Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome

Chronic Exertional Compartment Syndrome Clinical Trial

Official title:

The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03736174
• Other study ID #: 18-1297
• Status: Active, not recruiting
• Start date: December 7, 2018
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Exertional Compartment Syndrome
• Compartment Syndromes
• Syndrome

Locations

Country	Name	City	State
United States	University of Colorado - Sports Medicine	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

Barnes 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. — View Citation

Fraipont 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. — View Citation

Gershuni 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. — View Citation

Lynch 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. — View Citation

Paik RS, Pepple DA, Hutchinson MR. Chronic exertional compartment syndrome. BMJ. 2013 Jan 15;346:f33. doi: 10.1136/bmj.f33. No abstract available. Erratum In: BMJ. 2013;346:f544. Pepples, Douglas [corrected to Pepple, Douglas A]. — View Citation

Pedowitz 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. — View Citation

Rajasekaran 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. — View Citation

Roberts 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. — View Citation

Roscoe 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. — View Citation

Tucker 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. — View Citation

van 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks