NCT05006417

Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

10 participants with Recurrent Chronic Exertional Compartment Syndrome (R-CECS) will be enrolled in a 6 month study at the University of Wisconsin Hospitals and Clinics to test the hypothesis that injection of Botox into the affected muscle group will alleviate pain associated with R-CECS.

Detailed description

Participants will be enrolled in study at initial clinic visit by study staff at which time diagnosis of R-CECS will be established based on elevated pressure measurements in patients who have had surgical release of the affected compartments. Pressure testing will be performed outside of the clinical study and will be required to establish the diagnosis of R-CECS. Initial clinic visit with study staff will consist of baseline measurements of ankle plantarflexion, dorsiflexion, inversion, and eversion strength using Kiio Force Sensor. The clinic visit with study staff will establish time point 0 and will consist of written consent for participation, Botox injection, and baseline University of Wisconsin Running Index (UWRI). Two months following this visit, the participant will have follow up with study staff. Study staff will again measure ankle strength (ankle inversion, eversion, plantarflexion, and dorsiflexion) using the Kiio Force Sensor utilizing the same strength assessment protocol. Study staff will monitor for side effects and administer the UWRI. Telephone follow up assessment of the UWRI will be made by study staff at 4 and 6 months.

Conditions

• Compartment Syndrome of Leg

Interventions

Type	Name	Description
DRUG	Botox	reconstituted at 100 units/mL, dosage will be based upon the affected muscles

Timeline

• Start date: 2022-11-23
• Primary completion: 2022-11-23
• Completion: 2022-11-23
• First posted: 2021-08-16
• Last updated: 2024-07-18
• Results posted: 2024-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study