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

NCT04174443 | Completed DMC

• 1 other identifier: KY-2019-266-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal neuralgia; Pulsed radiofrequency; Continuous radiofrequency; High-voltage pulsed radiofrequency combined with low-temperature continuous radiofrequency

Outcome Measures

Primary Outcomes (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.

  Twelve months after the procedure

Secondary Outcomes (11)

• The modified Barrow Neurological Institute Pain Intensity Score

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

• Numeric rating scale

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

• Dose of carbamazepine or oxcarbazepine

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

• Patient satisfaction scores on the 5-point Likert scale

  After 1, 6 and 12 months following the procedure

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

  After 1, 6 and 12 months following the procedure

Study Arms (2)

Pulsed radiofrequency + Continuous radiofrequency

EXPERIMENTAL

Procedure: High-voltage pulsed radiofrequency; Procedure: Low-temperature continuous radiofrequency

Pulsed radiofrequency

ACTIVE COMPARATOR

Procedure: High-voltage pulsed radiofrequency

Interventions

High-voltage pulsed radiofrequency PROCEDURE

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.

Pulsed radiofrequency; Pulsed radiofrequency + Continuous radiofrequency

Low-temperature continuous radiofrequency PROCEDURE

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

Pulsed radiofrequency + Continuous radiofrequency

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (2)

• 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.

  PMID: 40053922 DERIVED

• 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.

  PMID: 33400432 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Fang Luo, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 22, 2019
• Study Start: December 2, 2020
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)