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
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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 |
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 |
Group/Cohort | Intervention/treatment |
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Patients with carpal tunnel syndrome
Patients with carpal tunnel syndrome
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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 |
- 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.
- 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.
- 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.
- 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).
- 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.
- median nerve ultrasound [ Time Frame: 3 months ]Median nerve cross-sectional area and echogenicity measurement
- 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.
- 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.
- 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.
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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 |
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
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
Contact: Feyza Nur Yücel, Specialist | 5385577059 ext 90 | dr.fny28@gmail.com |
Turkey | |
Sultan Abdülhamid Han Training and Research Hospital | Recruiting |
Istanbul, Uskudar, Turkey | |
Contact: Feyza Nur Yücel, Specialist 5385577059 ext 90 dr.fny28@gmail.com |
Study Chair: | Emre Ata, Asst.Prof | Saglik Bilimleri Universitesi |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |