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Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale

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ClinicalTrials.gov Identifier: NCT05970692
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : February 22, 2024
Sponsor:
Collaborator:
Bitlis Eren University
Information provided by (Responsible Party):
Ilke KARA, Dokuz Eylul University

Study Description
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Brief Summary:
This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L scale) and to perform validity and reliability evaluations.

Condition or disease
Carpal Tunnel Syndrome

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Actual Study Start Date : September 26, 2023
Estimated Primary Completion Date : August 13, 2024
Estimated Study Completion Date : December 30, 2024

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Groups and Cohorts
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Group/Cohort
Healthy Controls
Healthy individuals aged between 18-65 years old
CTS Group
CTS patients aged between 18-65 years old


Outcome Measures
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Primary Outcome Measures :
  1. Atroshi-Lyrén 6-item symptoms scale [ Time Frame: 1 week ]
    The A-L scale consists of 6 items that inquire about severity and frequency of night and daytime numbness and tingling and pain. For each patient the item responses are scored from 1 (best) to5 (worst) and then averaged for the 6 items to yield a total score (only 1 missing item response is allowed)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
CTS patients aged between 18-65 years old
Criteria

Inclusion Criteria:

  • Aged between 18-65 years old,
  • Had symptoms of numbness, tingling, weakness and pain in the hands for at least 1 month,
  • Assessed through provocation tests and physical examination to match the median nerve distribution.

Exclusion Criteria:

  • Not willing to participate in the study,
  • Clinical or electrophysiological signs of proximal nerve compression,
  • Diabetes or other metabolic disease,
  • Rheumatoid arthritis or other general inflammatory diseases.
Contacts and Locations
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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): NCT05970692


Contacts
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Contact: Tülay Çevik Saldıran, PhD +90 (434) 222 83 32 tcsaldiran@beu.edu.tr

Locations
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Turkey
Bitlis Eren University Recruiting
Bitlis, Turkey, 13000
Contact: Tülay Çevik Saldıran, PhD    +90 (434) 222 83 32    tcsaldiran@beu.edu.tr   
Sponsors and Collaborators
Ilke KARA
Bitlis Eren University
More Information
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Responsible Party: Ilke KARA, Co-Principal Investigator, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT05970692    
Other Study ID Numbers: BEU-KTS-01
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024
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 Ilke KARA, Dokuz Eylul University:
Carpal Tunnel Syndrome
Pain
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries