Botulinum for Chronic Exertional Compartment Syndrome

The study will be a prospective cohort pilot study designed to compare Active Duty patients,
18 years of age or older, with Chronic Exertional Compartment Syndrome (CECS) undergoing two
different treatment interventions. The first arm will be patients receiving investigational
botulinum toxin injections. The second arm will be patients who undergo the standard of care
surgical fasciotomy. Both arms will be evaluated for pain relief with the universal pain
scale and lower extremity functional index (LEFI) surveys at pre-treatment and again at one,
three, and six months post-treatment. Clinical data that will be analyzed for research
purposes in both groups include age, sex, height, weight, body mass index, time to diagnosis,
minutes of exercise prior to onset of symptoms, minutes of rest before relief of symptoms,
LEFI and pain on the Universal Pain Assessment Tool.

Inclusion Criteria:

- Adult ages 18-65

- Active duty military

- Unable to run 1.5 miles without producing symptoms, including aching, burning,
numbness, tingling, or weakness in the affected limb

- Failed conservative treatment over a period of 2 months, including trial of rest,
NSAIDs, icing, and stretching routine

- Meets standard of care clinical diagnostic intramuscular compartment pressure criteria
for CECS, based on standardized IMP needle testing. See below for testing protocol and
criteria.

Exclusion Criteria:

- Prior Botulinum toxin injections into the affected limb

- Prior compartment release of the affected limb

- Pregnant or becomes pregnant during the study

- Standard of care clinical exams indicating other more likely causes of leg pain