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

NARecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
Cervical Radiculopathy
Interventions
DEVICE

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 into two 15-minute phases, with treatment administered 3 times per week for 4 weeks (12 sessions in total).

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. 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).

Trial Locations (1)

Unknown

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital, Taipei

All Listed Sponsors
lead

Shin Kong Wu Ho-Su Memorial Hospital

OTHER