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

Primary Purpose

Trigeminal Neuralgia

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-voltage pulsed radiofrequency
Low-temperature continuous radiofrequency
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Trigeminal neuralgia, Pulsed radiofrequency, Continuous radiofrequency, High-voltage pulsed radiofrequency combined with low-temperature continuous radiofrequency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulsed radiofrequency + Continuous radiofrequency

Pulsed radiofrequency

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2019
Last Updated
July 20, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04174443
Brief Title
The Efficacy and Safety of Pulsed Radiofrequency Combined With Continuous Radiofrequency for the Trigeminal Neuralgia
Acronym
PRFCRF
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
October 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia
Keywords
Trigeminal neuralgia, Pulsed radiofrequency, Continuous radiofrequency, High-voltage pulsed radiofrequency combined with low-temperature continuous radiofrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsed radiofrequency + Continuous radiofrequency
Arm Type
Experimental
Arm Title
Pulsed radiofrequency
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
High-voltage pulsed radiofrequency
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low-temperature continuous radiofrequency
Intervention Description
Low-temperature continuous radiofrequency will be performed at 60 °C, with a treatment time of 270 s.
Primary Outcome Measure Information:
Title
The percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score of I-III
Description
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.
Time Frame
Twelve months after the procedure
Secondary Outcome Measure Information:
Title
The modified Barrow Neurological Institute Pain Intensity Score
Description
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.
Time Frame
On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Title
Numeric rating scale
Description
Pain was assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Time Frame
On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Title
Dose of carbamazepine or oxcarbazepine
Description
Dose of carbamazepine or oxcarbazepine per day (mg/day)
Time Frame
On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Title
Patient satisfaction scores on the 5-point Likert scale
Description
1: poor, 2: fair, 3: good, 4: very good, 5: excellent
Time Frame
After 1, 6 and 12 months following the procedure
Title
The World Health Organization Quality of Life (WHOQOL)-BREF
Description
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.
Time Frame
After 1, 6 and 12 months following the procedure
Title
Numbness
Description
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.
Time Frame
On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Title
Number of participants with anesthesia dolorosa
Description
The participant's facial sensation decreased, accompanied by pain
Time Frame
Within 12 months of the procedure
Title
Number of participants with masticator weakness
Description
Occlusal dysfunction or a lower degree of masseter muscle fullness on one side when biting hard.
Time Frame
Within 12 months of the procedure
Title
Number of participants with corneal anesthesia
Description
When touching the sclera with a cotton swab hair does not cause the eyelids to close quickly.
Time Frame
Within 12 months of the procedure
Title
Number of participants with keratitis
Description
Eye dryness and pain, photophobia, lacrimation, excess mucus and other conditions diagnosed as keratitis by an ophthalmologist
Time Frame
Within 12 months of the procedure
Title
Number of participants with adverse reactions
Description
Nausea, vomiting, and facial hematoma during and after the procedure; headache, dizziness, and cerebrospinal fluid leakage occurring within two weeks of the procedure.
Time Frame
Within two weeks of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Luo, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
33400432
Citation
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.
Results Reference
derived

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

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