Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome

April 24, 2023 updated by: University of Colorado, Denver

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80222
        • University of Colorado - Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are seen at the University of Colorado Sports Medicine Clinic who present with symptoms of CECS.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Known vascular disease
  • Neurogenic or radicular symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1297

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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