Tibial Nerve Elastography in Chemotherapy-Induced Neuropathic Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAnkara Etlik City Hospital
About this trial
This observational study aims to evaluate the tibial nerve stiffness using Shear Wave Elastography (SWE) in patients with chemotherapy-induced peripheral neuropathy (CIPN) compared to healthy volunteers. A total of 25 patients with a DN4 score ≥4 and 25 healthy controls will be assessed. Parameters including nerve diameter, cross-sectional area, depth, and shear wave velocity (V value) will be measured. Demographic and clinical data such as age, gender, chemotherapy protocol, duration, comorbidities, and medications will also be collected. The goal is to investigate SWE as a non-invasive diagnostic tool for CIPN by identifying differences in nerve elasticity between groups.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 75 years
DN4 score ≥4
Anatomical suitability for tibial nerve ultrasound and SWE assessment
Providing written informed consent
Disqualifiers
Presence of diabetes mellitus
Alcohol use
Polyneuropathy due to genetic or toxic causes
Fracture, skin lesion, or edema in the lower extremity
Trial population
The study included adults aged 18-75 years, divided into two groups: 25 patients with chemotherapy-induced peripheral neuropathy (CIPN) and DN4 scores ≥4, and 25 healthy controls without neuropathy symptoms. All participants underwent clinical screening and were anatomically suitable for tibial nerve ultrasound and shear wave elastography (SWE). Both tibial nerves were evaluated in each subject. Individuals with diabetes mellitus, alcohol use, genetic or toxic neuropathies, systemic diseases, lower limb trauma or lesions, or cognitive/psychiatric disorders affecting cooperation were excluded. The goal was to ensure a homogeneous population for accurate elastographic comparison.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Shear Wave Elastography Measurement
Diagnostic testIt 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).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Chemotherapy-Induced Tibial Neuropathy Group1 intervention
Group B: Healthy Volunteers Group1 intervention
Trial outcomes
Primary outcomes
1
Shear Wave Elastography (SWE) Stiffness Value
Shear Wave Elastography (SWE) is an imaging technique used to quantify tissue stiffness by measuring the propagation speed (V, m/s) of shear waves and converting it into elasticity values (E, kilopascals, kPa). Higher values may indicate fibrosis or increased tension, while lower values may reflect fatty infiltration or atrophy. In peripheral nerves, SWE has been used to assess elasticity in neuropathic conditions. Research shows that affected nerves in neuropathy exhibit increased stiffness compared to healthy nerves. Both shear wave velocity (V) and elasticity modulus (E) can be measured, offering objective, quantitative data to detect and monitor structural nerve changes.
Time frame
Single SWE measurement performed within the first week of study inclusionSponsors and contacts
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Source ClinicalTrials.gov
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