Ultrasound-guided transcutaneous pulsed radiofrequency for cervical nerve root pain
The Efficacy of Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy: a Randomized, Sham-controlled, Double-blind Pilot Study
This study will test whether ultrasound-guided transcutaneous pulsed radiofrequency can reduce neck and arm pain in adults with cervical radiculopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Shin Kong Wu Ho-Su Memorial Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07207356 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study will compare true ultrasound-guided transcutaneous pulsed radiofrequency (TCPRF) with a sham device in adults aged 20–75 who have MRI/CT-confirmed cervical nerve root compression and at least 6 weeks of arm pain scoring 4/10 or higher. Treatments are delivered noninvasively with ultrasound guidance to target the affected cervical nerve root(s). Participants who meet clinical and imaging criteria will receive either active TCPRF or a sham procedure and will be followed for safety and pain outcomes. The trial will collect pain scores and adverse events to determine whether TCPRF provides meaningful symptom relief and is well tolerated.
Who should consider this trial
Good fit: Ideal candidates are adults 20–75 years old with clinical signs of cervical radiculopathy, corresponding MRI/CT-confirmed nerve root compression, symptoms longer than 6 weeks, and arm pain of at least 4/10 who can consent and comply with visits.
Not a fit: Patients with only axial neck pain, motor deficits, prior cervical spine surgery, symptoms attributable to shoulder/elbow/wrist or other musculoskeletal disorders, serious underlying pathology, or who do not meet the imaging and pain criteria are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could offer a noninvasive, outpatient option to reduce neck and arm pain from cervical radiculopathy and potentially avoid more invasive procedures.
How similar studies have performed: Invasive pulsed radiofrequency has shown benefits for nerve-related pain and TCPRF has produced promising results in animal studies and clinical work for knee and shoulder conditions, but TCPRF has not previously been tested for cervical radiculopathy specifically.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 20 and 75 years old. * Clinical diagnosis of cervical radiculopathy, defined by: 1. Presence of neck pain or paresthesia radiating to the unilateral upper extremity with radicular and dermatomal pattern; 2. Positive Spurling's test; 3. 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 Exclusion Criteria: * 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
Where this trial is running
Taipei
- Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Yu-Ting Lin, MD
- Email: tim761208@hotmail.com
- Phone: 886-2-28332211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.