Clinical trial NCT05927896: Reliability and Validity of the Turkish Version of the 6-item Carpal Tunnel Syndrome Symptoms Scale
Official title: Reliability and Validity of the Turkish Version of the 6-item Carpal Tunnel Syndrome Symptoms Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Symptoms and Signs
Keywords: carpal tunnel syndrome
Boston Carpal Tunnel Questionnaire
validity
Turkish adaptation
reliability
6-item Carpal Tunnel Syndrome Symptoms Scale
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 60 Carpal Tunnel Syndrome patients

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6-item CTS Symptom Scale (CTS-6)
timeFrame: baseline
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: baseline
measure: The Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Kestel State Hospital
Study officials:
affiliation: Balikesir University
name: Ender Salbaş, MD
role: STUDY_DIRECTOR
References:
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