Carpal Tunnel Syndrome, Right/Left Judgement

Carpal Tunnel Syndrome Clinical Trial

Official title:

Right/Left Judgement in Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967144
• Other study ID #: 2021/40
• Status: Completed
• Start date: July 19, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Nerve conduction study
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
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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences Izmir Bozyaka Training and Research Hospital	Izmir	Karabaglar

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Handgrip strength	The both handgrip strength of the participants will be evaluated with a JAMAR hand dynamometer.	3 months
Secondary	Two-point discrimination test	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
Secondary	Visual Analogue Scale	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
Secondary	PainDETECT questionnaire	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
Secondary	Boston Carpal Tunnel Questionnaire	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