Trial Outcomes & Findings for Botox for the Treatment of Chronic Exertional Compartment Syndrome (NCT NCT03922139)
NCT ID: NCT03922139
Last Updated: 2023-02-14
Results Overview
Percentage of Relief of Pain will be assessed at each time point (2,4,6 months) using Friedman's ANOVA.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Baseline, 2 months, 4 months and 6 months
Results posted on
2023-02-14
Participant Flow
Participants were recruited at the University of Wisconsin - Madison from October 2019 to February 2021.
Participant milestones
| Measure |
Botox
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
Completed 2 Month Surveys
|
7
|
|
Overall Study
Completed 4 Month Surveys
|
6
|
|
Overall Study
Completed 6 Month Surveys
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Botox for the Treatment of Chronic Exertional Compartment Syndrome
Baseline characteristics by cohort
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 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
|
1 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
|
6 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
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 months, 4 months and 6 monthsPopulation: not all participants completed the assessment for all time points
Percentage of Relief of Pain will be assessed at each time point (2,4,6 months) using Friedman's ANOVA.
Outcome measures
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Percentage of Relief of Pain
Baseline
|
0 percentage relief of pain
Interval 0.0 to 0.0
|
|
Percentage of Relief of Pain
2 months
|
80.7 percentage relief of pain
Interval 0.0 to 100.0
|
|
Percentage of Relief of Pain
4 months
|
100 percentage relief of pain
Interval 100.0 to 100.0
|
|
Percentage of Relief of Pain
6 months
|
100 percentage relief of pain
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: one participant dropped from the study
A primary safety endpoint is the incidence of lower extremity weakness
Outcome measures
| Measure |
Botox
n=6 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Number of Participants With Lower Extremity Weakness
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsA 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 |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Incidence of Adverse Events
|
0 number of adverse events
|
SECONDARY outcome
Timeframe: baseline and month 2Population: one participant did not return for 2 month measures
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 |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Change in Ankle Dorisflexsion Strength Using Kiio Force Sensor
baseline right ankle
|
24.6 degrees
Interval 22.9 to 26.9
|
|
Change in Ankle Dorisflexsion Strength Using Kiio Force Sensor
2 months right ankle
|
25.0 degrees
Interval 23.4 to 27.1
|
|
Change in Ankle Dorisflexsion Strength Using Kiio Force Sensor
baseline left ankle
|
24.6 degrees
Interval 22.8 to 27.1
|
|
Change in Ankle Dorisflexsion Strength Using Kiio Force Sensor
2 months left ankle
|
25.2 degrees
Interval 23.5 to 27.3
|
SECONDARY outcome
Timeframe: baseline and month 2Population: one participant did not return for 2 month measures
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 |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Change in Ankle Plantarflexion Strength Using Kiio Force Sensor
2 months right ankle
|
177.0 degrees
Interval 162.4 to 192.6
|
|
Change in Ankle Plantarflexion Strength Using Kiio Force Sensor
baseline left ankle
|
172.5 degrees
Interval 158.1 to 190.1
|
|
Change in Ankle Plantarflexion Strength Using Kiio Force Sensor
baseline right ankle
|
173.8 degrees
Interval 158.4 to 192.0
|
|
Change in Ankle Plantarflexion Strength Using Kiio Force Sensor
2 months left ankle
|
176.5 degrees
Interval 162.1 to 191.8
|
SECONDARY outcome
Timeframe: baseline and month 2Population: one participant did not return for 2 month measures
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 |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Change in Ankle Inversion Strength Using Kiio Force Sensor
2 months right ankle
|
23.1 degrees
Interval 21.9 to 25.0
|
|
Change in Ankle Inversion Strength Using Kiio Force Sensor
Baseline left ankle
|
22.4 degrees
Interval 20.8 to 25.0
|
|
Change in Ankle Inversion Strength Using Kiio Force Sensor
baseline right ankle
|
22.6 degrees
Interval 21.0 to 24.9
|
|
Change in Ankle Inversion Strength Using Kiio Force Sensor
2 months left ankle
|
22.9 degrees
Interval 21.8 to 25.2
|
SECONDARY outcome
Timeframe: baseline and month 2Population: one participant did not return for 2 month measures
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 |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Change in Ankle Eversion Strength Using Kiio Force Sensor
baseline left ankle
|
22.8 degrees
Interval 20.9 to 25.2
|
|
Change in Ankle Eversion Strength Using Kiio Force Sensor
baseline right ankle
|
22.7 degrees
Interval 20.9 to 25.3
|
|
Change in Ankle Eversion Strength Using Kiio Force Sensor
2 months left ankle
|
23.3 degrees
Interval 21.0 to 25.4
|
|
Change in Ankle Eversion Strength Using Kiio Force Sensor
2 months right ankle
|
23.3 degrees
Interval 21.2 to 25.5
|
SECONDARY outcome
Timeframe: baseline, 2 months, 4 months, 6 monthsPopulation: One participant did not answer the 4 month survey
A question on the UWRI asks the participant to indicate how their running injury impacts their ability to perform daily activities: No Impact, Slightly Impact, Moderately Impact, Significantly Impact, Unable to Perform.
Outcome measures
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Change in Ability to Perform Activities of Daily Living
baseline · No Impact
|
2 Participants
|
|
Change in Ability to Perform Activities of Daily Living
baseline · Slightly Impact
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
baseline · Moderately Impact
|
2 Participants
|
|
Change in Ability to Perform Activities of Daily Living
baseline · Significantly Impact
|
3 Participants
|
|
Change in Ability to Perform Activities of Daily Living
baseline · Unable to Perform
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
2 months · No Impact
|
4 Participants
|
|
Change in Ability to Perform Activities of Daily Living
2 months · Slightly Impact
|
3 Participants
|
|
Change in Ability to Perform Activities of Daily Living
2 months · Moderately Impact
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
2 months · Significantly Impact
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
2 months · Unable to Perform
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
4 months · No Impact
|
6 Participants
|
|
Change in Ability to Perform Activities of Daily Living
4 months · Slightly Impact
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
4 months · Moderately Impact
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
4 months · Significantly Impact
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
4 months · Unable to Perform
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
6 months · No Impact
|
7 Participants
|
|
Change in Ability to Perform Activities of Daily Living
6 months · Slightly Impact
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
6 months · Moderately Impact
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
6 months · Significantly Impact
|
0 Participants
|
|
Change in Ability to Perform Activities of Daily Living
6 months · Unable to Perform
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 months, 4 months, 6 monthsPopulation: one participant did not answer 4 month survey
A question on the UWRI asks the participant to indicate how frustrated they are by their running injury: Not frustrated, Mildly frustrated, Moderately frustrated, Significantly frustrated, or Extremely frustrated.
Outcome measures
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Participant Frustration With Injury
2 months · Extremely Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
4 months · Not Frustrated
|
5 Participants
|
|
Participant Frustration With Injury
baseline · Not Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
baseline · Mildly Frustrated
|
1 Participants
|
|
Participant Frustration With Injury
baseline · Moderately Frustrated
|
1 Participants
|
|
Participant Frustration With Injury
baseline · Significantly Frustrated
|
1 Participants
|
|
Participant Frustration With Injury
baseline · Extremely Frustrated
|
4 Participants
|
|
Participant Frustration With Injury
2 months · Not Frustrated
|
5 Participants
|
|
Participant Frustration With Injury
2 months · Mildly Frustrated
|
2 Participants
|
|
Participant Frustration With Injury
2 months · Moderately Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
2 months · Significantly Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
4 months · Mildly Frustrated
|
1 Participants
|
|
Participant Frustration With Injury
4 months · Moderately Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
4 months · Significantly Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
4 months · Extremely Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
6 months · Not Frustrated
|
7 Participants
|
|
Participant Frustration With Injury
6 months · Mildly Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
6 months · Moderately Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
6 months · Significantly Frustrated
|
0 Participants
|
|
Participant Frustration With Injury
6 months · Extremely Frustrated
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 months, 4 months, 6 monthsPopulation: One participant did not answer the 4 month survey.
A question on the UWRI asks the participant to indicate how much recovery have they made from their running injury: Complete Recovery, Significant Recovery, Moderate Recovery, Minimal Recovery, No Recovery.
Outcome measures
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Participant Perception of Recovery From Injury
baseline · Complete Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
baseline · Significant Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
baseline · Moderate Recovery
|
1 Participants
|
|
Participant Perception of Recovery From Injury
baseline · Minimal Recovery
|
1 Participants
|
|
Participant Perception of Recovery From Injury
baseline · No Recovery
|
5 Participants
|
|
Participant Perception of Recovery From Injury
2 months · Complete Recovery
|
3 Participants
|
|
Participant Perception of Recovery From Injury
2 months · Significant Recovery
|
4 Participants
|
|
Participant Perception of Recovery From Injury
2 months · Moderate Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
2 months · Minimal Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
2 months · No Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
4 months · Complete Recovery
|
5 Participants
|
|
Participant Perception of Recovery From Injury
4 months · Significant Recovery
|
1 Participants
|
|
Participant Perception of Recovery From Injury
4 months · Moderate Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
4 months · Minimal Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
4 months · No Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
6 months · Complete Recovery
|
7 Participants
|
|
Participant Perception of Recovery From Injury
6 months · Significant Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
6 months · Moderate Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
6 months · Minimal Recovery
|
0 Participants
|
|
Participant Perception of Recovery From Injury
6 months · No Recovery
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 months, 4 months, 6 monthsPopulation: One participant did not complete the 4 month survey
A question on the UWRI asks the participant to indicate how much pain they experience during the 24 hours following a run: No pain, Minimal pain, Moderate pain, Significant pain, Unable to Run.
