Trial Outcomes & Findings for Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome (NCT NCT05006417)

NCT ID: NCT05006417

Last Updated: 2024-07-18

Results Overview

Change in pain score (0-10, where 10 is increased pain) will be assessed at each time point will be assessed at each time point (2, 4, 6 months) using Friedman's ANOVA.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 1 participants
• Primary outcome timeframe: 2 months, 4 months, 6 months
• Results posted on: 2024-07-18

Participant Flow

One participant was enrolled in November of 2022

Participant milestones

Measure	Participants With R-CECS Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Overall Study STARTED	1
Overall Study Baseline Measures	1
Overall Study 2 Months	0
Overall Study 4 Months	0
Overall Study 6 Months	0
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Participants With R-CECS Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Overall Study PI terminated study for problems with strength testing equipment	1

Baseline Characteristics

Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

Baseline characteristics by cohort

Measure	Participants With R-CECS n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months, 4 months, 6 months

Population: only baseline data collected before study was terminated

Change in pain score (0-10, where 10 is increased pain) will be assessed at each time point will be assessed at each time point (2, 4, 6 months) using Friedman's ANOVA.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 6 months

Population: study terminated early

A primary safety endpoint is incidence of lower extremity weakness, measured by

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: one study visit (within 2 hours)

A primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given.

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Incidence of Adverse Events	0 Participants	—

SECONDARY outcome

Timeframe: baseline and month 2

Population: strength equipment not functional, study terminated as a result

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).

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor baseline	24.9 pounds of force	25.2 pounds of force

SECONDARY outcome

Timeframe: baseline and month 2

Population: strength equipment not functional, study terminated as a result

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).

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Change in Ankle Plantarflexion Strength Using Kiio Force Sensor baseline	154.3 pounds of force	156.4 pounds of force

SECONDARY outcome

Timeframe: baseline and month 2

Population: strength equipment not functional, study terminated as a result

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).

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Change in Ankle Inversion Strength Using Kiio Force Sensor baseline	22.9 pounds of force	22.8 pounds of force

SECONDARY outcome

Timeframe: baseline and month 2

Population: strength equipment not functional, study terminated as a result

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).

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Change in Ankle Eversion Strength Using Kiio Force Sensor baseline	22.7 pounds of force	22.8 pounds of force

SECONDARY outcome

Timeframe: baseline, 2 months, 4 months, 6 months

Population: study was terminated after baseline measure

A question on the University of Wisconsin Running Index (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, 1 = significantly impact, 2 = moderately impact, 3 = slightly impact, to 4 = no impact.

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Change in Ability to Perform Activities of Daily Living baseline	2 score on a scale	—

SECONDARY outcome

Timeframe: baseline, 2 months, 4 months, 6 months

Population: study was terminated after baseline measure

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, 1 = significantly frustrated, 2 = moderately frustrated, 3 = mildly frustrated, to 4 = not frustrated.

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Participant Frustration With Injury baseline	0 score on a scale	—

SECONDARY outcome

Timeframe: baseline, 2 months, 4 months, 6 months

Population: study was terminated after baseline measure

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, 1 = minimal recovery, 2 = moderate recovery, 3 = significant recovery, to 4 = complete recovery.

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Participant Perception of Recovery From Injury baseline	0 score on a scale	—

SECONDARY outcome

Timeframe: baseline, 2 months, 4 months, 6 months

Population: study was terminated after baseline measure

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, 1 = significant pain, 2 = moderate pain, 3 = minimal pain, to 4 = no pain.

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Pain in the 24 Hours Following Running baseline	0 score on a scale	—

SECONDARY outcome

Timeframe: baseline, 2 months, 4 months, 6 months

Population: study was terminated after baseline measure

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, 1 = significantly reduced, 2 = moderately reduced, 3 = minimally reduced, to 4 = same or greater than before my injury.

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Change in Running Duration: Weekly baseline	0 score on a scale	—

SECONDARY outcome

Timeframe: baseline, 2 months, 4 months, 6 months

Population: study was terminated after baseline measure

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, 1 = significantly reduced, 2 = moderately reduced, 3 = minimally reduced, to 4 = same or longer than before my injury.

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Change in Running Duration: Longest Run baseline	0 score on a scale	—

SECONDARY outcome

Timeframe: baseline, 2 months, 4 months, 6 months

Population: study was terminated after baseline measure

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, 1 = significantly reduced, 2 = moderately reduced, 3 = minimally reduced, to 4 = same or longer than before my injury.

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Change in Running Speed baseline	0 score on a scale	—

SECONDARY outcome

Timeframe: baseline, 2 months, 4 months, 6 months

Population: study was terminated after baseline measure

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, 1 = if I increase, I might get worse, 2 = neutral, 3 = if I increase I might be fine, to 4 = confident to increase my running.

Outcome measures

Measure	Participants With R-CECS - Left Leg n=1 Participants Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles	Participants With R-CECS - Right Leg Botox to be injected under standard palpatory technique into the affected lower leg compartment. Botox: reconstituted at 100 units/mL, dosage will be based upon the affected muscles
Participant Confidence in Increasing the Duration and Intensity of Running baseline	0 score on a scale	—

Adverse Events

Participants With R-CECS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Suer, MD

UW School of Medicine and Public Health

Phone: (608) 265-3207

Email: suer@rehab.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place