Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome

NCT03736174 | Unknown

• 1 other identifier: 18-1297
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Exertional Compartment Syndrome

Keywords

CECS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Known vascular disease
• Neurogenic or radicular symptoms

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado - Sports Medicine

Denver, Colorado, 80222, United States

Location

Related 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.

  PMID: 22627653 BACKGROUND

• 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.

  PMID: 9132204 BACKGROUND

• 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.

  PMID: 12889865 BACKGROUND

• 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.

  PMID: 7094462 BACKGROUND

• 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.

  PMID: 15005334 BACKGROUND

• Paik RS, Pepple DA, Hutchinson MR. Chronic exertional compartment syndrome. BMJ. 2013 Jan 15;346:f33. doi: 10.1136/bmj.f33. No abstract available.

  PMID: 23321416 BACKGROUND

• 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.

  PMID: 2301689 BACKGROUND

• 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.

  PMID: 23558330 BACKGROUND

• 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.

  PMID: 22092446 BACKGROUND

• 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.

  PMID: 25406302 BACKGROUND

• 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.

  PMID: 21063498 BACKGROUND

• 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.

  PMID: 15722275 BACKGROUND

MeSH Terms

Conditions

Chronic Exertional Compartment Syndrome

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Wolcott, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 9, 2018
• Study Start: December 7, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

US (1)