Chronic Exertional Compartment SyndromeNCT03736174
Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome
An observational study of Chronic Exertional Compartment Syndrome, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to investigate high frequency ultrasound as a future modality for the diagnosis of chronic exertional compartment syndrome (CECS). The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Chronic Exertional Compartment Syndrome
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are seen at the University of Colorado Sports Medicine Clinic who present with symptoms of CECS.
Who may be able to join
- Male or female ages 13 and over
- Patients with any combination of the following symptoms who would otherwise be evaluated for CECS:
- Symptoms of leg pain worsened with activity and relieved by rest
- Pain that is generalized in the anterior or lateral compartments of lower leg
- Numbness or tingling in the distribution of the superficial peroneal nerve
- Sensation of "slap foot" or anterior/lateral compartment weakness
- Able to exercise for CPT testing: Patients will be asked to go through a standardized warm up on a treadmill with increasing speed and incline settings until symptoms are achieved. They will maintain exercise for a minimum of five minutes or to patient tolerance.
Who cannot join
- Known vascular disease
- Neurogenic or radicular symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado - Sports Medicine
Denver, Colorado, 80222
About this study
Official title: The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study
The purpose of this study is to investigate high frequency ultrasound as a future modality for the diagnosis of chronic exertional compartment syndrome (CECS). The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS.
Read the detailed description
The purpose of this study is to investigate high frequency ultrasound as a future modality for the diagnosis of chronic exertional compartment syndrome (CECS). The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compartment thickness at its largest dimension. A specific aim for this study would be to facilitate future research in order to eliminate the need for painful and invasive diagnostic techniques for CECS.
- Conditions
- Chronic Exertional Compartment Syndrome
- Keywords
- CECS
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Compartment Pressure Testing | Patients who present with symptoms of CECS will be consented and tested per protocol with compartment pressure testing. Concurrently, patients will undergo a high frequency ultrasound to observe any patterns in structure to assist future research in noninvasively diagnosing CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compartment thickness at its largest dimension. | |
| Control | Control subjects will undergo exercise protocol and ultrasound, but will not have compartment pressure testing completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound to predict/diagnose CECS
Determine if there are significant radiologic patterns arising on ultrasound imaging to help further future research predict or diagnose CECS using non-invasive methods.Specific aim is to investigate high frequency ultrasound as a future modality for the diagnosis of CECS. The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start7 Dec 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Exertional Compartment SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Wolcott, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736174
- Sponsor's protocol ID
- 18-1297
- Status last verified
- Apr 2023
- First submitted
- 30 Oct 2018
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aweid O, Del Buono A, Malliaras P, Iqbal H, Morrissey D, Maffulli N, Padhiar N. Systematic review and recommendations for intracompartmental pressure monitoring in diagnosing chronic exertional compartment syndrome of the leg. Clin J Sport Med. 2012 Jul;22(4):356-70. doi: 10.1097/JSM.0b013e3182580e1d.
PubMed 22627653Barnes M. Diagnosis and management of chronic compartment syndromes: a review of the literature. Br J Sports Med. 1997 Mar;31(1):21-7. doi: 10.1136/bjsm.31.1.21. No abstract available.
PubMed 9132204Fraipont MJ, Adamson GJ. Chronic exertional compartment syndrome. J Am Acad Orthop Surg. 2003 Jul-Aug;11(4):268-76. doi: 10.5435/00124635-200307000-00006.
PubMed 12889865Gershuni DH, Gosink BB, Hargens AR, Gould RN, Forsythe JR, Mubarak SJ, Akeson WH. Ultrasound evaluation of the anterior musculofascial compartment of the leg following exercise. Clin Orthop Relat Res. 1982 Jul;(167):185-90.
PubMed 7094462Lynch JE, Heyman JS, Hargens AR. Ultrasonic device for the noninvasive diagnosis of compartment syndrome. Physiol Meas. 2004 Feb;25(1):N1-9. doi: 10.1088/0967-3334/25/1/n01.
PubMed 15005334Paik RS, Pepple DA, Hutchinson MR. Chronic exertional compartment syndrome. BMJ. 2013 Jan 15;346:f33. doi: 10.1136/bmj.f33. No abstract available.
PubMed 23321416Pedowitz RA, Hargens AR, Mubarak SJ, Gershuni DH. Modified criteria for the objective diagnosis of chronic compartment syndrome of the leg. Am J Sports Med. 1990 Jan-Feb;18(1):35-40. doi: 10.1177/036354659001800106.
PubMed 2301689Rajasekaran S, Beavis C, Aly AR, Leswick D. The utility of ultrasound in detecting anterior compartment thickness changes in chronic exertional compartment syndrome: a pilot study. Clin J Sport Med. 2013 Jul;23(4):305-11. doi: 10.1097/JSM.0b013e3182856046.
PubMed 23558330Roberts A, Franklyn-Miller A. The validity of the diagnostic criteria used in chronic exertional compartment syndrome: a systematic review. Scand J Med Sci Sports. 2012 Oct;22(5):585-95. doi: 10.1111/j.1600-0838.2011.01386.x. Epub 2011 Sep 13.
PubMed 22092446Roscoe D, Roberts AJ, Hulse D. Intramuscular compartment pressure measurement in chronic exertional compartment syndrome: new and improved diagnostic criteria. Am J Sports Med. 2015 Feb;43(2):392-8. doi: 10.1177/0363546514555970. Epub 2014 Nov 18.
PubMed 25406302Tucker AK. Chronic exertional compartment syndrome of the leg. Curr Rev Musculoskelet Med. 2010 Sep 2;3(1-4):32-7. doi: 10.1007/s12178-010-9065-4.
PubMed 21063498van den Brand JG, Nelson T, Verleisdonk EJ, van der Werken C. The diagnostic value of intracompartmental pressure measurement, magnetic resonance imaging, and near-infrared spectroscopy in chronic exertional compartment syndrome: a prospective study in 50 patients. Am J Sports Med. 2005 May;33(5):699-704. doi: 10.1177/0363546504270565. Epub 2005 Feb 16.
PubMed 15722275
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT03736174
- Acronym / sponsor ID
- 18-1297
- Conditions
- Chronic Exertional Compartment Syndrome
- Keywords
- CECS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate high frequency ultrasound as a future modality for the diagnosis of chronic exertional compartment syndrome (CECS). The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS.
Detailed description
The purpose of this study is to investigate high frequency ultrasound as a future modality for the diagnosis of chronic exertional compartment syndrome (CECS). The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compartment thickness at its largest dimension. A specific aim for this study would be to facilitate future research in order to eliminate the need for painful and invasive diagnostic techniques for CECS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compartment Pressure Testing | – | –Patients who present with symptoms of CECS will be consented and tested per protocol with compartment pressure testing. Concurrently, patients will undergo a high frequency ultrasound to observe any patterns in structure to assist future research in noninvasively diagnosing CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compartment thickness at its largest dimension. |
| Control | – | –Control subjects will undergo exercise protocol and ultrasound, but will not have compartment pressure testing completed. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are seen at the University of Colorado Sports Medicine Clinic who present with symptoms of CECS.
Key inclusion criteria (7 listed)
- Male or female ages 13 and over
- Patients with any combination of the following symptoms who would otherwise be evaluated for CECS:
- Symptoms of leg pain worsened with activity and relieved by rest
- Pain that is generalized in the anterior or lateral compartments of lower leg
- Numbness or tingling in the distribution of the superficial peroneal nerve
Key exclusion criteria (2 listed)
- Known vascular disease
- Neurogenic or radicular symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ultrasound to predict/diagnose CECS
Time frame: 2 weeks
Determine if there are significant radiologic patterns arising on ultrasound imaging to help further future research predict or diagnose CECS using non-invasive methods.Specific aim is to investigate high frequency ultrasound as a future modality for the diagnosis of CECS. The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 22627653Aweid O, Del Buono A, Malliaras P, Iqbal H, Morrissey D, Maffulli N, Padhiar N. Systematic review and recommendations for intracompartmental pressure monitoring in diagnosing chronic exertional compartment syndrome of the leg. Clin J Sport Med. 2012 Jul;22(4):356-70. doi: 10.1097/JSM.0b013e3182580e1d.
