Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy

Официальное название

The Efficacy of Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy: a Randomized, Sham-controlled, Double-blind Pilot Study

Обзор

Cervical radiculopathy (CR) is a painful condition caused by irritation of the cervical nerve roots, often leading to neck, shoulder, and arm pain, sometimes with numbness or weakness. These symptoms can reduce quality of life and place a burden on healthcare systems. Current treatments, such as physical therapy, cervical traction, and medication, are often not fully effective. Pulsed radiofrequency (PRF) has shown benefits for nerve-related pain, but because it requires an invasive procedure, its use is limited. Transcutaneous pulsed radiofrequency (TCPRF) is a non-invasive version of PRF. It has shown promising results in animal studies and in clinical research for knee and shoulder conditions, but has not been tested for CR. Recent improvements in ultrasound allow more precise targeting of cervical nerve roots, making ultrasound-guided TCPRF a potentially safe and accessible treatment option. This pilot study will evaluate the efficacy and safety of ultrasound-guided TCPRF in patients with CR compared to a sham treatment. A total of 32 participants with CR lasting more than six weeks will be randomly assigned to either TCPRF or sham treatment. Both groups will receive 12 treatment sessions over four weeks, combined with a standard rehabilitation program. The main outcome is pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes include neck-related disability, medication use, and any side effects.

Вмешательства

• Устройство true transcutaneous pulsed radiofrequency
  participants will receive ultrasound guidance to localize the target cervical nerve root (e.g., C5-C7) before treatment. A high-frequency linear transducer will be used with the patient in a sitting position. Transcutaneous pulsed radiofrequency (TCPRF) will be applied using the StimOn™ Pain Relief System (GM2439, Gimer Medical Co., Ltd, Taiwan; FDA 510(k) No. K213802). The device delivers a 500-kHz symmetric biphasic sine wave at 2 Hz with a 25-ms pulse. Each session lasts 30 minutes, divided i
• Устройство Sham device
  participants will receive ultrasound guidance to localize the target cervical nerve root (e.g., C5-C7) before treatment. A high-frequency linear transducer will be used with the patient in a sitting position. Sham device will be applied. No active current will be delivered. Each session lasts 30 minutes, divided into two 15-minute phases, with treatment administered 3 times per week for 4 weeks (12 sessions in total).

Первичные конечные точки

• Numeric Rating Scale (NRS) [Срок оценки: baseline, at the end of week 2, at the end of week 4 (post-treatment), and at a 3-month follow-up after the intervention]

Вторичные конечные точки (2)

• Neck Disability Index (NDI) [Срок оценки: baseline, at the end of week 2, at the end of week 4 (post-treatment), and at a 3-month follow-up after the intervention]
• medication usage [Срок оценки: baseline, at the end of week 2, at the end of week 4 (post-treatment), and at a 3-month follow-up after the intervention]

Критерии участия

Критерии включения

• Age between 20 and 75 years old.
• Clinical diagnosis of cervical radiculopathy, defined by:

• Presence of neck pain or paresthesia radiating to the unilateral upper extremity with radicular and dermatomal pattern;
• Positive Spurling's test;
• Positive cervical distraction test
• Symptoms lasting for over 6 weeks
• Numeric Rating Scale (NRS) for arm pain ≥ 4 out of 10
• MRI or CT-confirmed nerve root compression, corresponding to clinical symptoms.
• Able to provide written informed consent and comply with study procedures

Критерии исключения

• History of cervical spine surgery.
• Motor deficit on involving limb
• Presence of axial neck pain without radicular symptoms
• Symptoms from shoulder, elbow, or wrist joint or other musculoskeletal co-morbidity such as rheumatologic disease or carpal tunnel syndrome
• Evidence of serious underlying pathology (e.g., tumor, infection, fracture, or myelopathy)
• Prior exposure to epidural steroid injection or pulsed radiofrequency therapy within the past 6 months
• Presence of pregnancy or breastfeeding.
• History of epilepsy or electronic devices implanted in the body
• Active infection or skin disease at the stimulator contact site
• Allergy to electrode patch
• Unable to understand the study protocol or provide written

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Shin Kong Wu Ho-Su Memorial Hospital — Taipei

Идентификаторы

NCT: NCT07207356 · 20250724R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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