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

NCT07207356 | Recruiting

• 1 other identifier: 20250724R
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

cervical radiculopathy; pulsed radiofrequency; transcutaneous pulsed radiofrequency; ultrasound guided

Outcome Measures

Primary Outcomes (1)

• 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).

  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

Secondary Outcomes (2)

• Neck Disability Index (NDI)

  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

  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

Study Arms (2)

true transcutaneous pulsed radiofrequency group

EXPERIMENTAL

Device: true transcutaneous pulsed radiofrequency

Sham transcutaneous pulsed radiofrequency group

SHAM COMPARATOR

Device: Sham device

Interventions

true transcutaneous pulsed radiofrequency 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).

true transcutaneous pulsed radiofrequency group

Sham device 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).

Sham transcutaneous pulsed radiofrequency group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 and 75 years old.
• Clinical diagnosis of cervical radiculopathy, defined by:
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Yu-Ting Lin, MD

CONTACT

886-2-28332211; tim761208@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 6, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

TW (1)