Trials Sponsors Conditions Drugs Pricing

Conditions

Idiopathic Trigeminal Neuralgia

Keywords

Trigeminal NeuralgiaPulsed RadiofrequencyGasserian Ganglion

Outcome Measures

Primary Outcomes (1)

Effective rate of Primary Trigeminal Neuralgia treatment
The Barrow Neurological Institute (BNI) pain intensity score will be used to assess pain degree. Pain relief degree will be evaluated as "excellent" (BNI pain score I-II), "good" (BNI pain score III), and "poor" (BNI pain score IV-V). The effective rate=excellent and good pain relief (BNI I - III)/total number of cases \* 100%.
1 year after operation

Secondary Outcomes (5)

Patient satisfaction
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
Dosage of adjuvant antiepileptic drugs
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
Data regarding patients with a BNI of IV or V who switch to other treatments
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
Adverse events
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion
The postoperative response rate
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion

Study Arms (2)

PRF Group

EXPERIMENTAL

This group will undergo 42°C high-voltage pulsed radiofrequency treatment.

Device: High-voltage pulsed radiofrequency

Nerve Block Group

ACTIVE COMPARATOR

This group will undergo nerve block treatment with steroid and local anesthesia.

Drug: Nerve block

Interventions

High-voltage pulsed radiofrequencyDevice

The manual PRF mode of the pain treatment generator will be turned on, the upper temperature limit will be set at 42°C, the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the patient will be treated for 360 s. After the treatment, 1.4 ml of a mixture of 0.4 mL of normal saline and 1 mL of 1% plain lidocaine will be injected through the needle of the cannula, and before the needle being removed, 0.5 mL of normal saline will be injected.

PRF Group

Nerve blockDrug

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
years old.

Sponsors & Collaborators

Beijing Friendship Hospital
Othercollaborator
Beijing Ditan Hospital
Othercollaborator
Beijing Tiantan Hospital

Study Sites (3)

Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Related Publications (9)

Nader A, Kendall MC, De Oliveria GS, Chen JQ, Vanderby B, Rosenow JM, Bendok BR. Ultrasound-guided trigeminal nerve block via the pterygopalatine fossa: an effective treatment for trigeminal neuralgia and atypical facial pain. Pain Physician. 2013 Sep-Oct;16(5):E537-45.
PMID: 24077204BACKGROUND
Nader A, Bendok BR, Prine JJ, Kendall MC. Ultrasound-Guided Pulsed Radiofrequency Application via the Pterygopalatine Fossa: A Practical Approach to Treat Refractory Trigeminal Neuralgia. Pain Physician. 2015 May-Jun;18(3):E411-5.
PMID: 26000688BACKGROUND

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

Fang Luo, M.D.
Beijing Tiantan Hospital
PRINCIPAL INVESTIGATOR

Enrollment

134 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: vice director of Department of Anesthesiology and Pain Management

Study Record Dates

First Submitted

April 22, 2017

First Posted

April 27, 2017

Study Start

April 28, 2017

Actual (reported)

High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

PRF Group

Nerve Block Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

PRF Group

Nerve Block Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations