Cervical RadiculopathyNCT07207356
Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy
A study testing true transcutaneous pulsed radiofrequency in people with Cervical Radiculopathy, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- true transcutaneous pulsed radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Yu-Ting Lin, MD, 886-2-28332211, tim761208@hotmail.com
About this study
Official title: The Efficacy of Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy: a Randomized, Sham-controlled, Double-blind Pilot Study
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.
Read more
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
- Being tested
- true transcutaneous pulsed radiofrequency, Sham device
- Keywords
- cervical radiculopathy, pulsed radiofrequency, transcutaneous pulsed radiofrequency, ultrasound guided
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
true transcutaneous pulsed radiofrequencyDevice
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 deviceDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| true transcutaneous pulsed radiofrequency group | Experimental | Not described Receives: Device: true transcutaneous pulsed radiofrequency |
| Sham transcutaneous pulsed radiofrequency group | Sham comparator | Not described Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Nov 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207356
- Sponsor's protocol ID
- 20250724R
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy: a Randomized, Sham-controlled, Double-blind Pilot Study
- ClinicalTrials.gov ID
- NCT07207356
- Acronym / sponsor ID
- 20250724R
- Conditions
- Cervical Radiculopathy
- Keywords
- cervical radiculopathy, pulsed radiofrequency, transcutaneous pulsed radiofrequency, ultrasound guided
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| true transcutaneous pulsed radiofrequency group | Experimental | Device: true transcutaneous pulsed radiofrequency |
| Sham transcutaneous pulsed radiofrequency group | Sham comparator | Device: Sham device |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 20 and 75 years old.
- Clinical diagnosis of cervical radiculopathy, defined by:
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| true transcutaneous pulsed radiofrequencyparticipants 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 | true transcutaneous pulsed radiofrequency group |
| Sham 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). | Device | Sham transcutaneous pulsed radiofrequency group |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: 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
Participants will rate their average pain over the past week on a scale from 0 (no pain) to 10 (worst imaginable pain).
2 secondary outcomes
Neck Disability Index (NDI)
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing true transcutaneous pulsed radiofrequency in people with Cervical Radiculopathy, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ting Lin, MD (886-2-28332211, tim761208@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.