NCT07114913

Brief Summary

This study aims to compare central sensitization parameters between carpal tunnel syndrome (CTS) patients with extra median symptom distribution and those with typical, median nerve-related symptoms. Extra median sensory spread, observed in some CTS patients beyond the anatomical boundaries of the median nerve, may reflect central sensitization mechanisms. Using the Central Sensitization Inventory and pressure pain threshold measurements, this study will assess whether extra median symptom patterns are associated with increased central sensitization.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

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

Study Start

First participant enrolled

June 21, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 28, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

July 28, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

carpal tunnel syndromecentral sensitizationcentral sensitization inventorypressure pain threshold

Outcome Measures

Primary Outcomes (2)

  • Pressure pain 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

  • Katz hand diagram

    The Katz Hand Diagram is a self-reported symptom map used to support the diagnosis of Carpal Tunnel Syndrome (CTS). Patients are asked to mark areas on a standardized hand diagram where they experience pain, numbness, or tingling. This tool helps clinicians assess whether symptoms follow a median nerve distribution and is commonly used in both clinical and research settings due to its simplicity and diagnostic value.

    3 months

Secondary Outcomes (12)

  • Central sensitization inventory (CSI)

    3 months

  • Visual analog scale

    3 months

  • hand grip strength

    3 months

  • Median nerve conduction studies-latency measurement

    3 months

  • Median nerve motor conduction studies-amplitude measurement

    3 months

  • +7 more secondary outcomes

Study Arms (1)

Patients

Patients with Carpal Tunnel Syndrome

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

Interventions

Nerve ultrasoundDIAGNOSTIC_TEST

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

Patients

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

Patients

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

Patients

Eligibility Criteria

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

Patients with CTS

You may qualify if:

  • Having been diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
  • Being between 18 and 65 years of age
  • Being literate
  • Agreeing to participate in the study

You may not qualify if:

  • Having a history of concomitant diabetes, systemic inflammatory disease, active infection, or malignancy
  • Being \<18 and \>65 years of age
  • Being illiterate
  • Refusing to participate in the study
  • Having a disease associated with neuropathic pain, such as polyneuropathy, radiculopathy, or multiple sclerosis
  • History of injection or surgery for CTS within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Usküdar, 34100, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9.

    PMID: 25630774BACKGROUND
  • Zanette G, Cacciatori C, Tamburin S. Central sensitization in carpal tunnel syndrome with extraterritorial spread of sensory symptoms. Pain. 2010 Feb;148(2):227-236. doi: 10.1016/j.pain.2009.10.025. Epub 2009 Dec 8.

    PMID: 20004060BACKGROUND
  • Sobeeh MG, Ghozy S, Elshazli RM, Landry M. Pain mechanisms in carpal tunnel syndrome: a systematic review and meta-analysis of quantitative sensory testing outcomes. Pain. 2022 Oct 1;163(10):e1054-e1094. doi: 10.1097/j.pain.0000000000002566. Epub 2021 Dec 15.

    PMID: 35050958BACKGROUND
  • Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.

    PMID: 20961685BACKGROUND
  • Fernandez-de-las-Penas C, de la Llave-Rincon AI, Fernandez-Carnero J, Cuadrado ML, Arendt-Nielsen L, Pareja JA. Bilateral widespread mechanical pain sensitivity in carpal tunnel syndrome: evidence of central processing in unilateral neuropathy. Brain. 2009 Jun;132(Pt 6):1472-9. doi: 10.1093/brain/awp050. Epub 2009 Mar 31.

    PMID: 19336461BACKGROUND
  • Feng B, Gong C, You L, Lin Y, Wang Y, Ip WY, Wang Y. Central Sensitization in Patients with Chronic Pain Secondary to Carpal Tunnel Syndrome and Determinants. J Pain Res. 2023 Dec 19;16:4353-4366. doi: 10.2147/JPR.S441786. eCollection 2023.

    PMID: 38145037BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel SyndromePain

Interventions

Nerve Conduction Studies

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Emre Ata

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Central Study Contacts

Feyza Nur Yücel, Specialist

CONTACT

Emre Ata, Assoc. Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2025

First Posted

August 11, 2025

Study Start

June 21, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Data sharing not planned

Locations