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.
Age between 20 and 75 years old.
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
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
Parallel
true transcutaneous pulsed radiofrequency
Deviceparticipants 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).
Sham device
Deviceparticipants 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).
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.
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.
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