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

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ClinicalTrials.gov Identifier: NCT05927896
Recruitment Status : Completed
First Posted : July 3, 2023
Last Update Posted : July 5, 2023
Sponsor:
Information provided by (Responsible Party):
Sezin Solum, Bursa City Hospital

Study Description
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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
Carpal Tunnel Syndrome Symptoms and Signs 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
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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 : April 30, 2021
Actual Primary Completion Date : October 30, 2021
Actual Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: 6-item Carpal Tunnel Syndrome Symptoms Scale
    6-item Carpal Tunnel Syndrome Symptoms Scale is a self-reported 6 item questionnaire.

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
60 Carpal Tunnel Syndrome patients
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05927896


Locations
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Turkey
Bursa Kestel State Hospital
Bursa, Turkey
Sponsors and Collaborators
Bursa City Hospital
Investigators
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Study Director: Ender Salbaş, MD Balikesir University
More Information
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Publications:

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Responsible Party: Sezin Solum, MD; Physical Medicine & Rehabilitation Specialist Physician, Bursa City Hospital
ClinicalTrials.gov Identifier: NCT05927896    
Other Study ID Numbers: 9999999991
First Posted: July 3, 2023    Key Record Dates
Last Update Posted: July 5, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sezin Solum, Bursa City Hospital:
carpal tunnel syndrome
Boston Carpal Tunnel Questionnaire
validity
 Turkish adaptation
reliability
6-item Carpal Tunnel Syndrome Symptoms Scale
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries