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This study is being closed because it is unworkable.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin injections | Experimental | Botulinum toxin injections for chronic compartment syndrome |
|
| surgical fasciotomy | Active Comparator | surgical fasciotomy for chronic compartment syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin injections for chronic compartment syndrome | Drug | Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett Boyce, MD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 375th Medical Group | Scott Air Force Base | Illinois | 62225 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study was terminated because it is unworkable.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Surgical Fasciotomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No subjects were analyzed by a biostatistician. This study was terminated because it is unworkable. Raw data are reported. | Posted | Mean | Full Range | score on a scale | 6 months |
|
6 months
This study was terminated because it is unworkable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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This study was terminated because it is unworkable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Crawford | MOMH | 7026533583 | amanda.j.rawford.ctr@health.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2020 | Jan 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083182 | Chronic Exertional Compartment Syndrome |
| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
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| surgical fasciotomy for chronic compartment syndrome | Procedure | linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D002318 |
| Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |