NCT04619849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

November 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 3, 2020

Last Update Submit

November 5, 2020

Conditions

Keywords

carpal tunnel syndromepalmaris longusmedian nervecarpal tunnel

Outcome Measures

Primary Outcomes (2)

  • Median Nerve Conduction Velocity

    right and left median nerve conduction velocity will be assessed with EMG, (m/s)

    1st day

  • Median Nerve Peak Latency

    right and left median nerve peak latency will be assessed with EMG,0 (ms)

    1st day

Secondary Outcomes (2)

  • Ulnar Nerve Conduction Velocity

    1st day

  • Ulnar Nerve Peak Latency

    1st day

Study Arms (1)

palmaris longus and carpal tunnel

EXPERIMENTAL

EMG measurements of median and ulnar nerves will be made in patients with palmaris longus muscle.

Diagnostic Test: EMGDiagnostic Test: Palmaris Longus Test

Interventions

EMGDIAGNOSTIC_TEST

Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.

palmaris longus and carpal tunnel
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.

palmaris longus and carpal tunnel

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Applying to the electrophysiology laboratory for an EMG examination for entrapment neuropathy. The examination should be requested by a doctor.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeBeckwith-Wiedemann SyndromeMedian Neuropathy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting Disorders

Study Officials

  • Mustafa Şahin, PhD

    Medipol University

    STUDY CHAIR

Central Study Contacts

Gizem Ergezen, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gizem Ergezen, MSc, Physiotherapist

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 6, 2020

Study Start

November 5, 2020

Primary Completion

December 19, 2020

Study Completion

December 31, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations