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

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ClinicalTrials.gov Identifier: NCT06043141
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : October 25, 2023
Sponsor:
Information provided by (Responsible Party):
Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Description
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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
Central Sensitisation Carpal Tunnel Syndrome 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
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Study Type : Observational
Estimated 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
Actual Study Start Date : October 1, 2023
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : March 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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 Name: PPT


Outcome Measures
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Primary Outcome Measures :
  1. Pressure pian threshold [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]
    Latency, conduction velocity and amplitude values obtained in bilateral median-ulnar motor and sensory nerve conduction studies.

  5. median nerve ultrasound [ Time Frame: 3 months ]
    Median nerve cross-sectional area and echogenicity measurement

  6. Short form-12 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with CTS
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043141


Contacts
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Contact: Feyza Nur Yücel, Specialist 5385577059 ext 90 dr.fny28@gmail.com

Locations
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Turkey
Sultan Abdülhamid Han Training and Research Hospital Recruiting
Istanbul, Uskudar, Turkey
Contact: Feyza Nur Yücel, Specialist    5385577059 ext 90    dr.fny28@gmail.com   
Sponsors and Collaborators
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Investigators
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Study Chair: Emre Ata, Asst.Prof Saglik Bilimleri Universitesi
More Information
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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: September 21, 2023    Key Record Dates
Last Update Posted: October 25, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Dataset sharing is not planned

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries