Pulsed Radiofrequency in Trigeminal Neuralgia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04355221

Enrollment

Registered

2020-04-21

Start date

2016-07-31

Completion date

2019-07-31

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia

Keywords

pulsed radiofrequency

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.

Interventions

PROCEDUREpulsed radiofrequency

Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pain amplitude reduction	1 year	compare the pain amplitude reduction in the three groups using the visual analogue pain scale

Secondary

Measure	Time frame	Description
RAND 36-Item Health Survey	1 year	compare the quality of life changes before and after intervention using RAND 36-Item Health Survey

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026