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

Shin Kong Wu Ho-Su Memorial Hospital

Status

Enrolling

Conditions

Cervical Radiculopathy

Treatments

Device: true transcutaneous pulsed radiofrequency

Device: Sham device

Study type

Interventional

Funder types

Other

Identifiers

NCT07207356

20250724R

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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