Chronic Exertional Compartment Syndrome
Conditions
Brief summary
We will investigate the feasibility of a simple outpatient one time injection regimen for the treatment of Chronic Exertional Compartment Syndrome (CECS). We think botulinum toxin injections will be a potentially cost-effective, low-risk alternative to surgery in reducing pain and returning patients to full activity.
Detailed description
The study will be a prospective cohort pilot study designed to compare Active Duty patients, 18 years of age or older, with Chronic Exertional Compartment Syndrome (CECS) undergoing two different treatment interventions. The first arm will be patients receiving investigational botulinum toxin injections. The second arm will be patients who undergo the standard of care surgical fasciotomy. Both arms will be evaluated for pain relief with the universal pain scale and lower extremity functional index (LEFI) surveys at pre-treatment and again at one, three, and six months post-treatment. Clinical data that will be analyzed for research purposes in both groups include age, sex, height, weight, body mass index, time to diagnosis, minutes of exercise prior to onset of symptoms, minutes of rest before relief of symptoms, LEFI and pain on the Universal Pain Assessment Tool.
Interventions
DRUGBotulinum toxin injections for chronic compartment syndrome
Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe
PROCEDUREsurgical fasciotomy for chronic compartment syndrome
linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment
Sponsors
375th Medical Group, Scott Air Force Base
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult ages 18-65 * Active duty military * Unable to run 1.5 miles without producing symptoms, including aching, burning, numbness, tingling, or weakness in the affected limb * Failed conservative treatment over a period of 2 months, including trial of rest, NSAIDs, icing, and stretching routine * Meets standard of care clinical diagnostic intramuscular compartment pressure criteria for CECS, based on standardized IMP needle testing. See below for testing protocol and criteria.
Exclusion criteria
* Prior Botulinum toxin injections into the affected limb * Prior compartment release of the affected limb * Pregnant or becomes pregnant during the study * Standard of care clinical exams indicating other more likely causes of leg pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower Extremity Functional Index | 6 months | The Lower Extremity Functional Index measures the functional impairment of a patient with a lower extremity disorder. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. Score ranges from 0 to 80. Lower scores indicate more functional impairment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Injections Botulinum toxin injections for chronic compartment syndrome
Botulinum toxin injections for chronic compartment syndrome: Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe | 3 |
| Surgical Fasciotomy surgical fasciotomy for chronic compartment syndrome
surgical fasciotomy for chronic compartment syndrome: linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Botulinum Toxin Injections | Surgical Fasciotomy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 3 participants | — | 3 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
Lower Extremity Functional Index
The Lower Extremity Functional Index measures the functional impairment of a patient with a lower extremity disorder. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. Score ranges from 0 to 80. Lower scores indicate more functional impairment.
Time frame: 6 months
Population: No subjects were analyzed by a biostatistician. This study was terminated because it is unworkable. Raw data are reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botulinum Toxin Injections | Lower Extremity Functional Index | Lower Extremity Functional Scale Immediately Post Treatment | 57 score on a scale |
| Botulinum Toxin Injections | Lower Extremity Functional Index | Lower Extremity Functional Scale Month 1 | 60 score on a scale |
| Botulinum Toxin Injections | Lower Extremity Functional Index | Lower Extremity Functional Scale Month 2 | 62 score on a scale |
| Botulinum Toxin Injections | Lower Extremity Functional Index | Lower Extremity Functional Scale Month 6 | 55 score on a scale |