Tibial Nerve Elastography in Chemotherapy-Induced Neuropathic Pain
NCT ID: NCT07048431
Last Updated: 2025-07-02
Study Results
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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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2025-09-15
2025-11-15
Brief Summary
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Detailed Description
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The diagnosis of peripheral neuropathy is based on clinical symptoms and is often supported by nerve conduction studies such as electromyography (EMG). However, EMG can be time-consuming and may be insufficient in advanced cases due to loss of nerve action potentials. Furthermore, subclinical cases of neuropathy may go undetected by EMG.
Recent evidence suggests that pathophysiological changes in CIPN may lead to increased nerve stiffness. Shear Wave Elastography (SWE), a non-invasive ultrasound-based technique, allows for quantitative evaluation of tissue elasticity by measuring shear wave velocity (V value in m/s) and calculating stiffness (E value in kPa). Unlike strain elastography, SWE does not require manual compression, making it more objective and reproducible.
This observational, case-control study aims to assess tibial nerve elasticity using SWE in patients diagnosed with CIPN and to compare the findings with healthy controls. A total of 25 patients with CIPN (defined as a DN4 score ≥4) and 25 age-matched healthy volunteers without neuropathy symptoms will be included. All participants will undergo ultrasound and SWE measurements of bilateral tibial nerve.
Parameters recorded will include the anteroposterior and lateral-medial diameter, cross-sectional area, distance from the skin, and the mean shear wave velocity (V value) obtained from three repeated measurements. In addition, demographic and clinical data such as age, gender, chemotherapy protocol and duration, comorbidities, and current medications will be collected.
The primary objective is to investigate whether tibial nerve elasticity differs significantly between CIPN patients and healthy individuals. This study aims to explore SWE as a potential supportive diagnostic tool for early detection or monitoring of CIPN.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Chemotherapy-Induced Tibial Neuropathy Group
This group includes adult patients diagnosed with peripheral tibial neuropathy attributed to chemotherapy treatment. Participants must exhibit clinical signs or symptoms consistent with tibial nerve involvement, such as distal lower limb pain, paresthesia, weakness, or altered sensation in the tibial nerve distribution.
Shear Wave Elastography Measurement
It is a non-invasive imaging technique used to evaluate tissue stiffness. This method involves the use of ultrasound-based shear wave elastography to assess bilateral tibial nerve, by measuring the speed of shear wave propagation through the tissue. Stiffness values are expressed in kilopascals (kPa).
Healthy Volunteers Group
This group consists of adult participants with no known acute or chronic medical conditions, neurological disorders, or history of chemotherapy or neurotoxic drug exposure. Individuals must be in good general health, as determined by medical history, physical examination. This group serves as a control population to establish baseline measurements.
Shear Wave Elastography Measurement
It is a non-invasive imaging technique used to evaluate tissue stiffness. This method involves the use of ultrasound-based shear wave elastography to assess bilateral tibial nerve, by measuring the speed of shear wave propagation through the tissue. Stiffness values are expressed in kilopascals (kPa).
Interventions
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Shear Wave Elastography Measurement
It is a non-invasive imaging technique used to evaluate tissue stiffness. This method involves the use of ultrasound-based shear wave elastography to assess bilateral tibial nerve, by measuring the speed of shear wave propagation through the tissue. Stiffness values are expressed in kilopascals (kPa).
Eligibility Criteria
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Inclusion Criteria
* DN4 score ≥4
* Anatomical suitability for tibial nerve ultrasound and SWE assessment
* Providing written informed consent
Exclusion Criteria
* Alcohol use
* Polyneuropathy due to genetic or toxic causes
* Fracture, skin lesion, or edema in the lower extremity
* Severe systemic diseases (e.g., liver, kidney, heart, or lung)
* Inability to visualize the tibial nerve anatomically
* Cognitive or psychiatric disorders preventing cooperation
18 Years
75 Years
ALL
Yes
Sponsors
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Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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Ufuk Turan, MD
Principal Investigator
Locations
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Ankara Etlik City Hospital
Ankara, Etlik, Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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Tibial Nerve Elastography
Identifier Type: -
Identifier Source: org_study_id
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