Symptom Distribution and Pain Sensitization in Carpal Tunnel Syndrome

NCT ID: NCT07114913

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-21

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy, typically presenting with numbness and tingling in the thumb, index, and middle fingers due to median nerve compression at the wrist. However, some patients report symptom spread beyond the median nerve distribution, involving ulnar regions of the hand, forearm, shoulder, or even scapular areas. This phenomenon, known as extra median symptom distribution, has been increasingly associated with central sensitization (CS).This study aims to compare central sensitization parameters between CTS patients with typical symptoms and those showing extra median spread. Pressure pain threshold (PPT) and Central Sensitization Inventory (CSI) scores will be used to evaluate sensitization levels. The initial hypothesis of this study was that patients with extra-median symptoms would exhibit lower PPT values and higher CSI scores, indicating greater central sensitivity. Findings may highlight the need to consider central mechanisms in CTS management and promote more personalized treatment approaches.

Conditions

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Carpal Tunnel Syndrome Central Sensitisation Pain, Radiating

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

Patients with Carpal Tunnel Syndrome

Nerve ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Nerve conduction studies

Intervention Type DIAGNOSTIC_TEST

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

Pressure pain threshold

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Nerve ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Nerve conduction studies

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

Intervention Type DIAGNOSTIC_TEST

Pressure pain threshold

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emre Ata

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Locations

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Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Usküdar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Feyza Nur Yücel, Specialist

Role: CONTACT

(0216) 542 20 00 ext. 90

Emre Ata, Assoc. Prof

Role: CONTACT

(0216) 542 20 00 ext. 90

Facility Contacts

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Feyza Nur Yücel, Specialist

Role: primary

Role: backup

(0216) 542 20 00 ext. 90

References

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

Reference Type BACKGROUND
PMID: 25630774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20004060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35050958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20961685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19336461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38145037 (View on PubMed)

Other Identifiers

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25/603

Identifier Type: -

Identifier Source: org_study_id

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