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

NCT ID: NCT07207356

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-04-30

Brief Summary

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.

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

true transcutaneous pulsed radiofrequency group

Group Type: EXPERIMENTAL

true transcutaneous pulsed radiofrequency

Intervention Type: 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).

Sham transcutaneous pulsed radiofrequency group

Group Type: SHAM_COMPARATOR

Sham device

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Ting Lin, MD

Role: CONTACT

tim761208@hotmail.com

886-2-28332211

Facility Contacts

Yu-Ting Lin, MD

Role: primary

tim761208@hotmail.com

886-2-28332211

Other Identifiers

20250724R

Identifier Type: -

Identifier Source: org_study_id