OnabotulinumtoxinA (Botox) Effect on Pain and Return to Sport in Chronic Exertional Compartment Syndrome of the Anterior Leg: A Pilot Study

2017-1061

After diagnosis of Chronic Exertional Compartment Syndrome (CECS), the participants will be referred to both physical therapy and Botox injection. In physical therapy, the therapist will perform strength measurements of the lower leg (ankle plantarflexion and dorsiflexion) which will be repeated 2 months following the injection. An ultrasound-guided injection of 50 units of Botox will be administered into the tibialis anterior. 25 units will be injected into two different spots in the muscle one being more proximal and the other distal. This will be a one-time injection and will be observed as to how it effects participant symptoms over the next 6 months at either a clinic visit (at 2 months) or telephone call (at 4 and 6 months after injection) via the University of Wisconsin Running Index. Two months following the injection, the participant will undergo repeat measurements of strength using the Kiio Force Sensor. Should potential participants of childbearing potential wish to enroll in the study, a urine pregnancy test will be performed prior to enrollment; participants will not be enrolled if test is positive.

2019-10-08

2021-12-15

2021-12-15

Terminated

Early phase I

7

Inclusion Criteria: * Willing to provide written informed consent * Willing to comply with all study procedures and be available for the duration of the study including reliable use of telephone for communication * Male or female, at least 18 years of age * Documented diagnosis of CECS * Females of childbearing potential must have a negative urine pregnancy test prior to enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to enrollment and for the duration of study participation. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 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). * Be involved, either competitively or non-competitively, in an activity requiring significant running as determined by the PI Exclusion Criteria: * History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes * Known neuromuscular disease * Known pulmonary disease including but not limited to asthma, pneumonia, or upper respiratory tract infection * Dysphagia * Known cardiac disease including but not limited to congestive heart failure, arrhythmia, or history of myocardial infarction * History of lower extremity fasciotomy * Enrolled in another clinical trial or has used any investigational drugs, biologics, or devices within 30 days prior to enrollment * Currently or have taken in the past medications that affect neuromuscular function: aminoglycosides, muscle relaxants, or other botulinum neurotoxin agents * Women who are pregnant or breast-feeding * Vulnerable populations * Not suitable for study participation due to other reasons at the discretion of the investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}

2023-02-14