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Trigeminal NeuralgiaPRFCRFNCT04174443

The Efficacy and Safety of Pulsed Radiofrequency Combined With Continuous Radiofrequency for the Trigeminal Neuralgia

A study testing High-voltage pulsed radiofrequency and Low-temperature continuous radiofrequency in people with Trigeminal Neuralgia, run by Beijing Tiantan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Trigeminal neuralgia is a very painful condition, and radiofrequency therapy is reserved for patients who are resistant or intolerant to pharmacological therapy. Continuous radiofrequency and pulsed radiofrequency both have advantages and disadvantages. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Trigeminal Neuralgia
What is being tested?
High-voltage pulsed radiofrequency and Low-temperature continuous radiofrequency
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteChina
Study dates
2 Dec 2020to 26 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd Edition criteria.
  • Aged 18-75 years (inclusive), no sex limitation.
  • Suffering from severe trigeminal neuralgia that cannot be alleviated effectively using conservative medical therapy such as carbamazepine, oxcarbazepine.
  • Numeric rating scale score≥7 before the procedure.
  • Agreed to sign the informed consent form.

Who cannot join

  • Secondary trigeminal neuralgia such as trigeminal neuralgia attributed to a space-occupying lesion or multiple sclerosis.
  • Infection at the puncture site.
  • A history of psychiatric disease.
  • Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest X-ray.
  • Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (II-III of the New York Heart Association classification).
  • A history of abuse of narcotics.
  • A history of receiving continuous radiofrequency to the gasserian ganglion or peripheral branches; glycerol rhizolysis; balloon compression; gamma knife; or any other neuroablative treatments.
  • A history of receiving microvascular decompression.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia

Trigeminal neuralgia is a very painful condition, and radiofrequency therapy is reserved for patients who are resistant or intolerant to pharmacological therapy. Continuous radiofrequency and pulsed radiofrequency both have advantages and disadvantages. Recently, studies have found that pulsed radiofrequency combined with low-temperature (<65 °C) continuous radiofrequency increases the efficacy of the treatment, without leading to a significant increase in complications caused by nerve lesions. However, these reports have some limitations. The investigators plan to conduct a randomized, controlled study to compare the efficacy of applying high-voltage pulsed radiofrequency, with and without low-temperature continuous radiofrequency, to the gasserian ganglion for the treatment of trigeminal neuralgia. The primary outcome will be the effectiveness of the treatment after 12 months which is the percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score between I-III.

Being tested
High-voltage pulsed radiofrequency, Low-temperature continuous radiofrequency
Keywords
Trigeminal neuralgia, Pulsed radiofrequency, Continuous radiofrequency, High-voltage pulsed radiofrequency combined with low-temperature continuous radiofrequency
Medical subject headings
Trigeminal Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-voltage pulsed radiofrequencyProcedure or surgery

    2 Hz of pulsed radiofrequency will be administered at a voltage of 70 V, temperature of 42 °C, pulse width of 20 ms, and treatment time of 600 s.

  • Low-temperature continuous radiofrequencyProcedure or surgery

    Low-temperature continuous radiofrequency will be performed at 60 °C, with a treatment time of 270 s.

Study groups in NCT04174443
Study groupRoleWhat they receive
Pulsed radiofrequency + Continuous radiofrequencyExperimentalNot described
Receives: Procedure: High-voltage pulsed radiofrequency; Procedure: Low-temperature continuous radiofrequency
Pulsed radiofrequencyActive comparatorNot described
Receives: Procedure: High-voltage pulsed radiofrequency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score of I-III

    The modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief) will be used to evaluate the efficacy of the treatment. Twelve months after the procedure, participants with Barrow Neurological Institute scores of I-III will be defined as having received effective treatment. The primary outcome will be the effectiveness of the treatment after 12 months.

    Measured: Twelve months after the procedure

Secondary outcomes (11)

  1. The modified Barrow Neurological Institute Pain Intensity Score

    The modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief) will be used to evaluate the efficacy of the treatment.

    Measured: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure

  2. Numeric rating scale

    Pain was assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).

    Measured: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure

  3. Dose of carbamazepine or oxcarbazepine

    Dose of carbamazepine or oxcarbazepine per day (mg/day)

    Measured: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure

  4. Patient satisfaction scores on the 5-point Likert scale

    1: poor, 2: fair, 3: good, 4: very good, 5: excellent

    Measured: After 1, 6 and 12 months following the procedure

  5. The World Health Organization Quality of Life (WHOQOL)-BREF

    Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale.

    Measured: After 1, 6 and 12 months following the procedure

  6. Numbness

    The Barrow Neurological Institute facial numbness scores (I: No facial numbness; II: Mild facial numbness, not bothersome; III: Facial Numbness, somewhat bothersome; IV: Facial numbness, very bothersome) will be used to evaluate the facial numbness.

    Measured: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure

  7. Number of participants with anesthesia dolorosa

    The participant's facial sensation decreased, accompanied by pain

    Measured: Within 12 months of the procedure

  8. Number of participants with masticator weakness

    Occlusal dysfunction or a lower degree of masseter muscle fullness on one side when biting hard.

    Measured: Within 12 months of the procedure

  9. Number of participants with corneal anesthesia

    When touching the sclera with a cotton swab hair does not cause the eyelids to close quickly.

    Measured: Within 12 months of the procedure

  10. Number of participants with keratitis

    Eye dryness and pain, photophobia, lacrimation, excess mucus and other conditions diagnosed as keratitis by an ophthalmologist

    Measured: Within 12 months of the procedure

  11. Number of participants with adverse reactions

    Nausea, vomiting, and facial hematoma during and after the procedure; headache, dizziness, and cerebrospinal fluid leakage occurring within two weeks of the procedure.

    Measured: Within two weeks of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2019
  2. Study start2 Dec 2020
  3. Primary completion26 Oct 2022
  4. Study completion26 Oct 2022

Resources

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
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04174443
Sponsor's protocol ID
KY-2019-266-01
Acronym
PRFCRF
Status last verified
Aug 2024
First submitted
17 Nov 2019
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Zhao C, Ren H, Shrestha N, Meng L, Shen Y, Luo F. The efficacy of combining pulsed radiofrequency with low-temperature continuous radiofrequency for the treatment of primary trigeminal neuralgia: a randomized controlled trial. J Neurosurg. 2025 Mar 7;143(1):100-110. doi: 10.3171/2024.10.JNS241274. Print 2025 Jul 1.

    PubMed 40053922

  • Ren H, Zhao C, Wang X, Shen Y, Meng L, Luo F. The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-Temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia: Study Protocol for a Prospective, Open-Label, Parall. Pain Physician. 2021 Jan;24(1):89-97.

    PubMed 33400432

Questions about this trial

What is this clinical trial studying?

A study testing High-voltage pulsed radiofrequency and Low-temperature continuous radiofrequency in people with Trigeminal Neuralgia, run by Beijing Tiantan Hospital at 1 site in China.

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 Aug 2024. 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 China. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score of I-III (time frame: Twelve months after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04174443, which also lists 2 linked publications.

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 6 Aug 2024.

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