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NCT Number: NCT07048431

Tibial Nerve Elastography in Chemotherapy-Induced Neuropathic Pain

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, Etlik, 06000, Turkey (Türkiye)

About this study

Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect observed in 30-40% of patients receiving neurotoxic chemotherapy. CIPN typically presents with sensory symptoms such as paresthesia, numbness, balance disturbances, heightened pain sensitivity, and deep tendon reflex loss. The severity and progression of neuropathy vary widely among patients.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Shear Wave Elastography (SWE) Stiffness Value

    Time frame: Single SWE measurement performed within the first week of study inclusion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ufuk Turan

CONTACT

[email protected]

+905395594772 ext. TR

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Evaluation of Chemotherapy-Induced Neuropathic Pain Using Shear Wave Elastography Measurements of the Tibial Nerve

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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