Pulsed Radiofrequency in Trigeminal Neuralgia

Study Overview
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Brief Summary
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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.

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

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Procedure: pulsed radiofrequency


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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<br>* Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device<br>|
| Experimental: Group B<br>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<br>* Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device<br>|
| Experimental: Group C<br>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<br>* Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulsed radiofrequency