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

Sponsor
Bursa City Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05927896
Collaborator
(none)
60
1
6
10

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 6-item Carpal Tunnel Syndrome Symptoms Scale

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Reliability and Validity of the Turkish Version of the 6-item Carpal Tunnel Syndrome Symptoms Scale
Actual Study Start Date :
Apr 30, 2021
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Oct 30, 2021

Outcome Measures

Primary Outcome Measures

  1. 6-item CTS Symptom Scale (CTS-6) [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.

  2. Boston Carpal Tunnel Questionnaire (BCTQ) [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.

  3. The Michigan Hand Outcomes Questionnaire (MHQ) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bursa Kestel State Hospital Bursa Turkey

Sponsors and Collaborators

  • Bursa City Hospital

Investigators

  • Study Director: Ender Salbaş, MD, Balikesir University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sezin Solum, MD; Physical Medicine & Rehabilitation Specialist Physician, Bursa City Hospital
ClinicalTrials.gov Identifier:
NCT05927896
Other Study ID Numbers:
  • 9999999991
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sezin Solum, MD; Physical Medicine & Rehabilitation Specialist Physician, Bursa City Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2023