Reliability and Validity of the Turkish Version of the 6-item Carpal Tunnel Syndrome Symptoms Scale

July 1, 2023 updated by: Sezin Solum, Bursa City Hospital

Carpal tunnel syndrome (CTS) is a common condition that affects the median nerve that usually cause numbness, tingling, pain, and weakness in the hand and fingers. While definitive diagnosis is made with nerve conduction studies, the patient's history and physical examination findings lead the clinician to the diagnosis of CTS. Using factor analysis and item response theory methodology, Atroshi et al. developed a short 6-item version of the symptom severity scale to ease respondent burden while maintaining the psychometric properties of the Boston Carpal Tunnel Questionnaire. It has been demonstrated that the 6-item CTS Symptom Scale has good reliability, validity and responsiveness.

The aim of this study was to evaluate the reliability and construct validity of the Turkish version of the 6-item CTS symptoms scale for CTS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Carpal tunnel syndrome (CTS) is a common condition that affects the median nerve that usually cause numbness, tingling, pain, and weakness in the hand and fingers. While definitive diagnosis is made with nerve conduction studies, the patient's history and physical examination findings lead the clinician to the diagnosis of CTS. The use of patient-completed disease-specific scales is increasing in clinical research and patient follow-up. Various scales have been developed to question symptoms related to hand problems. The Boston Carpal Tunnel Questionnaire and the 6-item CTS Symptom Scale are the scales that have been shown to be used to assess symptom severity and for diagnostic screening. Using factor analysis and item response theory methodology, Atroshi et al. developed a short 6-item version of the symptom severity scale to ease respondent burden while maintaining the psychometric properties of the Boston Carpal Tunnel Questionnaire . It has been demonstrated that the 6-item CTS Symptom Scale has good reliability, validity and responsiveness.

The aim of this study was to evaluate the reliability and construct validity of the Turkish version of the 6-item CTS symptoms scale for CTS.

Study Type

Observational

Enrollment (Actual)

60

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

  • Turkey
      • Bursa, Turkey
        • Bursa Kestel State Hospital

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
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

60 Carpal Tunnel Syndrome patients

Description

Inclusion Criteria:

  • presence of numbness or tingling in at least two radial side fingers,
  • a positive Phalen's test result,
  • symptoms lasting more than three months
  • consistent nerve conduction study with CTS.

Exclusion Criteria:

  • those with no electrophysiological evidence of CTS,
  • diabetes or other metabolic diseases,
  • any other inflammatory diseases.

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
6-item CTS Symptom Scale (CTS-6)
Time Frame: baseline
The CTS-6 is a scale designed to measure the severity of CTS symptoms. It consists of six items, five of which are similar to those on the symptom severity subscale of the Boston CTS Scale, while the sixth item is a combination of two items from the same subscale.
baseline
Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: baseline
The BCTQ consists of two subscales, the Symptom Severity Scale and the Functional Status Scale. The Functional Status Scale contains eight items assessing activities such as "writing, buttoning clothes, holding a book while reading, grasping a telephone handle, opening a jar, doing housework, carrying grocery bags, bathing and dressing" whereas the 11-item Symptom Severity Scale assesses pain, paresthesia, numbness, weakness, nocturnal symptoms and grip difficulty.
baseline
The Michigan Hand Outcomes Questionnaire (MHQ)
Time Frame: baseline
MHQ is a standardized instrument designed to quantify outcomes in patients with a range of hand conditions. The MHQ consists of 6 subscales: hand function, activities of daily living, pain, satisfaction, aesthetics and work performance. A cumulative score is calculated to provide an indication of overall function.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Investigators

  • Study Director: Ender Salbaş, MD, Balikesir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 30, 2021

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9999999991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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