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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05983614
Other study ID # 2022/16-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 5, 2023
Est. completion date November 10, 2023

Study information

Verified date February 2024
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS; to examine its effects on activity and participation.


Description:

50 patients aged 20-55 years diagnosed with mild and moderate carpal tunnel syndrome according to AANEM will be included. VAS, LANSS, Boston Carpal Tunnel Questionnaire (Symptom Severity Scale - Functional Status Scale), Q-DASH, hand grip sensitivity measurement, hand pressure sensitivity measurement will be applied to the participants. In order to examine the relationship between body structure and functions (Pain, Sensation, EMG findings) and activity and participation with the AMOS program, the maximum likelihood method will be selected and a structural equation model (SEM) will be established.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 10, 2023
Est. primary completion date October 15, 2023
Accepts healthy volunteers
Gender All
Age group 25 Years to 55 Years
Eligibility Inclusion Criteria: - Being diagnosed with mild-moderate CTS - Being between the ages of 20-55 - Volunteering to participate in the study Exclusion Criteria: - Being diagnosed with severe CTS - Have systemic inflammatory disease - Having a disease that can cause polyneuropathy, such as diabetes mellitus - Being receiving psychotherapy - Illiteracy - Have a hearing problem - Have cognitive impairment - Having a pacemaker

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Kutahya Health Science University Kutahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Leeds Assessment Neuropathic Symptoms and Signs (LANSS) Leeds Assessment Neuropathic Symptoms and Signs (LANSS) scale is a clinical-based tool for identifying pain and patients with predominant neuropathic mechanisms. 7 minutes
Primary Boston Carpal Tunnel Questionnaire It is a questionnaire used to evaluate symptom severity and functional status in individuals with carpal tunnel syndrome. 12 minutes
Primary Q-DASH Q-DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. 10 minutes
Secondary Proprioception Assessment Hand grip sensitivity will be measured with a dynamometer and hand pressure sensitivity will be measured with a Stabilizer Pressure Biofeedback (SBP) instrument. 7 minutes
Secondary Visual Analog Scale Evaluates the severity of pain, scoring between 0-10. 2 minutes
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