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Carpal Tunnel SyndromeNCT05927896

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

An observational study of Carpal Tunnel Syndrome and Symptoms and Signs, run by Bursa City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carpal Tunnel Syndrome, Symptoms and Signs
What is being tested?
6-item Carpal Tunnel Syndrome Symptoms Scale
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Apr 2021to 30 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 60 Carpal Tunnel Syndrome patients

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bursa Kestel State Hospital

    Bursa

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
6-item Carpal Tunnel Syndrome Symptoms Scale
Keywords
carpal tunnel syndrome, Boston Carpal Tunnel Questionnaire, validity, Turkish adaptation, reliability, 6-item Carpal Tunnel Syndrome Symptoms Scale
Medical subject headings
Carpal Tunnel Syndrome, Signs and Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6-item Carpal Tunnel Syndrome Symptoms ScaleDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline

  2. 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.

    Measured: baseline

  3. 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.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start30 Apr 2021
  3. Primary completion30 Oct 2021
  4. Study completion30 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05927896
Sponsor's protocol ID
9999999991
Status last verified
Jul 2023
First submitted
23 Jun 2023
Last updated
5 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sevy JO, Sina RE, Varacallo MA. Carpal Tunnel Syndrome. 2023 Oct 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448179/

    PubMed 28846321

  • 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.

    PubMed 21159335

  • 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.

    PubMed 9708370

  • 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.

    PubMed 34385969

  • 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.

    PubMed 8245050

  • 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.

    PubMed 21527135

  • 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.

    PubMed 19229657

  • 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.

    PubMed 34800220

  • 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.

    PubMed 22172153

  • 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.

    PubMed 20874835

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome and Symptoms and Signs, run by Bursa City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-item CTS Symptom Scale (CTS-6) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05927896, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.

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