An interventional study of true transcutaneous pulsed radiofrequency and Sham device in Cervical Radiculopathy, sponsored by Shin Kong Wu Ho-Su Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Shin Kong Wu Ho-Su Memorial Hospital · Not applicable, Interventional, and Treatment
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.
Clinical diagnosis of cervical radiculopathy, defined by:
Exclusion Criteria:
Device: true transcutaneous pulsed radiofrequency
Device: 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. 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 into two 15-minute phases, with treatment administered 3 times per week for 4 weeks (12 sessions in total).
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).
Numeric Rating Scale (NRS)
Participants will rate their average pain over the past week on a scale from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 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
Neck Disability Index (NDI)
The NDI consists of ten items. These include seven questions related to daily functional activities, two addressing symptom severity, and one focused on concentration. The total score is calculated by summing the responses to all items, with higher scores reflecting greater levels of disability. According to Vernon et al, scores of 0-4 indicate no disability, 5-14 indicate mild disability, 15-24 moderate disability, 25-34 severe disability, and scores above 35 reflect complete disability.
Time frame: 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
During the intervention and follow-up period, participants who experience unbearable pain will be allowed to take rescue medication, consisting of 500 mg of oral acetaminophen up to four times per day. The frequency and amount of rescue medication used will be documented at each assessment point.
Time frame: 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
Plan to share: Undecided
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Shin Kong Wu Ho-Su Memorial Hospital