The Use of Ultrasound to Quantify Muscle Overlying the Carpal Tunnel

NCT02683343 | Withdrawn

• 1 other identifier: Muscle mass
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Carpal tunnel syndrome (CTS) is a common condition that still lacks a reliable, objective screening test. Many anatomical aspects of the syndrome have been studied including the dimensions of the carpal tunnel and shape of the nerve within the tunnel. The investigators have observed varying amounts of muscle overlying the carpal tunnel in patients undergoing surgery for the condition. Assuming that this muscle may have a dynamic role in the development of the condition, the investigators attempted to quantify this muscle using ultrasound (US). The purpose of this study was to devise a technique to evaluate the amount of muscle overlying the carpal tunnel. The hypothesis is that patients with carpal tunnel syndrome will have significantly more muscle overlying the carpal tunnel than individuals without carpal tunnel syndrome.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• amount-depth of muscle overlying the carpal tunnel

  As determined by ultrasound

  2 years

Study Arms (2)

carpal tunnel syndrome

No intervention

normals

no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis of CTS and those without

You may qualify if:

• The diagnosis of CTS will include signs and symptoms of CTS: nighttime numbness and tingling or numbness and tingling in a median nerve distribution with a positive phalen or tinel or forearm compression test as well as a nerve conduction test and electromyography (NCT and EMG) that is positive for CTS.
• The normal subjects: individuals that do not have any signs and or symptoms of CTS.

You may not qualify if:

• Patients or individuals that have a known history of peripheral neuropathy or other condition in the hand including recent significant trauma.
• Patients with incomplete or unclear evaluation and tests.
• Individuals unwilling to sign a consent form to participate in the study.

Sponsors & Collaborators

• Clalit Health Services: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: August 16, 2015
• First Posted: February 17, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 25, 2018

Record last verified: 2015-07