NCT06635200

Brief Summary

The aim of this study was to determine the dominant pain phenotype in a group of patients with Carpal Tunnel Syndrome by applying the International Association for the Study of Pain (IASP) criteria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

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
26 days until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

October 8, 2024

Last Update Submit

March 21, 2025

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale

    Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").

    1 minute

Secondary Outcomes (5)

  • Cold Pain Threshold

    2 minutes

  • Hot Pain Threshold

    2 minutes

  • Mechanical Pain Threshold

    3 minutes

  • Static mechanical allodynia

    3 minutes

  • Dynamic Mechanical Allodynia

    3 minutes

Study Arms (3)

Patients with carpal tunnel syndrome with a nociceptive pain phenotype

Patients with carpal tunnel syndrome with a neuropathic pain phenotype

Patients with carpal tunnel syndrome with a nosiplastic pain phenotype

Eligibility Criteria

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

Voluntary participants between the ages of 18-65 who have been diagnosed with Carpal Tunnel Syndrome will be included in the study

You may qualify if:

  • Being diagnosed with CTS
  • 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
  • Hypersensitivity to heat and cold

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 Officials

  • Emrah Afsar, Phd

    Kutahya Health Science University

    PRINCIPAL INVESTIGATOR

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 5, 2024

Primary Completion

March 18, 2025

Study Completion

March 20, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations

TU(1)