NCT04967144

Brief Summary

The discrimination of the right/left side of the body is related to the integrity of the motor and somatosensory areas at the cortical and subcortical levels. Although some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect has not been proven in milder neuropathies. In this study, the effect on right/left side discrimination will be investigated even in cases with carpal tunnel syndrome. Additionally, the investigators aimed to assess the relationship between right/left discrimination and symptom severity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 19, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

July 8, 2021

Last Update Submit

February 21, 2022

Conditions

Keywords

Carpal tunnel syndrome, body schema

Outcome Measures

Primary Outcomes (1)

  • Left/right judgement Task

    The Recognize tablet application will be used within the scope of the 'Graded Motor Imagery' set, in the series of publications created by www.noigroup.com right/left side judgement. The application will be performed on a single tablet screen. Within the scope of the application, right and left-hand pictures will be shown to the participants in varying positions and angles at 5-second intervals. The test consists of 50 pictures. At the end of the test, the accuracy rate and the average reaction time will be calculated separately for the right and left sides.

    3 months

Secondary Outcomes (5)

  • Handgrip strength

    3 months

  • Two-point discrimination test

    3 months

  • Visual Analogue Scale

    3 months

  • PainDETECT questionnaire

    3 months

  • Boston Carpal Tunnel Questionnaire

    3 months

Study Arms (2)

Carpal Tunnel syndrome

.Patients with carpal tunnel syndrome

Diagnostic Test: Nerve conduction studyDiagnostic Test: Montreal Cognitive Assessment Test

Control subjects

Healthy subjects

Diagnostic Test: Nerve conduction studyDiagnostic Test: Montreal Cognitive Assessment Test

Interventions

Nerve conduction studyDIAGNOSTIC_TEST

Participants with carpal tunnel syndrome will consist of individuals whose diagnosis has been confirmed by an electrophysiological study. Participants in the control group will consist of those who have been confirmed not to have carpal tunnel syndrome by nerve conduction study.

Carpal Tunnel syndromeControl subjects

Montreal Cognitive Assessment Test evaluates eight separate cognitive functions. Thirty is the highest score. The scores equal to or above 26 are considered normal cognitive function.

Carpal Tunnel syndromeControl subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Carpal Tunnel Syndrome

You may qualify if:

  • Participants with a duration of symptoms associated with unilateral CTS of at least 3 months
  • Participants with clinically and nerve conduction study confirmed carpal tunnel syndrome
  • All participants will be right-hand dominance and diagnosed with carpal tunnel syndrome on the same side
  • Participants with MOCA score minimum 26.

You may not qualify if:

  • Severe visual impairment that may prevent performing the test
  • Polyneuropathy
  • Cervical spine surgery history
  • Presence of abnormal cervical spine, shoulder, and elbow joint examination findings
  • Patients with any history of surgery for the upper extremity
  • Congenital/Developmental upper extremity malformations
  • Central nervous system disease
  • Antihistaminic, gabapentinoids, antiepileptics, methylphenidate, modafinil, neuroleptics use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Izmir Bozyaka Training and Research Hospital

Izmir, Karabaglar, Turkey (Türkiye)

Location

Related Publications (5)

  • Breckenridge JD, Ginn KA, Wallwork SB, McAuley JH. Do People With Chronic Musculoskeletal Pain Have Impaired Motor Imagery? A Meta-analytical Systematic Review of the Left/Right Judgment Task. J Pain. 2019 Feb;20(2):119-132. doi: 10.1016/j.jpain.2018.07.004. Epub 2018 Aug 9.

    PMID: 30098404BACKGROUND
  • Schmid AB, Coppieters MW. Left/right judgment of body parts is selectively impaired in patients with unilateral carpal tunnel syndrome. Clin J Pain. 2012 Sep;28(7):615-22. doi: 10.1097/AJP.0b013e31823e16b9.

  • Moseley GL. Why do people with complex regional pain syndrome take longer to recognize their affected hand? Neurology. 2004 Jun 22;62(12):2182-6. doi: 10.1212/01.wnl.0000130156.05828.43.

  • Williams LJ, Braithwaite FA, Leake HB, McDonnell MN, Peto DK, Lorimer Moseley G, Hillier SL. Reliability and validity of a mobile tablet for assessing left/right judgements. Musculoskelet Sci Pract. 2019 Apr;40:45-52. doi: 10.1016/j.msksp.2019.01.010. Epub 2019 Jan 24.

  • Akcay S, Koskderelioglu A, Ince B, Elif Saka F, Eskut N, Goksel Karatepe A. Is the left/right judgment task performance altered in unilateral carpal tunnel syndrome: And associated with symptom severity? Musculoskelet Sci Pract. 2022 Dec;62:102641. doi: 10.1016/j.msksp.2022.102641. Epub 2022 Aug 4.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Seniz Akcay, Assoc Prof

    University of Health Sciences Izmir Bozyaka Training and Research Hospital

    STUDY DIRECTOR
  • Altinay Goksel Karatepe, Prof

    University of Health Sciences Izmir Bozyaka Training and Research Hospital

    STUDY CHAIR
  • Fikriye Elif Saka, MD

    University of Health Sciences Izmir Bozyaka Training and Research Hospital

    STUDY CHAIR
  • Asli Koskderelioglu, Assoc Prof

    University of Health Sciences Izmir Bozyaka Training and Research Hospital

    STUDY CHAIR
  • Neslihan Eskut, Specialist

    University of Health Sciences Izmir Bozyaka Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 19, 2021

Study Start

July 19, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

The clinical study report will be shared at the end of the study.

Locations