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Percutaneous electrical nerve stimulation as a non-pharmacological strategy in oxaliplatin-induced neuropathy: evidence from a randomized clinical trial

Efficacy of ultrasound-guided percutaneous neuromodulation on the quality of life in treating individuals with oxaliplatin-induced peripheral neuropathy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001390572
Enrollment
20
Registered
2024-11-22
Start date
2025-01-09
Completion date
2025-06-02
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To date, no randomized clinical trial (RCT) has been conducted to determine the feasibility and efficacy of peripheral nerve stimulation in the treatment of CIPN. Therefore, the present RCT aims to use ultrasound-guided percutaneous neuromodulation to improve quality of life and neuropathic symptomatology in individuals with colon cancer who have developed oxaliplatin-induced peripheral neuropathies during chemotherapy treatment. The hypothesis is that this treatment will increase the patients' quality of life and improve their neuropathic symptomatology.

Interventions

Percutaneous Ultrasound-Guided Neuromodulation Group: The following steps will be undertaken: 1. Ultrasound Localization of the Nerve: A linear probe will be positioned on the anterior aspect of the elbow in a transverse plane. In this view, the median nerve will be visualized between the heads of the pronator teres muscle, medial to the brachial artery (1 min). 2. Selection of the Approach Type: Depending on the anatomical disposition of the nerve, either a short-axis approach (introducing the

Percutaneous Ultrasound-Guided Neuromodulation Group: The following steps will be undertaken: 1. Ultrasound Localization of the Nerve: A linear probe will be positioned on the anterior aspect of the elbow in a transverse plane. In this view, the median nerve will be visualized between the heads of the pronator teres muscle, medial to the brachial artery (1 min). 2. Selection of the Approach Type: Depending on the anatomical disposition of the nerve, either a short-axis approach (introducing the needle in a plane parallel to the probe) or a long-axis approach (introducing the needle from the medial end of the probe) may be employed (1 min). 3. Assessment of Safety Measures: Localization of surrounding veins and arteries will be conducted using the Doppler function of the ultrasound machine, along with measurement of the distance from the skin to the target nerve to determine the appropriate needle size (5 min). 4. Pre-Intervention Measures: Hand washing, donning gloves and a probe cover, and skin antisepsis using a chlorhexidine-based antiseptic will be performed (5 min). 5. Ultrasound-Guided Intervention: The needle will be inserted and advanced toward the target tissue with real-time visualization using ultrasound. The needle should be positioned within the epineurium of the median nerve. Subsequently, a transcutaneous electrode will be placed on the ventral aspect of the forearm, and a monopolar electrode will be connected to the needle, aiming to reproduce a motor or sensory response over the nerve (1 min). 6. Peripheral Nerve Electrostimulation: A peripheral nerve stimulator (Endomed 484) will be utilized to apply a continuous biphasic rectangular current, adjusting the frequency to 1-2 Hz and the pulse width to 200-250 µs. The intensity will be gradually increased to a tolerable threshold for the patient (the patient will be asked after each increase in intensity until the maximum point prior to reproducing pain is found) and maintained for the 30-minute duration of stimulation. To ensure that the nerve is being correctly stimulated, involuntary contractions will be observed in the musculature that innervates and the patient will report a tingling sensation along the nerve territory. 7. Post-Intervention Measures: The needle will be withdrawn, followed by 30 seconds of compression with a sterile gauze (1 min). The treatment will be performed in a treatment room of the hospital and will be applied by a physiotherapist with expertise in ultrasound.

Sponsors

Universidad Europea de Madrid
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Subjects over 18 years of age, diagnosed with a gastrointestinal malignancy and on an oxaliplatin-based chemotherapy regimen, who have experienced symptoms of chemotherapy-induced peripheral neuropathy and have life expectancy greater than 6 months.

Exclusion criteria

Patients will be excluded if they have a history of peripheral neuropathy caused by reasons other than chemotherapy, are diagnosed with peripheral vascular disease, uncontrolled arrhythmias, epilepsy, Raynaud's syndrome, diabetes or severe mental disorders, pregnant women, belonephobia, participants in other clinical trials for the treatment of neuropathy, and patients who cannot communicate in Spanish.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026