Carpal Tunnel Syndrome, Right/Left Judgement

February 21, 2022 updated by: Şeniz Akçay, Bozyaka Training and Research Hospital

Right/Left Judgement in Carpal Tunnel Syndrome

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.

Study Overview

Detailed Description

The left/right discrimination is a motor imagery task that involves viewing images of a body part and determining whether each image belongs to the left or right side of the body or if it rotates towards it. 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, such as carpal tunnel syndrome. In this study, the relationship between right/left decision accuracy will be compared with control subjects. The investigators will assess the relationship between right/left judgment and symptom severity, two-point discrimination, and handgrip force.

The hypothesis of the study are:

  1. The right/left discrimination accuracy is less than the control subjects.
  2. Right/left discrimination is in relationship with symptom severity, two-point discrimination, and handgrip force.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Karabaglar
      • Izmir, Karabaglar, Turkey
        • University of Health Sciences Izmir Bozyaka Training and Research Hospital

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Carpal Tunnel Syndrome

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Carpal Tunnel syndrome
.Patients with carpal tunnel syndrome

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.

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.
Control subjects
Healthy subjects

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left/right judgement Task
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: 3 months
The both handgrip strength of the participants will be evaluated with a JAMAR hand dynamometer.
3 months
Two-point discrimination test
Time Frame: 3 months
The participants will use a 2-point disc-criminator with 2-point separation and the narrowest interval reported by the participant as two separate points with repetitive measurements from the distal volar region of both index fingers will be recorded.
3 months
Visual Analogue Scale
Time Frame: 3 months
The patient will be asked to mark his/her severity of pain on a 10-cm horizontal line with number 0 one end representing 'no' and number 10 on the other end indicating 'very severe pain'.
3 months
PainDETECT questionnaire
Time Frame: 3 months
The presence of neuropathic pain will be evaluated with the painDETECT questionnaire. The maximum score is 35 and a high score indicates the severity of neuropathic pain. When the painDETECT questionnaire score is more than 13, it is indicated the presence of a neuropathic pain component.
3 months
Boston Carpal Tunnel Questionnaire
Time Frame: 3 months
The questionnaire comprises two parts, the Symptom Severity (SSS) and the Functional Status Scale (FSS). In the SSS, there are 11 questions; responses may be scored one (mildest) point to five (most severe) points. In the FSS, there are eight questions assessing the difficulty in performing selected activities.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

July 19, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

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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