- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04619849
Electrophysiological Changes Based on the Palmaris Longus
November 5, 2020 updated by: gizem ergezen, Istanbul Medipol University Hospital
Electrophysiological Changes in the Median Nerve in the Presence and Absence of the Palmaris Longus
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gizem Ergezen, MSc
- Phone Number: +905347098414
- Email: gergezen@medipol.edu.tr
Study Locations
-
-
Beykoz
-
Istanbul, Beykoz, Turkey, 34815
- Istanbul Medipol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
Schaffer test will be done to understand the presence of palmaris longus.
4 different tests will be done to prove its absence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Nerve Conduction Velocity
Time Frame: 1st day
|
right and left median nerve conduction velocity will be assessed with EMG, (m/s)
|
1st day
|
Median Nerve Peak Latency
Time Frame: 1st day
|
right and left median nerve peak latency will be assessed with EMG,0 (ms)
|
1st day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ulnar Nerve Conduction Velocity
Time Frame: 1st day
|
right and left ulnar nerve conduction velocity will be assessed with EMG, (m/s)
|
1st day
|
Ulnar Nerve Peak Latency
Time Frame: 1st day
|
right and left ulnar nerve peak latency will be assessed with EMG,0 (ms)
|
1st day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Mustafa Sahin, PhD, Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 5, 2020
Primary Completion (Anticipated)
December 19, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
November 3, 2020
First Submitted That Met QC Criteria
November 5, 2020
First Posted (Actual)
November 6, 2020
Study Record Updates
Last Update Posted (Actual)
November 6, 2020
Last Update Submitted That Met QC Criteria
November 5, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Wounds and Injuries
- Disease
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Median Neuropathy
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Abnormalities, Multiple
- Chromosome Disorders
- Syndrome
- Carpal Tunnel Syndrome
- Beckwith-Wiedemann Syndrome
Other Study ID Numbers
- 10840098-722.02-E.342196
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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