Clinical trial NCT03736174: Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome
Official title: The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Exertional Compartment Syndrome
Keywords: CECS
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasound to predict/diagnose CECS
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado - Sports Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Michelle Wolcott, MD
role: PRINCIPAL_INVESTIGATOR
References:
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