Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression

Carpal tunnel syndrome is caused by compression of the median nerve at the wrist. The hypothesis is that ultrasound imaging can be used to visualize nerve compression in carpal tunnel patients during hand activity, and normal subjects will not demonstrate any nerve compression.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome

Detailed Description

Two patients with carpal tunnel syndrome underwent nerve testing to document that they had median nerve abnormality at the wrist. They subsequently had ultrasound imaging of the wrist at rest and during a stress test using hand activity. Two control subjects had nerve testing to prove that they had no nerve abnormality at the carpal tunnel. The carpal tunnel syndrome patients demonstrated nerve compression on the ultrasound images during the stress tests and the normal subjects showed no nerve compression.

• Study Type: Observational
• Enrollment (Actual): 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with upper extremity symptoms of pain, numbness, and tingling; Adult subjects with no upper extremity pain, numbness, or tingling

Description

Inclusion Criteria:

• Patients must have symptoms consistent with carpal tunnel syndrome and electrodiagnostic testing that demonstrates abnormal median nerve function at the wrist, consistent with carpal tunnel syndrome.
• Normal subjects must have no upper limb symptoms to support carpal tunnel syndrome and normal nerve testing.

Exclusion Criteria:

• Patients excluded if nerve testing was not consistent with carpal tunnel syndrome.
• Normals excluded if nerve testing demonstrated any median nerve abnormality.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Carpal Tunnel patients; These patients have documented carpal tunnel syndrome
Normal Subjects; These individuals have no carpal tunnel syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median nerve compressive narrowing on ultrasound imaging in carpal tunnel syndrome patients	5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
No median nerve compressive narrowing in normal subjects	5 months

Collaborators and Investigators

• Sponsor: EMG Labs of Arizona Arthritis & Rheumatology Associates
• Investigators: Principal Investigator: Benjamin M Sucher, DO, EMG Labs of AARA

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 29, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (Estimate): October 1, 2009

Study Record Updates

• Last Update Posted (Estimate): October 1, 2009
• Last Update Submitted That Met QC Criteria: September 30, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; median nerve; ultrasound; electrodiagnosis; Normal subjects
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: CTS-US Med N JAOA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No