NCT06043141

Brief Summary

The aim of this observational, cross-sectional study is to investigate the relationship between pain sensitization and ultrasonographic and nerve conduction studies in patients diagnosed with carpal tunnel syndrome (CTS). The main questions it aims to answer are:

  • Can threshold values be determined ultrasonographically and electrodiagnostically in patients who develop pain sensitization?
  • Are pressure pain threshold values and central sensitization inventory scores correlated with ultrasonographic and nerve conduction studies of the median nerve?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

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

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

September 12, 2023

Last Update Submit

September 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pressure pian threshold

    Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity.

    3 months

Secondary Outcomes (8)

  • Central sensitization inventory (CSI)

    3 months

  • hand grip strength

    3 months

  • Visual analog scale

    3 months

  • Upper extremity nerve conduction studies

    3 months

  • median nerve ultrasound

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Patients with carpal tunnel syndrome

Patients with carpal tunnel syndrome

Diagnostic Test: Nerve ultrasoundDiagnostic Test: Nerve conduction studiesDiagnostic Test: Pressure pain threshold

Control group

Healthy control

Diagnostic Test: Nerve ultrasoundDiagnostic Test: Pressure pain threshold

Interventions

Nerve ultrasoundDIAGNOSTIC_TEST

Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels

Control groupPatients with carpal tunnel syndrome

Upper extremity nerve conduction studies including median-ulnar sensory and motor responses

Patients with carpal tunnel syndrome

Pain pressure threshold (PPT) is used to measure deep muscular tissue pain sensitivity.

Also known as: PPT
Control groupPatients 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

Patients with CTS

You may qualify if:

  • Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
  • Agreeing to participate in the study

You may not qualify if:

  • Concomitant history of diabetes, systemic inflammatory disease, active infection and malignancy
  • Having a disease with neuropathic pain such as polyneuropathy, radiculopathy,multiple sclerosis
  • Not agreeing to participate in the study
  • History of surgery due to CTS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Emre Ata, Asst.Prof

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

October 1, 2023

Primary Completion

March 5, 2025

Study Completion

May 30, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Dataset sharing is not planned

Locations