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

NCT05927896 | Completed

• 1 other identifier: 9999999991
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 6-item CTS Symptom Scale (CTS-6)

  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)

  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)

  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

Interventions

6-item Carpal Tunnel Syndrome Symptoms Scale DIAGNOSTIC_TEST

6-item Carpal Tunnel Syndrome Symptoms Scale is a self-reported 6 item questionnaire.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 Carpal Tunnel Syndrome patients

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa Kestel State Hospital

Bursa, Turkey (Türkiye)

Location

Related Publications (10)

• Sevy JO, Sina RE, Varacallo MA. Carpal Tunnel Syndrome. 2023 Oct 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448179/

  PMID: 28846321 BACKGROUND

• Hoang-Kim A, Pegreffi F, Moroni A, Ladd A. Measuring wrist and hand function: common scales and checklists. Injury. 2011 Mar;42(3):253-8. doi: 10.1016/j.injury.2010.11.050. Epub 2010 Dec 15.

  PMID: 21159335 BACKGROUND

• Chung KC, Pillsbury MS, Walters MR, Hayward RA. Reliability and validity testing of the Michigan Hand Outcomes Questionnaire. J Hand Surg Am. 1998 Jul;23(4):575-87. doi: 10.1016/S0363-5023(98)80042-7.

  PMID: 9708370 BACKGROUND

• Schulze DG, Nilsen KB, Killingmo RM, Zwart JA, Grotle M. Clinical Utility of the 6-Item CTS, Boston-CTS, and Hand-Diagram for Carpal Tunnel Syndrome. Front Neurol. 2021 Jul 27;12:683807. doi: 10.3389/fneur.2021.683807. eCollection 2021.

  PMID: 34385969 BACKGROUND

• Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.

  PMID: 8245050 BACKGROUND

• Atroshi I, Lyren PE, Ornstein E, Gummesson C. The six-item CTS symptoms scale and palmar pain scale in carpal tunnel syndrome. J Hand Surg Am. 2011 May;36(5):788-94. doi: 10.1016/j.jhsa.2011.02.021.

  PMID: 21527135 BACKGROUND

• Atroshi I, Lyren PE, Gummesson C. The 6-item CTS symptoms scale: a brief outcomes measure for carpal tunnel syndrome. Qual Life Res. 2009 Apr;18(3):347-58. doi: 10.1007/s11136-009-9449-3. Epub 2009 Feb 20.

  PMID: 19229657 BACKGROUND

• Mollestam K, Rosales RS, Lyren PE, Atroshi I. Measuring symptoms severity in carpal tunnel syndrome: score agreement and responsiveness of the Atroshi-Lyren 6-item symptoms scale and the Boston symptom severity scale. Qual Life Res. 2022 May;31(5):1553-1560. doi: 10.1007/s11136-021-03039-1. Epub 2021 Nov 20.

  PMID: 34800220 BACKGROUND

• Lyren PE, Atroshi I. Using item response theory improved responsiveness of patient-reported outcomes measures in carpal tunnel syndrome. J Clin Epidemiol. 2012 Mar;65(3):325-34. doi: 10.1016/j.jclinepi.2011.08.009. Epub 2011 Dec 15.

  PMID: 22172153 BACKGROUND

• Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.

  PMID: 20874835 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Signs and Symptoms

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Pathological Conditions, Signs and Symptoms

Study Officials

• Ender Salbaş, MD

  Balikesir University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; Physical Medicine & Rehabilitation Specialist Physician

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: April 30, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: July 5, 2023

Record last verified: 2023-07

Locations

TU (1)