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Evaluation of radiofrequency efficacy for the treatment of refractory trigeminal neuralgia

Percutaneous radiofrequency over sham procedure for the treatment of refractory trigeminal neuralgia (THE PROVE STUDY): a double-blind, randomized study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3w29vx
Enrollment
Unknown
Registered
2020-03-27
Start date
2020-01-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

trigeminal neuralgia

Interventions

Group 1: Percutaneous radiofrequency ablation of the trigeminal We'll carry out one trigeminal radiofrequency in 20 patients in group 1, The definition of the branches to be ablated will be made cli
Procedure/surgery
D26.660

Sponsors

Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
45 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients over 18 years old Diagnosis of classic or idiopathic trigeminal neuralgia rigeminal neuropathic pain refractory to clinical treatment for at least 6 months.

Exclusion criteria

Exclusion criteria: Patients under 45 years old Patient refusal Mandatory use of anticoagulants or antiplatelet agents, except AAS. Presence of local or systemic infection Psychiatric diseases that impair the assessment of the effectiveness of the procedure.

Design outcomes

Primary

MeasureTime frame
50% pain decrease in the first 12 months, measured by analogic verbal scale

Secondary

MeasureTime frame
Life quality improvement in the first 12 months, measured by SF-36 ;Anticonvulsant dose decreasein the first 12 monthscompared to the baseline

Countries

Brazil

Contacts

Public ContactAndre Mansano

Faculdade de Medicina da Universidade de São Paulo

andremarquesmansano@gmail.com+5511986537000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)