Electrophysiological Changes Based on the Palmaris Longus
Primary Purpose
Palmaris Longus Muscle, Absence of, Carpal Tunnel Syndrome, EMG Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EMG
Palmaris Longus Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Palmaris Longus Muscle, Absence of focused on measuring carpal tunnel syndrome, palmaris longus, median nerve, carpal tunnel
Eligibility 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
Sites / Locations
- Istanbul Medipol University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
palmaris longus and carpal tunnel
Arm Description
EMG measurements of median and ulnar nerves will be made in patients with palmaris longus muscle.
Outcomes
Primary Outcome Measures
Median Nerve Conduction Velocity
right and left median nerve conduction velocity will be assessed with EMG, (m/s)
Median Nerve Peak Latency
right and left median nerve peak latency will be assessed with EMG,0 (ms)
Secondary Outcome Measures
Ulnar Nerve Conduction Velocity
right and left ulnar nerve conduction velocity will be assessed with EMG, (m/s)
Ulnar Nerve Peak Latency
right and left ulnar nerve peak latency will be assessed with EMG,0 (ms)
Full Information
NCT ID
NCT04619849
First Posted
November 3, 2020
Last Updated
November 5, 2020
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04619849
Brief Title
Electrophysiological Changes Based on the Palmaris Longus
Official Title
Electrophysiological Changes in the Median Nerve in the Presence and Absence of the Palmaris Longus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2020 (Anticipated)
Primary Completion Date
December 19, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmaris Longus Muscle, Absence of, Carpal Tunnel Syndrome, EMG Syndrome
Keywords
carpal tunnel syndrome, palmaris longus, median nerve, carpal tunnel
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
palmaris longus and carpal tunnel
Arm Type
Experimental
Arm Description
EMG measurements of median and ulnar nerves will be made in patients with palmaris longus muscle.
Intervention Type
Diagnostic Test
Intervention Name(s)
EMG
Intervention Description
Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
Intervention Type
Diagnostic Test
Intervention Name(s)
Palmaris Longus Test
Intervention Description
Schaffer test will be done to understand the presence of palmaris longus. 4 different tests will be done to prove its absence.
Primary Outcome Measure Information:
Title
Median Nerve Conduction Velocity
Description
right and left median nerve conduction velocity will be assessed with EMG, (m/s)
Time Frame
1st day
Title
Median Nerve Peak Latency
Description
right and left median nerve peak latency will be assessed with EMG,0 (ms)
Time Frame
1st day
Secondary Outcome Measure Information:
Title
Ulnar Nerve Conduction Velocity
Description
right and left ulnar nerve conduction velocity will be assessed with EMG, (m/s)
Time Frame
1st day
Title
Ulnar Nerve Peak Latency
Description
right and left ulnar nerve peak latency will be assessed with EMG,0 (ms)
Time Frame
1st day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gizem Ergezen, MSc
Phone
+905347098414
Email
gergezen@medipol.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Şahin, PhD
Organizational Affiliation
Medipol University
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34815
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Electrophysiological Changes Based on the Palmaris Longus
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