Pulsed Radiofrequency in Trigeminal Neuralgia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Pain amplitude reduction [1 year]
compare the pain amplitude reduction in the three groups using the visual analogue pain scale
Secondary Outcome Measures
- RAND 36-Item Health Survey [1 year]
compare the quality of life changes before and after intervention using RAND 36-Item Health Survey
Eligibility Criteria
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.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mansoura University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MD/16.06.26