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Completed

NCT Number: NCT04355221

Pulsed Radiofrequency in Trigeminal Neuralgia

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.

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pulsed radiofrequency

Procedure

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

Primary outcomes

  1. Pain amplitude reduction

    Time frame: 1 year

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

Secondary outcomes

  1. RAND 36-Item Health Survey

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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