Palmaris Longus Muscle, Absence ofNCT04619849
Electrophysiological Changes Based on the Palmaris Longus
A study testing EMG and Palmaris Longus Test in people with Palmaris Longus Muscle, Absence of and Carpal Tunnel Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Palmaris Longus Muscle, Absence of, Carpal Tunnel Syndrome, EMG Syndrome
- What is being tested?
- EMG and Palmaris Longus Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Applying to the electrophysiology laboratory for an EMG examination for entrapment neuropathy. The examination should be requested by a doctor.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34815
About this study
Official title: 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.
Read the 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.
- Being tested
- EMG, Palmaris Longus Test
- Keywords
- carpal tunnel syndrome, palmaris longus, median nerve, carpal tunnel
- Medical subject headings
- Carpal Tunnel Syndrome, Beckwith-Wiedemann Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMGDiagnostic test
Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
Palmaris Longus TestDiagnostic test
Schaffer test will be done to understand the presence of palmaris longus. 4 different tests will be done to prove its absence.
| Study group | Role | What they receive |
|---|---|---|
| palmaris longus and carpal tunnel | Experimental | EMG measurements of median and ulnar nerves will be made in patients with palmaris longus muscle. Receives: Diagnostic Test: EMG; Diagnostic Test: Palmaris Longus Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Nerve Conduction Velocity
right and left median nerve conduction velocity will be assessed with EMG, (m/s)
Measured: 1st day
Median Nerve Peak Latency
right and left median nerve peak latency will be assessed with EMG,0 (ms)
Measured: 1st day
Secondary outcomes (2)
Ulnar Nerve Conduction Velocity
right and left ulnar nerve conduction velocity will be assessed with EMG, (m/s)
Measured: 1st day
Ulnar Nerve Peak Latency
right and left ulnar nerve peak latency will be assessed with EMG,0 (ms)
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start5 Nov 2020 (estimated)
- Primary completion19 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmaris Longus Muscle, Absence ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem ergezen, Istanbul Medipol University Hospital
- Investigators
- Mustafa Şahin, PhD, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619849
- Sponsor's protocol ID
- 10840098-722.02-E.342196
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Changes in the Median Nerve in the Presence and Absence of the Palmaris Longus
- ClinicalTrials.gov ID
- NCT04619849
- Acronym / sponsor ID
- 10840098-722.02-E.342196
- Keywords
- carpal tunnel syndrome, palmaris longus, median nerve, carpal tunnel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 5 Nov 2020 (estimated)
- Primary completion
- 19 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| palmaris longus and carpal tunnel | Experimental | Diagnostic Test: EMG, Diagnostic Test: Palmaris Longus TestEMG measurements of median and ulnar nerves will be made in patients with palmaris longus muscle. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Applying to the electrophysiology laboratory for an EMG examination for entrapment neuropathy. The examination should be requested by a doctor.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMGElectromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles. | Diagnostic test | palmaris longus and carpal tunnel |
| Palmaris Longus TestSchaffer test will be done to understand the presence of palmaris longus. 4 different tests will be done to prove its absence. | Diagnostic test | palmaris longus and carpal tunnel |
Primary outcome
Median Nerve Conduction Velocity
Time frame: 1st day
right and left median nerve conduction velocity will be assessed with EMG, (m/s)
Median Nerve Peak Latency
Time frame: 1st day
right and left median nerve peak latency will be assessed with EMG,0 (ms)
2 secondary outcomes
Ulnar Nerve Conduction Velocity
Time frame: 1st day
Ulnar Nerve Peak Latency
Time frame: 1st day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Şahin, PhD study chair
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG and Palmaris Longus Test in people with Palmaris Longus Muscle, Absence of and Carpal Tunnel Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gizem Ergezen, MSc (+905347098414, gergezen@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Nerve Conduction Velocity (time frame: 1st day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.