- Background: PubMed 9132204Barnes M. Diagnosis and management of chronic compartment syndromes: a review of the literature. Br J Sports Med. 1997 Mar;31(1):21-7. doi: 10.1136/bjsm.31.1.21. No abstract available.
- Background: PubMed 12889865Fraipont MJ, Adamson GJ. Chronic exertional compartment syndrome. J Am Acad Orthop Surg. 2003 Jul-Aug;11(4):268-76. doi: 10.5435/00124635-200307000-00006.
- Background: PubMed 7094462Gershuni DH, Gosink BB, Hargens AR, Gould RN, Forsythe JR, Mubarak SJ, Akeson WH. Ultrasound evaluation of the anterior musculofascial compartment of the leg following exercise. Clin Orthop Relat Res. 1982 Jul;(167):185-90.
- Background: PubMed 15005334Lynch JE, Heyman JS, Hargens AR. Ultrasonic device for the noninvasive diagnosis of compartment syndrome. Physiol Meas. 2004 Feb;25(1):N1-9. doi: 10.1088/0967-3334/25/1/n01.
- Background: PubMed 23321416Paik RS, Pepple DA, Hutchinson MR. Chronic exertional compartment syndrome. BMJ. 2013 Jan 15;346:f33. doi: 10.1136/bmj.f33. No abstract available.
- Background: PubMed 2301689Pedowitz RA, Hargens AR, Mubarak SJ, Gershuni DH. Modified criteria for the objective diagnosis of chronic compartment syndrome of the leg. Am J Sports Med. 1990 Jan-Feb;18(1):35-40. doi: 10.1177/036354659001800106.
- Background: PubMed 23558330Rajasekaran S, Beavis C, Aly AR, Leswick D. The utility of ultrasound in detecting anterior compartment thickness changes in chronic exertional compartment syndrome: a pilot study. Clin J Sport Med. 2013 Jul;23(4):305-11. doi: 10.1097/JSM.0b013e3182856046.
- Background: PubMed 22092446Roberts A, Franklyn-Miller A. The validity of the diagnostic criteria used in chronic exertional compartment syndrome: a systematic review. Scand J Med Sci Sports. 2012 Oct;22(5):585-95. doi: 10.1111/j.1600-0838.2011.01386.x. Epub 2011 Sep 13.
- Background: PubMed 25406302Roscoe D, Roberts AJ, Hulse D. Intramuscular compartment pressure measurement in chronic exertional compartment syndrome: new and improved diagnostic criteria. Am J Sports Med. 2015 Feb;43(2):392-8. doi: 10.1177/0363546514555970. Epub 2014 Nov 18.
- Background: PubMed 21063498Tucker AK. Chronic exertional compartment syndrome of the leg. Curr Rev Musculoskelet Med. 2010 Sep 2;3(1-4):32-7. doi: 10.1007/s12178-010-9065-4.
- Background: PubMed 15722275van den Brand JG, Nelson T, Verleisdonk EJ, van der Werken C. The diagnostic value of intracompartmental pressure measurement, magnetic resonance imaging, and near-infrared spectroscopy in chronic exertional compartment syndrome: a prospective study in 50 patients. Am J Sports Med. 2005 May;33(5):699-704. doi: 10.1177/0363546504270565. Epub 2005 Feb 16.
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.
Michelle Wolcott, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Exertional Compartment Syndrome, run by University of Colorado, Denver 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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.
Are results available for this study?
Results are not available in the source record.
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?
Ultrasound to predict/diagnose CECS (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736174, which also lists 12 linked publications.
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 25 Apr 2023.