NCT06635109

Brief Summary

The aim of our study was to examine the effect of different severities of Carpal Tunnel Syndrome on activity and participation within the framework of the International Classification of Functioning, Disability and Health (ICF).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

October 8, 2024

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Short Form - 36 Quality of Life Questionnaire (SF-36)

    SF-36 is a health-related quality of life questionnaire consisting of 8 scales (physical functioning, role limitations due to physical health problems, pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health). Responses to items are converted into scale scores from 0 (worst health) to 100 (best health).

    15 minutes

  • Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)

    Each question in the scale is scored between 1 and 5. The results range from 0 (no difficulty or symptoms) to 100 (no activity or very severe symptoms).

    10 minutes

  • Michigan Hand Questionnaire (MHQ)

    The Michigan Hand Questionnaire (MHQ) is a hand-specific questionnaire that measures the health status of patients with acute and chronic hand disorders. The MHQ is an outcome tool consisting of 37 questions and 6 domains: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with function. Each domain is scored using an unweighted method by summing the responses on each scale (1 to 5) and normalising the scores to a scale from 0 to 100. A lower score indicates more severe disability, other than pain. The final score is obtained by averaging the six scores after inverting the pain score.

    15 minutes

  • Boston Carpal Tunnel Questionnaire - Functional Status Scale

    It is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.

    5 minutes

Study Arms (3)

Mild carpal tunnel syndrome

Middle carpal tunnel syndrome

Severe carpal tunnel syndrome

Eligibility Criteria

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

Individuals between the ages of 18-65 who were diagnosed with CTS in the dominant hand and who volunteered to participate in the study were included.

You may qualify if:

  • Diagnosis of CTS in the dominant hand
  • Being between the ages of 18-65
  • Volunteering to participate in the study

You may not qualify if:

  • Having systemic inflammatory disease
  • Having a disease that may cause polyneuropathy such as diabetes mellitus
  • Having a pacemaker
  • Having a disease affecting the central nervous system
  • Having cervical radiculopathy
  • History of previous operation or local steroid injection due to CTS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

November 15, 2024

Primary Completion

January 10, 2026

Study Completion

January 15, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations