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Recruiting NCT07114913

Symptom Distribution and Pain Sensitization in Carpal Tunnel Syndrome

Observational Carpal Tunnel Syndrome Central Sensitisation Pain, Radiating

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nerve ultrasound, Nerve conduction studies, Pressure pain threshold.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome, Central Sensitisation, Pain, Radiating. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Central Sensitization Parameters Based on Extra Median Symptom Distribution in Carpal Tunnel Syndrome: A Cross-sectional Study

Overview

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

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.

Interventions

  • Diagnostic test Nerve ultrasound
    Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels
  • Diagnostic test Nerve conduction studies
    Upper extremity nerve conduction studies including median-ulnar sensory and motor responses
  • Diagnostic test Pressure pain threshold
    Pain pressure threshold is used to measure deep muscular tissue pain sensitivity.

Primary outcome measures

  • Pressure pain threshold [Time frame: 3 months]
  • Katz hand diagram [Time frame: 3 months]
Secondary outcome measures (12)
  • Central sensitization inventory (CSI) [Time frame: 3 months]
  • Visual analog scale [Time frame: 3 months]
  • hand grip strength [Time frame: 3 months]
  • Median nerve conduction studies-latency measurement [Time frame: 3 months]
  • Median nerve motor conduction studies-amplitude measurement [Time frame: 3 months]
  • Median nerve sensory conduction studies-amplitude measurement [Time frame: 3 months]
  • Median nerve conduction studies- conduction velocity measurement [Time frame: 3 months]
  • Median nerve ultrasound cross-sectional area measurement [Time frame: 3 months]
  • Median nerve ultrasound echogenicity measurement [Time frame: 3 months]
  • Short form-12 [Time frame: 3 months]
  • Self Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS) [Time frame: 3 months]
  • Boston Carpal Tunnel Questionnaire (BCTQ) [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Sultan Abdülhamid Han Training and Research Hospital — Istanbul

Publications

  • Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9. PMID 25630774
  • 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 20004060
  • 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 35050958
  • 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 20961685
  • 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 19336461
  • 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 38145037

Identifiers

NCT: NCT07114913 · 25/603

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