NCT05970692

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 26, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

July 24, 2023

Last Update Submit

February 20, 2024

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel SyndromePain

Outcome Measures

Primary Outcomes (1)

  • Atroshi-Lyrén 6-item symptoms scale

    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)

    1 week

Study Arms (2)

Healthy Controls

Healthy individuals aged between 18-65 years old

CTS Group

CTS patients aged between 18-65 years old

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CTS patients aged between 18-65 years old

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis Eren University

Bitlis, 13000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel SyndromePain

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Tülay Çevik Saldıran, PhD

CONTACT

+90 (434) 222 83 32tcsaldiran@beu.edu.tr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 1, 2023

Study Start

September 26, 2023

Primary Completion

August 13, 2024

Study Completion

December 30, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

TU(1)