Outcome measures
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Pain in the 24 Hours Following Running
2 months · No Pain
|
7 Participants
|
|
Pain in the 24 Hours Following Running
2 months · Minimal Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
2 months · Moderate Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
baseline · No Pain
|
2 Participants
|
|
Pain in the 24 Hours Following Running
baseline · Minimal Pain
|
3 Participants
|
|
Pain in the 24 Hours Following Running
baseline · Moderate Pain
|
1 Participants
|
|
Pain in the 24 Hours Following Running
baseline · Significant Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
baseline · Unable to Run
|
1 Participants
|
|
Pain in the 24 Hours Following Running
2 months · Significant Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
2 months · Unable to Run
|
0 Participants
|
|
Pain in the 24 Hours Following Running
4 months · No Pain
|
6 Participants
|
|
Pain in the 24 Hours Following Running
4 months · Minimal Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
4 months · Moderate Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
4 months · Significant Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
4 months · Unable to Run
|
0 Participants
|
|
Pain in the 24 Hours Following Running
6 months · No Pain
|
7 Participants
|
|
Pain in the 24 Hours Following Running
6 months · Minimal Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
6 months · Moderate Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
6 months · Significant Pain
|
0 Participants
|
|
Pain in the 24 Hours Following Running
6 months · Unable to Run
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 months, 4 months, 6 monthsPopulation: One participant did not complete the 4 month survey.
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: Same or greater than before injury, Minimally reduced, Moderately reduced, Significantly reduced, Unable to Run.
Outcome measures
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Change in Running Duration: Weekly
6 months · Moderately reduced
|
0 Participants
|
|
Change in Running Duration: Weekly
6 months · Significantly reduced
|
0 Participants
|
|
Change in Running Duration: Weekly
6 months · Unable to Run
|
0 Participants
|
|
Change in Running Duration: Weekly
baseline · Same or greater than before injury
|
0 Participants
|
|
Change in Running Duration: Weekly
baseline · Minimally reduced
|
0 Participants
|
|
Change in Running Duration: Weekly
baseline · Moderately reduced
|
2 Participants
|
|
Change in Running Duration: Weekly
baseline · Significantly reduced
|
3 Participants
|
|
Change in Running Duration: Weekly
baseline · Unable to Run
|
2 Participants
|
|
Change in Running Duration: Weekly
2 months · Same or greater than before injury
|
6 Participants
|
|
Change in Running Duration: Weekly
2 months · Minimally reduced
|
1 Participants
|
|
Change in Running Duration: Weekly
2 months · Moderately reduced
|
0 Participants
|
|
Change in Running Duration: Weekly
2 months · Significantly reduced
|
0 Participants
|
|
Change in Running Duration: Weekly
2 months · Unable to Run
|
0 Participants
|
|
Change in Running Duration: Weekly
4 months · Same or greater than before injury
|
6 Participants
|
|
Change in Running Duration: Weekly
4 months · Minimally reduced
|
0 Participants
|
|
Change in Running Duration: Weekly
4 months · Moderately reduced
|
0 Participants
|
|
Change in Running Duration: Weekly
4 months · Significantly reduced
|
0 Participants
|
|
Change in Running Duration: Weekly
4 months · Unable to Run
|
0 Participants
|
|
Change in Running Duration: Weekly
6 months · Same or greater than before injury
|
7 Participants
|
|
Change in Running Duration: Weekly
6 months · Minimally reduced
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 months, 4 months, 6 monthsPopulation: One participant did not complete the 4 month survey.
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: Same or longer than before my injury, Minimally reduced, Moderately reduced, Significantly reduced, Unable to Run.
Outcome measures
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Change in Running Duration: Longest Run
baseline · Same or longer than before my injury
|
1 Participants
|
|
Change in Running Duration: Longest Run
baseline · Minimally reduced
|
0 Participants
|
|
Change in Running Duration: Longest Run
baseline · Moderately reduced
|
2 Participants
|
|
Change in Running Duration: Longest Run
baseline · Significantly reduced
|
4 Participants
|
|
Change in Running Duration: Longest Run
baseline · Unable to Run
|
0 Participants
|
|
Change in Running Duration: Longest Run
2 months · Same or longer than before my injury
|
6 Participants
|
|
Change in Running Duration: Longest Run
2 months · Minimally reduced
|
1 Participants
|
|
Change in Running Duration: Longest Run
2 months · Moderately reduced
|
0 Participants
|
|
Change in Running Duration: Longest Run
2 months · Significantly reduced
|
0 Participants
|
|
Change in Running Duration: Longest Run
2 months · Unable to Run
|
0 Participants
|
|
Change in Running Duration: Longest Run
4 months · Same or longer than before my injury
|
6 Participants
|
|
Change in Running Duration: Longest Run
4 months · Minimally reduced
|
0 Participants
|
|
Change in Running Duration: Longest Run
4 months · Moderately reduced
|
0 Participants
|
|
Change in Running Duration: Longest Run
4 months · Significantly reduced
|
0 Participants
|
|
Change in Running Duration: Longest Run
4 months · Unable to Run
|
0 Participants
|
|
Change in Running Duration: Longest Run
6 months · Same or longer than before my injury
|
7 Participants
|
|
Change in Running Duration: Longest Run
6 months · Minimally reduced
|
0 Participants
|
|
Change in Running Duration: Longest Run
6 months · Moderately reduced
|
0 Participants
|
|
Change in Running Duration: Longest Run
6 months · Significantly reduced
|
0 Participants
|
|
Change in Running Duration: Longest Run
6 months · Unable to Run
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 months, 4 months, 6 monthsPopulation: One participant did not complete the 4 month survey.
A question on the UWRI asks the participant to indicate if the distance of the longest weekly run has changed as a result of their injury: Same or faster than before my injury, Minimally reduced, Moderately reduced, Significantly reduced, Unable to Run.
Outcome measures
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Change in Running Speed
2 months · Moderately reduced
|
0 Participants
|
|
Change in Running Speed
2 months · Significantly reduced
|
0 Participants
|
|
Change in Running Speed
2 months · Unable to Run
|
0 Participants
|
|
Change in Running Speed
4 months · Same or faster than before my injury
|
6 Participants
|
|
Change in Running Speed
4 months · Minimally reduced
|
0 Participants
|
|
Change in Running Speed
4 months · Moderately reduced
|
0 Participants
|
|
Change in Running Speed
4 months · Significantly reduced
|
0 Participants
|
|
Change in Running Speed
4 months · Unable to Run
|
0 Participants
|
|
Change in Running Speed
6 months · Same or faster than before my injury
|
7 Participants
|
|
Change in Running Speed
6 months · Minimally reduced
|
0 Participants
|
|
Change in Running Speed
6 months · Moderately reduced
|
0 Participants
|
|
Change in Running Speed
6 months · Significantly reduced
|
0 Participants
|
|
Change in Running Speed
6 months · Unable to Run
|
0 Participants
|
|
Change in Running Speed
baseline · Same or faster than before my injury
|
0 Participants
|
|
Change in Running Speed
baseline · Minimally reduced
|
2 Participants
|
|
Change in Running Speed
baseline · Moderately reduced
|
1 Participants
|
|
Change in Running Speed
baseline · Significantly reduced
|
2 Participants
|
|
Change in Running Speed
baseline · Unable to Run
|
2 Participants
|
|
Change in Running Speed
2 months · Same or faster than before my injury
|
7 Participants
|
|
Change in Running Speed
2 months · Minimally reduced
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 months, 4 months, 6 monthsPopulation: One participant did not complete the 4 month survey.
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: Confident to increase my running, If I increase I might be fine, Neutral, If I increase I might get worse, I cannot increase my running.
Outcome measures
| Measure |
Botox
n=7 Participants
Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection.
25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
|
|---|---|
|
Participant Confidence in Increasing the Duration and Intensity of Running
6 months · I cannot increase my running
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
baseline · Confident to increase my running
|
1 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
baseline · If I increase I might be fine
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
baseline · Neutral
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
baseline · If I increase I might get worse
|
3 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
baseline · I cannot increase my running
|
3 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
2 months · Confident to increase my running
|
5 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
2 months · If I increase I might be fine
|
1 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
2 months · Neutral
|
1 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
2 months · If I increase I might get worse
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
2 months · I cannot increase my running
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
4 months · Confident to increase my running
|
6 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
4 months · If I increase I might be fine
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
4 months · Neutral
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
4 months · If I increase I might get worse
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
4 months · I cannot increase my running
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
6 months · Confident to increase my running
|
7 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
6 months · If I increase I might be fine
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
6 months · Neutral
|
0 Participants
|
|
Participant Confidence in Increasing the Duration and Intensity of Running
6 months · If I increase I might get worse
|
0 Participants
|
Adverse Events
Botox
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: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place