Pulsed Radiofrequency in Treatment of Classic Trigeminal Neuralgia (Prolonged Duration Versus Higher Voltage)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trigeminal Neuralgia
- Sponsor
- Mansoura University
- Enrollment
- 60
- Primary Endpoint
- Pain amplitude reduction
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Time Frame: 1 year
compare the pain amplitude reduction in the three groups using the visual analogue pain scale
Secondary Outcomes
- RAND 36-Item Health Survey(1 year)