Clinical trial NCT05006417: Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome
Official title: OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Compartment Syndrome of Leg
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Willing to provide written informed consent
* Willing to comply with all study procedures and be available for the duration of the study
* Documented diagnosis of R-CECS determined with elevated compartmental pressure testing following lower extremity fascia release (fasciotomy or fasciectomy)
* 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 randomization, for the duration of study participation, and for 7 days following completion of therapy.

  * 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).

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
* Enrolled in another clinical trial or has used of 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. Currently taking any blood-thinning medications including, but not limited to Plavix, Coumadin, Eliquis, Xarelto
* Women who are pregnant or breast-feeding
* Vulnerable populations
* Not suitable for study participation due to other reasons at the discretion of the investigator

Primary outcomes:
measure: Change in Pain Score
timeFrame: 2 months, 4 months, 6 months
measure: Number of Participants With Lower Extremity Weakness
timeFrame: up to 6 months
measure: Incidence of Adverse Events
timeFrame: one study visit (within 2 hours)
Secondary outcomes:
measure: Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor
timeFrame: baseline and month 2
measure: Change in Ankle Plantarflexion Strength Using Kiio Force Sensor
timeFrame: baseline and month 2
measure: Change in Ankle Inversion Strength Using Kiio Force Sensor
timeFrame: baseline and month 2
measure: Change in Ankle Eversion Strength Using Kiio Force Sensor
timeFrame: baseline and month 2
measure: Change in Ability to Perform Activities of Daily Living
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Participant Frustration With Injury
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Participant Perception of Recovery From Injury
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Pain in the 24 Hours Following Running
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change in Running Duration: Weekly
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change in Running Duration: Longest Run
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Change in Running Speed
timeFrame: baseline, 2 months, 4 months, 6 months
measure: Participant Confidence in Increasing the Duration and Intensity of Running
timeFrame: baseline, 2 months, 4 months, 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Suer, MD
role: PRINCIPAL_INVESTIGATOR
References: