Pulsed Radiofrequency in Trigeminal Neuralgia

Pulsed Radiofrequency in Treatment of Classic Trigeminal Neuralgia (Prolonged Duration Versus Higher Voltage)

The current study investigated the efficacy of pulsed radiofrequency in pain reduction in TN patients and compared the efficacy and the impact on the quality of life of the standard technique with a prolonged duration technique and a higher voltage one.

Entire enrolled patients were diagnosed as classic TN according to the international headache society classification (IHS, 2013) and underwent brain MRI and MRA to exclude secondary causes. Patients were randomly divided into three groups, Group A patients underwent PRF using the standard settings, group B patients underwent PRF with prolonged duration and Group C patients underwent PRF with higher voltage. VAS and pain amplitude reduction were recorded before the intervention and 1 hour, 1 day, 1week, 1 month, 6 months and 1year after it. Quality of life was assessed before and 1 year after the intervention.

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Procedure: pulsed radiofrequency

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients are diagnosed as classic TN according to the international headache society classification of headache disorders
• Visual analogue scale (VAS) for pain of at least 4 or more.
• Pain is refractory to medical treatment (for at least 3 months with three drugs including carbamazepine with optimum dosage) or patients who developed intolerable side effects from medications.

Exclusion Criteria:

• Symptomatic (secondary) TN: which is causes by structural lesion other than neurovascular compression such as multiple sclerosis, tumors, stroke or trauma according to the international headache society classification (IHS, 2013).

Local infection at the site of the needle puncture. Bleeding tendency or coagulopathy. Previous treatment with invasive treatments such as radiofrequency thermo coagulation, destructive chemical injection, gamma knife treatment, percutaneous balloon micro-compression or microvascular decompression.

Major mental or psychiatric disorders. History of drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; using the standard settings of pulsed radiofrequency technique (PRFT). two cycles, each one for 2 minutes at 45 Volts (V) with a pulse width of 10 milliseconds (ms) and a pulse frequency of 4 Hertz (Hz). The cut-off needle tip temperature is set at 420 Celsius (C).	Procedure: pulsed radiofrequency; Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device
Experimental: Group B; using prolonged duration of PRFT. four cycles, each one for 2 minutes at 45V with a pulse width of 10ms and a pulse frequency of 4Hz. The cut-off needle tip temperature is set at 420C.	Procedure: pulsed radiofrequency; Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device
Experimental: Group C; using higher voltage PRFT.. two cycles, each one for 2 minutes at 60V with a pulse width of 10ms and a pulse frequency of 4Hz. The cut-off needle tip temperature is set at 420C.	Procedure: pulsed radiofrequency; Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain amplitude reduction	compare the pain amplitude reduction in the three groups using the visual analogue pain scale	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RAND 36-Item Health Survey	compare the quality of life changes before and after intervention using RAND 36-Item Health Survey	1 year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: December 1, 2019
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: pulsed 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: MD/16.06.26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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