Electrophysiological Changes Based on the Palmaris Longus

• ClinicalTrials.gov Identifier: NCT04619849
• Recruitment Status: Not yet recruiting
• First Posted: November 6, 2020
• Last Update Posted: November 6, 2020
• Sponsor: Istanbul Medipol University Hospital
• Information provided by (Responsible Party): gizem ergezen, Istanbul Medipol University Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Palmaris Longus Muscle, Absence of; Carpal Tunnel Syndrome; EMG Syndrome	Diagnostic Test: EMG; Diagnostic Test: Palmaris Longus Test	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Electrophysiological Changes in the Median Nerve in the Presence and Absence of the Palmaris Longus
• Estimated Study Start Date: November 5, 2020
• Estimated Primary Completion Date: December 19, 2020
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: palmaris longus and carpal tunnel; EMG measurements of median and ulnar nerves will be made in patients with palmaris longus muscle.	Diagnostic Test: EMG; Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.; Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures :

1. Median Nerve Conduction Velocity [ Time Frame: 1st day ]
   right and left median nerve conduction velocity will be assessed with EMG, (m/s)
2. Median Nerve Peak Latency [ Time Frame: 1st day ]
   right and left median nerve peak latency will be assessed with EMG,0 (ms)

Secondary Outcome Measures :

1. Ulnar Nerve Conduction Velocity [ Time Frame: 1st day ]
   right and left ulnar nerve conduction velocity will be assessed with EMG, (m/s)
2. Ulnar Nerve Peak Latency [ Time Frame: 1st day ]
   right and left ulnar nerve peak latency will be assessed with EMG,0 (ms)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Gizem Ergezen, MSc; +905347098414; gergezen@medipol.edu.tr

Locations

Turkey

Istanbul Medipol University

Istanbul, Beykoz, Turkey, 34815

Sponsors and Collaborators

Istanbul Medipol University Hospital

Investigators

• Study Chair: Mustafa Şahin, PhD; Medipol University

More Information

• Responsible Party: gizem ergezen, Gizem Ergezen, MSc, Physiotherapist, Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT04619849
• Other Study ID Numbers: 10840098-722.02-E.342196
• First Posted: November 6, 2020
• Last Update Posted: November 6, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by gizem ergezen, Istanbul Medipol University Hospital:

carpal tunnel syndrome; palmaris longus; median nerve; carpal tunnel

Additional relevant MeSH terms:

Carpal Tunnel Syndrome; Beckwith-Wiedemann Syndrome; Syndrome; Disease; Pathologic Processes; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn