Pulsed Radiofrequency in Trigeminal Neuralgia

Mansoura University60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Trigeminal Neuralgia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain amplitude reduction

compare the pain amplitude reduction in the three groups using the visual analogue pain scale

Time frame: 1 year

Secondary Outcomes

RAND 36-Item Health Survey

compare the quality of life changes before and after intervention using RAND 36-Item Health Survey

Time frame: 1 year