Efficacy and Safety of Irregular Pulsed Radiofrequency (Sluijter-Teixera Poisson) Versus Regular Pulsed Radiofrequency to the Gasserian Ganglion for Treatment of Primary Trigeminal Neuralgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Irregular pulsed Radiofrequency, Regular pulsed Radiofrequency.
- Who it may be relevant to
- Registry conditions: Trigeminal Neuralgia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to compare between the Efficacy and safety of irregular pulsed radiofrequency STP versus regular pulsed radiofrequency to the gasserian ganglion for treatment of primary trigeminal neuralgia.
Detailed description
Trigeminal neuralgia is a severe pain condition characterized by transient, paroxysmal, electric shock-like pain occurring in areas supplied by the trigeminal nerve. The incidence of trigeminal neuralgia increases with advancing age and has a substantial negative impact on quality of life, often leading to psychological distress.
Pharmacological therapy represents the primary treatment modality for most patients with trigeminal neuralgia. Surgical and interventional procedures, including microvascular decompression, partial sensory rhizotomy, radiofrequency therapy, glycerol rhizolysis, balloon compression, and gamma knife surgery, are generally reserved for patients who are resistant or intolerant to medical treatment. Each of these modalities has specific advantages and limitations, and no single ideal surgical treatment has been established.
Pulsed radiofrequency (PRF) is considered one of the least destructive neuromodulation techniques. It stimulates the gasserian ganglion using pulsed electrical current while maintaining tissue temperature below 42°C. The pulsed current is delivered intermittently, allowing heat dissipation and minimizing neural tissue damage. Patients who respond favorably to PRF often experience significant improvement in pain and quality of life; however, conventional PRF has been associated with limited efficacy and a shorter duration of pain relief compared to continuous radiofrequency techniques.
Several modifications have been introduced to enhance PRF effectiveness, including adjustments in output voltage and pulse delivery parameters. Despite these modifications, achieving an optimal balance between efficacy and safety remains challenging.
The Slijter-Teixeira Poisson (STP) mode of pulsed radiofrequency utilizes a Poisson distribution pattern for energy delivery, allowing pulses to be more evenly and precisely distributed. This approach aims to optimize therapeutic outcomes while minimizing heat generation and tissue injury. The STP mode provides shorter pulse widths and a higher coefficient of variance, which may enhance treatment effectiveness without increasing neurodestructive effects.
Accordingly, this study is designed to compare the efficacy and safety of regular pulsed radiofrequency and STP-mode pulsed radiofrequency applied to the gasserian ganglion in patients with primary trigeminal neuralgia.
Interventions
- Procedure Irregular pulsed Radiofrequency
irregular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia - Procedure Regular pulsed Radiofrequency
Regular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia
Primary outcome measures
- change in pain intensity [Time frame: day 1 after 1 and 2 weeks, and after 1, 2, 3 and 6 months following the procedure]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of primary trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
- Age between 18 and 75 years
- Severe trigeminal neuralgia not adequately relieved by conservative medical therapy, including carbamazepine or oxcarbazepine
- Numeric Rating Scale (NRS-11) pain score of 7 or higher prior to the procedure
- Ability and willingness to provide written informed consent
Exclusion criteria
- Secondary trigeminal neuralgia, including trigeminal neuralgia attributed to space-occupying lesions or multiple sclerosis
- Infection at the puncture site
- History of psychiatric disease
- Clinically significant abnormalities in routine laboratory tests, including hepatic, renal, or coagulation function, or abnormalities on electrocardiogram or chest X-ray
- Serious systemic diseases, including uncontrolled hypertension or diabetes mellitus, or cardiac dysfunction classified as New York Heart Association class II-III
- History of narcotic substance abuse
- Previous treatment with continuous radiofrequency to the gasserian ganglion or peripheral branches, glycerol rhizolysis, balloon compression, gamma knife surgery, or other neuroablative procedures
- Previous microvascular decompression
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07275229 · soh-Med-25-11-4MD