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NCT Number: NCT04967144

Carpal Tunnel Syndrome, Right/Left Judgement

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences Izmir Bozyaka Training and Research Hospital

Izmir, Karabaglar, Turkey (Türkiye)

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nerve Conduction Study

Diagnostic 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.

Montreal Cognitive Assessment Test

Diagnostic Test

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Handgrip strength

    Time frame: 3 months

    The both handgrip strength of the participants will be evaluated with a JAMAR hand dynamometer.

  2. 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. 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'.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

Right/Left Judgement in Carpal Tunnel Syndrome

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2021
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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