Tibial Nerve Elastography in Chemotherapy-Induced Neuropathic Pain

NCT07048431 | Not Yet Recruiting

• 1 other identifier: Tibial Nerve Elastography
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Tibial Neuropathy

Keywords

Chemotherapy-induced Peripheral Neuropathy; Tibial Neuropathy

Outcome Measures

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.

  Single SWE measurement performed within the first week of study inclusion

Study Arms (2)

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.

Diagnostic Test: Shear Wave Elastography Measurement

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.

Diagnostic Test: Shear Wave Elastography Measurement

Interventions

Shear Wave Elastography Measurement DIAGNOSTIC_TEST

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).

Chemotherapy-Induced Tibial Neuropathy Group; Healthy Volunteers Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Age between 18 and 75 years
• DN4 score ≥4
• Anatomical suitability for tibial nerve ultrasound and SWE assessment
• Providing written informed consent

You may not qualify if:

• Presence of diabetes mellitus
• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Etlik, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tibial Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Ufuk Turan

CONTACT

+905395594772; drufukturan@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 2, 2025
• Study Start: September 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 15, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

TU (1)