Pulsed Radiofrequency in Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355221
• Other study ID #: MD/16.06.26
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: April 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Procedure:
• pulsed radiofrequency
Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain amplitude reduction	compare the pain amplitude reduction in the three groups using the visual analogue pain scale	1 year
Secondary	RAND 36-Item Health Survey	compare the quality of life changes before and after intervention using RAND 36-Item Health Survey	1 year