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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04619849
Other study ID # 10840098-722.02-E.342196
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 5, 2020
Est. completion date December 31, 2020

Study information

Verified date November 2020
Source Istanbul Medipol University Hospital
Contact Gizem Ergezen, MSc
Phone +905347098414
Email gergezen@medipol.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

One of the most important causes of carpal tunnel syndrome is increased pressure in the canal. With the loading of the palmaris longus at 20 degrees of wrist extension, the pressure within the canal increases more than the load exerted on other flexor tendons. Several studies have shown the association of carpal tunnel syndrome with the presence of palmaris longus. In this study, our aim is to investigate how the presence or absence of palmaris longus changes EMG measurements in the median nerve. Individuals with a diagnosis of carpal tunnel syndrome or entrapment neuropathy will be given the Schaffer test, a standardized test to test the presence of the palmaris longus muscle. The result will be noted, EMG examination will be requested and the electrophysiological properties of the median nerve will be recorded.


Description:

One of the most important causes of carpal tunnel syndrome(CTS) is the pressure increase in the canal. With the loading of the palmaris longus at 20 degrees of wrist extension, the pressure within the canal increases more than the load exerted on other flexor tendons. Several studies have shown the association of carpal tunnel syndrome with the presence of palmaris longus. Our aim in this study is to investigate how the presence or absence of the palmaris longus changes the EMG measurements in the median nerve. Individuals with a diagnosis of carpal tunnel syndrome or entrapment neuropathy will be given the Schaffer test, a standardized test to test the presence of the palmaris longus muscle. The result will be noted, EMG examination will be requested, and the electrophysiological properties of the median nerve will be recorded. If the Schaffer test that detects the presence of palmaris longus is negative, 4 different tests that will prove the absence of palmaris longus will be performed by the same practitioner. These 4 tests are Thompson's test, Mishra's test I, Mishra's test II and Pushpakumar's "two-finger sign" method. Routine median nerve conduction studies are valuable in CTS. Prolonged distal latency in motor and sensory nerves can be found in most cases of CTS. If routine studies are insufficient, more sensitive methods are needed. These; Comparison of mixed latencies in the wrist recording of the sensory responses of the median and ulnar nerves with palmar stimulation, median and ulnar sensory latencies with orthodromic or antidromic recording from the 4th finger, median and ulnar motor latencies with recording from the second lumbrical and second interosseous muscle, median and radial sensory latencies with thumb recording It is based on determining the compression point by centrifugation method by performing segmental sensory nerve conduction examination.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2020
Est. primary completion date December 19, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - Applying to the electrophysiology laboratory for an EMG examination for entrapment neuropathy. The examination should be requested by a doctor. Exclusion Criteria: - Having a disease affecting the orthopedic, neurological or rheumatological skeletal and neurological system; - Those who do physical activity so heavy that they cause muscle pain or neurological damage; - Those who have an operation in the area to be evaluated

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
EMG
Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
Palmaris Longus Test
Schaffer test will be done to understand the presence of palmaris longus. 4 different tests will be done to prove its absence.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median Nerve Conduction Velocity right and left median nerve conduction velocity will be assessed with EMG, (m/s) 1st day
Primary Median Nerve Peak Latency right and left median nerve peak latency will be assessed with EMG,0 (ms) 1st day
Secondary Ulnar Nerve Conduction Velocity right and left ulnar nerve conduction velocity will be assessed with EMG, (m/s) 1st day
Secondary Ulnar Nerve Peak Latency right and left ulnar nerve peak latency will be assessed with EMG,0 (ms) 1st day
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