- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04967144
Carpal Tunnel Syndrome, Right/Left Judgement
Right/Left Judgement in Carpal Tunnel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Karabaglar
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Izmir, Karabaglar, Turkey
- University of Health Sciences Izmir Bozyaka Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Carpal Tunnel syndrome
.Patients with carpal tunnel syndrome
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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.
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Control subjects
Healthy subjects
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Left/right judgement Task
Time Frame: 3 months
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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.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip strength
Time Frame: 3 months
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The both handgrip strength of the participants will be evaluated with a JAMAR hand dynamometer.
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3 months
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Two-point discrimination test
Time Frame: 3 months
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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.
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3 months
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Visual Analogue Scale
Time Frame: 3 months
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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'.
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3 months
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PainDETECT questionnaire
Time Frame: 3 months
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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.
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3 months
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Boston Carpal Tunnel Questionnaire
Time Frame: 3 months
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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.
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3 months
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Collaborators and Investigators
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
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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