Chronic Exertional Compartment SyndromePhase 2/3BotoxNCT03339921
Botulinum for Chronic Exertional Compartment Syndrome
A Phase 2/3 study testing Botulinum toxin injections for chronic compartment syndrome and surgical fasciotomy for chronic compartment syndrome in people with Chronic Exertional Compartment Syndrome, run by 375th Medical Group, Scott Air Force Base at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Exertional Compartment Syndrome
- What is being tested?
- Botulinum toxin injections for chronic compartment syndrome and surgical fasciotomy for chronic compartment syndrome
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 1 May 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
375th Medical Group
Scott Air Force Base, Illinois, 62225
About this study
Official title: Comparison of Botulinum Toxin to Fasciotomy in Treatment of Chronic Exertional Compartment Syndrome
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.
Read the 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.
- Conditions
- Chronic Exertional Compartment Syndrome
- Being tested
- Botulinum toxin injections for chronic compartment syndrome, surgical fasciotomy for chronic compartment syndrome
- Medical subject headings
- Chronic Exertional Compartment Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injections for chronic compartment syndromeDrug
Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe
surgical fasciotomy for chronic compartment syndromeProcedure or surgery
linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin injections | Experimental | Botulinum toxin injections for chronic compartment syndrome Receives: Drug: Botulinum toxin injections for chronic compartment syndrome |
| surgical fasciotomy | Active comparator | surgical fasciotomy for chronic compartment syndrome Receives: Procedure: surgical fasciotomy for chronic compartment syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start7 Dec 2018
- Primary completion1 May 2020
- Study completion1 May 2020
Why it stopped: This study is being closed because it is unworkable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Exertional Compartment SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- 375th Medical Group, Scott Air Force Base
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Brett Boyce, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339921
- Sponsor's protocol ID
- FWH20170037H
- Acronym
- Botox
- Status last verified
- Mar 2024
- First submitted
- 8 Nov 2017
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Botulinum Toxin to Fasciotomy in Treatment of Chronic Exertional Compartment Syndrome
- ClinicalTrials.gov ID
- NCT03339921
- Acronym / sponsor ID
- Botox / FWH20170037H
- Conditions
- Chronic Exertional Compartment Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study is being closed because it is unworkable.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- 375th Medical Group, Scott Air Force BaseUS federal agency
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin injections | Experimental | Drug: Botulinum toxin injections for chronic compartment syndromeBotulinum toxin injections for chronic compartment syndrome |
| surgical fasciotomy | Active comparator | Procedure: surgical fasciotomy for chronic compartment syndromesurgical fasciotomy for chronic compartment syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin injections for chronic compartment syndromeBotulinum toxin will be injected in the upper and lower portion of the affected area with a syringe | Drug | Botulinum toxin injections |
| surgical fasciotomy for chronic compartment syndromelinear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment | Procedure or surgery | surgical fasciotomy |
Primary outcome
Lower Extremity Functional Index
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Exertional Compartment Syndrome
Recruiting
Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?
Compartment Syndrome Nontraumatic Lower Leg
Recruiting
Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.
Chronic Exertional Compartment Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Boyce, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botulinum toxin injections for chronic compartment syndrome and surgical fasciotomy for chronic compartment syndrome in people with Chronic Exertional Compartment Syndrome, run by 375th Medical Group, Scott Air Force Base at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Functional Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.