Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

Compartment Syndrome of Leg Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05006417
• Other study ID #: 2020-1375
• Secondary ID: Protocol Version
• Status: Suspended
• Phase: Phase 4
• Start date: November 23, 2022
• Est. completion date: January 2024

Study information

• Verified date: June 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Exertional Compartment Syndrome
• Compartment Syndrome of Leg
• Compartment Syndromes
• Syndrome

Intervention

Drug:
• Botox
reconstituted at 100 units/mL, dosage will be based upon the affected muscles

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Score	Change in pain (from baseline on 0-10 numeric rating scale where higher numbers indicate increased pain) will be assessed at each time point (2,4,6 months) using Friedman's ANOVA.	baseline, 2 months, 4 months, 6 months
Primary	Number of Participants with Lower Extremity Weakness	A primary safety endpoint is incidence of lower extremity weakness, measured by	up to 6 months
Primary	Incidence of Adverse Events	A primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given.	up to 6 months
Secondary	Change in ankle dorsiflexion strength using Kiio Force Sensor	A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).	baseline and month 2
Secondary	Change in ankle plantarflexion strength using Kiio Force Sensor	A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).	baseline and month 2
Secondary	Change in ankle inversion strength using Kiio Force Sensor	A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).	baseline and month 2
Secondary	Change in ankle eversion strength using Kiio Force Sensor	A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).	baseline and month 2
Secondary	Change in ability to perform activities of daily living	A question on the UWRI asks the participant to indicate how their running injury impacts their ability to perform daily activities. The scoring is on a 5 point likert scale from 0 = unable to perform to 4 = no impact.	baseline, 2 months, 4 months, 6 months
Secondary	Participant frustration with injury	A question on the UWRI asks the participant to indicate how frustrated they are by their running injury. The scoring is on a 5 point likert scale from 0 = extremely frustrated to 4 = not frustrated.	baseline, 2 months, 4 months, 6 months
Secondary	Participant perception of recovery from injury	A question on the UWRI asks the participant to indicate how much recovery have they made from their running injury. The scoring is on a 5 point likert scale from 0 = no recovery to 4 = complete recovery.	baseline, 2 months, 4 months, 6 months
Secondary	Pain in the 24 hours following running	A question on the UWRI asks the participant to indicate how much pain they experience during the 24 hours following a run. The scoring is on a 5 point likert scale from 0 = unable to run to 4 = no pain.	baseline, 2 months, 4 months, 6 months
Secondary	Change in running duration: weekly	A question on the UWRI asks the participant to indicate if their weekly mileage or weekly running time changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run to 4 = same or greater than before my injury.	baseline, 2 months, 4 months, 6 months
Secondary	Change in running duration: longest run	A question on the UWRI asks the participant to indicate if the distance of their longest weekly run has changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run to 4 = same or longer than before my injury.	baseline, 2 months, 4 months, 6 months
Secondary	Change in running speed	A question on the UWRI asks the participant to indicate if the distance of their longest weekly run has changed as a result of their injury. The scoring is on a 5 point likert scale from 0 = unable to run to 4 = same or longer than before my injury.	baseline, 2 months, 4 months, 6 months
Secondary	Participant confidence in increasing the duration and intensity of running	A question on the UWRI asks the participant to indicate how their injury affects their confidence to increase the duration or intensity of their running. The scoring is on a 5 point likert scale from 0 = I cannot increase my running to 4 = confident to increase my running.	baseline, 2 months, 4 months, 6 months