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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Procedure: High-voltage pulsed radiofrequency; Procedure: Low-temperature continuous radiofrequency

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Luo, MD; Phone Number: +8613611326978; Email: 13611326978@163.com
• Study Contact Backup: Name: Hao Ren, MD; Phone Number: +8618701229893; Email: renh2014@mail.ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed radiofrequency + Continuous radiofrequency	Procedure: High-voltage pulsed radiofrequency; 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.; Procedure: Low-temperature continuous radiofrequency; Low-temperature continuous radiofrequency will be performed at 60 °C, with a treatment time of 270 s.
Active Comparator: Pulsed radiofrequency	Procedure: High-voltage pulsed radiofrequency; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Numeric rating scale	Pain was assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).	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	Dose of carbamazepine or oxcarbazepine per day (mg/day)	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	1: poor, 2: fair, 3: good, 4: very good, 5: excellent	After 1, 6 and 12 months following the procedure
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.	After 1, 6 and 12 months following the procedure
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.	On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Number of participants with anesthesia dolorosa	The participant's facial sensation decreased, accompanied by pain	Within 12 months of the procedure
Number of participants with masticator weakness	Occlusal dysfunction or a lower degree of masseter muscle fullness on one side when biting hard.	Within 12 months of the procedure
Number of participants with corneal anesthesia	When touching the sclera with a cotton swab hair does not cause the eyelids to close quickly.	Within 12 months of the procedure
Number of participants with keratitis	Eye dryness and pain, photophobia, lacrimation, excess mucus and other conditions diagnosed as keratitis by an ophthalmologist	Within 12 months of the procedure
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.	Within two weeks of the procedure

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Fang Luo, MD, Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): October 26, 2022
• Study Completion (Estimated): October 26, 2023

Study Registration Dates

• First Submitted: November 17, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pulsed radiofrequency; Trigeminal neuralgia; Continuous radiofrequency; High-voltage pulsed radiofrequency combined with low-temperature continuous radiofrequency
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: KY-2019-266-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No