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The Use of Ultrasound to Quantify Muscle Overlying the Carpal Tunnel

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ClinicalTrials.gov Identifier: NCT02683343
Recruitment Status : Withdrawn (PI is away, will hopefully perform the study at another institution.)
First Posted : February 17, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Clalit Health Services

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.


Condition or disease
Carpal Tunnel Syndrome

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Group/Cohort
carpal tunnel syndrome
No intervention
normals
no intervention



Primary Outcome Measures :
  1. amount-depth of muscle overlying the carpal tunnel [ Time Frame: 2 years ]
    As determined by ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with the diagnosis of CTS and those without
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
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Responsible Party: Clalit Health Services
ClinicalTrials.gov Identifier: NCT02683343    
Other Study ID Numbers: Muscle mass
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: July 2015
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries