- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05983614
Effects of Body Structures and Function on Actıvıty and Partıcıpatıon in Patıents wıth Carpal Tunnel Syndrome
May 20, 2025 updated by: Emrah Afsar, Kutahya Health Sciences University
Investigation of the Effects of Pain, Proprioception and Electrodiagnostic Findings on Activity and Participation in Patients With Idiopathic Carpal Tunnel Syndrome
The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS; to examine its effects on activity and participation.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
50
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
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-
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Kutahya, Turkey
- Kutahya Health Science University
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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
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients who applied to the Physical Therapy Department of Kutahya Health Sciences University Hospital and were diagnosed with mild and moderate CTS according to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) will be invited to the study.
Description
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 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Leeds Assessment Neuropathic Symptoms and Signs (LANSS)
Time Frame: 7 minutes
|
Leeds Assessment Neuropathic Symptoms and Signs (LANSS) scale is a clinical-based tool for identifying pain and patients with predominant neuropathic mechanisms.
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7 minutes
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Boston Carpal Tunnel Questionnaire
Time Frame: 12 minutes
|
It is a questionnaire used to evaluate symptom severity and functional status in individuals with carpal tunnel syndrome.
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12 minutes
|
|
Q-DASH
Time Frame: 10 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proprioception Assessment
Time Frame: 7 minutes
|
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
|
|
Visual Analog Scale
Time Frame: 2 minutes
|
Evaluates the severity of pain, scoring between 0-10.
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Emrah Afsar, Phd, Kutahya Health Sciences University
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)
August 5, 2023
Primary Completion (Actual)
October 15, 2023
Study Completion (Actual)
December 15, 2024
Study Registration Dates
First Submitted
August 1, 2023
First Submitted That Met QC Criteria
August 1, 2023
First Posted (Actual)
August 9, 2023
Study Record Updates
Last Update Posted (Actual)
May 23, 2025
Last Update Submitted That Met QC Criteria
May 20, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/16-2
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.