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.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 32 is below the median of 60 across 373 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →Shin Kong Wu Ho-Su Memorial Hospital is the lead sponsor of 65 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of cervical radiculopathy, defined by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Apr 2027, 17 months after the start.
Of 203 non-industry interventional studies with no phase under Radiculopathy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 17 months is above that.
Counting every sponsor, half of 215 studies reached it within 12 months; a quarter within 5 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shin Kong Wu Ho-Su Memorial Hospital