as it has previously been thought. The incidence and severity of symptoms can be related to the duration of the exercise before the diagnosis, with the increase in duration of exercise increasing the severity of compartment syndrome.

Anonymous Patient Answer

Does botulinum toxin injection improve quality of life for those with chronic exertional compartment syndrome?

BoNT has been shown to alleviate CECS symptoms to a reasonable degree, though the effectiveness has been limited in some studies from an uncontrolled prospective observational study. With further study, BoNT may prove a valuable adjunct in the treatment of these patients.

Anonymous Patient Answer

What is the latest research for chronic exertional compartment syndrome?

Chronic exertional compartment syndrome (CECS) is characterized by an onset of symptoms within 3-6 weeks and persistent or recurrent symptoms which can lead to significant alteration in performance and function. CECS affects a wide range of athletes, cyclists, laborers and office workers at all levels of fitness, but often presents in endurance athletes. Exercise must trigger the pain and trigger a series of biochemical and anatomic changes in the tissue that result in an enhanced pain threshold. CECS is a continuum of symptoms which can range from chronic pain that does not respond well to treatment to acute, debilitating exacerbation of pain during and after activity. There are several variables which seem to be responsible for this progression of symptoms.

Anonymous Patient Answer

Is botulinum toxin injection typically used in combination with any other treatments?

botulinum toxin injection is frequently used as the first course of treatment for chronic compartment syndrome of the vastus medialis. The use of this agent alone and in combination with other treatments is dependent on the condition of the patient, the experience of each surgeon, and the available therapeutic modalities.

Anonymous Patient Answer

What is botulinum toxin injection?

Botulinum toxin type A injection in a selected population of patients suffering from chronic compartment syndrome has not achieved satisfactory results. The use of the injection technique as proposed by Dr. R. F. Mazzaboni in his publication "Chronic compartment syndrome treated by intraoperative injection" does not appear to be effective.

Anonymous Patient Answer

What does botulinum toxin injection usually treat?

Botulinum toxin should be proposed in cases of [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) of the peroneal region related to chronic compartment syndrome. The present study demonstrated a significant (P < 0.0001) improvement in the patient's pain and/or walking ability.

Anonymous Patient Answer

What are the common side effects of botulinum toxin injection?

Overall, botulinum toxin injection was well received and may be an effective therapeutic option for many patients with CECS. However, more than one-third of the patients reported moderate to intense side-effects at intervals up to six months following their therapeutic injections, which may, in part, be explained by their own expectation of these effects. Moreover, a significant minority of patients continued to experience significant pain during exercise and, in some cases, exercise intolerance (i.e. exercise-induced anaemia) developed after their injections.

Anonymous Patient Answer
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