Investigation of the Relationship Between Pain Sensitization and Diagnostic Parameters in Carpal Tunnel Syndrome

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06043141
Collaborator
(none)
32
1
5.9
5.4

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Nerve ultrasound
  • Diagnostic Test: Nerve conduction studies
  • Diagnostic Test: Pressure pain threshold

Detailed Description

Carpal tunnel syndrome (CTS) is the most common nerve entrapment and the main mechanism is compression of the median nerve under the transverse ligament at the wrist level. Its incidence varies between 6.3-11.7% in the general population. In CTS, neuropathic complaints such as numbness, burning and tingling in the palmar face of the first two fingers, which are the innervation area of the median nerve, and fatigue in the hand are the most common symptoms. However, it has been reported that these complaints in most patients are not limited to the innervation area of the median nerve but also spread to other neighboring areas. This has been found to be associated with the development of central sensitization in CTS patients, and extra-median symptoms are suggested to be a clinical marker of pain sensitization. The term central sensitization is explained as an increase in pain sensitivity due to the amplification of neuron-derived signals in the central nervous system.Research shows that ongoing damage to the median nerve stimulates neurons located in the central nervous system, advancing the central sensitization process. Although the diagnosis of CTS is made electrodiagnostically with typical clinical findings, in recent years ultrasound has been frequently used in the diagnosis of CTS because it is non-invasive, fast and reliable. Cross-sectional area and echogenicity of the median nerve are the most frequently evaluated parameters at the carpal tunnel with ultrasound. Studies focus on the clinical relationship of central sensitization in CTS, but its relationship with ultrasonographic and electrodiagnostic data is not yet known.Based on this, this study aimed to investigate the relationship between pain sensitization and electrodiagnostic and ultrasonographic parameters in patients diagnosed with CTS.

Study Design

Study Type:
Observational
Anticipated Enrollment :
32 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Investigation of the Relationship Between Pain Sensitization and Ultrasonographic and Electrodiagnostic Parameters in Carpal Tunnel Syndrome
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients with carpal tunnel syndrome

Patients with carpal tunnel syndrome

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 (PPT) is used to measure deep muscular tissue pain sensitivity.
Other Names:
  • PPT
  • Outcome Measures

    Primary Outcome Measures

    1. Pressure pian threshold [3 months]

      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.

    Secondary Outcome Measures

    1. Central sensitization inventory (CSI) [3 months]

      Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.

    2. hand grip strength [3 months]

      Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer.

    3. Visual analog scale [3 months]

      The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).

    4. Upper extremity nerve conduction studies [3 months]

      Latency, conduction velocity and amplitude values obtained in bilateral median-ulnar motor and sensory nerve conduction studies.

    5. median nerve ultrasound [3 months]

      Median nerve cross-sectional area and echogenicity measurement

    6. Short form-12 [3 months]

      The 12-item Short Form Questionnaire (SF-12) is used for objective measurement of quality of life. Low scores are associated with poor in quality of life.

    7. Self Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS) [3 months]

      S-LANSS is a 7-question scale used to define pain of neuropathic origin and a score of 12 points or more is in favor of the presence of neuropathic pain.

    8. Boston Carpal Tunnel Questionnaire (BCTQ) [3 months]

      The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Two subscores are calculated: Symptom Severity Scale (SSS) and Functional Status Scale (FSS); higher scores indicate worse symptoms or function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings

    • Agreeing to participate in the study

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sultan Abdülhamid Han Training and Research Hospital Istanbul Uskudar Turkey

    Sponsors and Collaborators

    • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

    Investigators

    • Study Chair: Emre Ata, Asst.Prof, Saglik Bilimleri Universitesi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Feyza Nur Yucel, Specialist, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
    ClinicalTrials.gov Identifier:
    NCT06043141
    Other Study ID Numbers:
    • 23-517
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2023