NCT07249177

Brief Summary

The aim of this study was to investigate the validity and reliability of the Upper Extremity Functional Index in patients with carpal tunnel syndrome. This cross-sectional study included 101 patients diagnosed with carpal tunnel syndrome at a university hospital. Patients were administered the Upper Extremity Functional Index, Michigan Hand Outcomes Questionnaire, and Boston Carpal Tunnel Questionnaire surveys. Test-retest reliability, internal consistency, and construct validity of the Upper Extremity Fuctional Index were evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 28, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

November 17, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

psychometricscarpal tunnel syndromeoutcome measuresupper extremity functional index

Outcome Measures

Primary Outcomes (3)

  • Upper Extremity Functional Index

    It is a 20-item scale scored using a 4-point Likert scale (0 = Extremely difficult/I cannot do it, 4 = I do not experience any difficulty). The patient scores between 0 and 80, and it is recommended that the total score be used in studies. A high score indicates that the patient has good upper extremity function.

    The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome) and 15 days after the baseline assessment.

  • Michigan Hand Outcomes Questionnaire

    This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.

    The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome)

  • Boston Carpal Tunnel Questionnaire

    It has been developed to assess the severity of symptoms and functional status in patients with carpal tunnel syndrome. The symptom severity scale consists of 11 questions, while the functional status scale consists of 8 questions. Each question is scored between 1 and 5. A higher symptom severity or functional status score indicates worse symptoms or functional impairment.

    The questionnaire was administered at baseline (after diagnosis of carpal tunnel syndrome)

Study Arms (1)

Patients aged 18-65 years diagnosed with carpal tunnel syndrome.

Other: Questionnaire

Interventions

The Upper Extremity Functional Index (at the first session and after 2 weeks), the Michigan Hand Outcomes Questionnaire and the Boston Carpal Tunnel Questionnaire were administered to patients using a face-to-face assessment method.

Patients aged 18-65 years diagnosed with carpal tunnel syndrome.

Eligibility Criteria

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

This study included patients aged 18-65 years who were diagnosed with carpal tunnel syndrome after visiting the neurology outpatient clinic of a university hospital, who volunteered, who had no history of other trauma, disease, or surgery in the affected limb, and who had no communication difficulties. The patients were included before starting any conservative or surgical treatment programme.

You may qualify if:

  • To be diagnosed with carpal tunnel syndrome, to be a volunteer, and to be between the ages of 18 and 65 years.

You may not qualify if:

  • no history of other trauma, disease or surgery in the affected limb and difficulty communicating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20170, Turkey (Türkiye)

Location

Related Publications (2)

  • Aytar A, Yuruk ZO, Tuzun EH, Baltaci G, Karatas M, Eker L. The Upper Extremity Functional Index (UEFI): cross-cultural adaptation, reliability, and validity of the Turkish version. J Back Musculoskelet Rehabil. 2015;28(3):489-95. doi: 10.3233/BMR-140545.

    PMID: 25322741BACKGROUND
  • Sousa RL, Moraes VY, Zobiole AF, Nakachima LR, Belloti JC. Diagnostic criteria and outcome measures in randomized clinical trials on carpal tunnel syndrome: a systematic review. Sao Paulo Med J. 2023 Apr 17;141(6):e2022086. doi: 10.1590/1516-3180.2022.0086.07022023. eCollection 2023.

    PMID: 37075455BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 25, 2025

Study Start

June 28, 2021

Primary Completion

November 18, 2022

Study Completion

November 18, 2022

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations