Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia
NCT ID: NCT06684275
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2024-11-10
2025-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions it aims to answer are:
* Does PRF or PRF + TRF provide better pain relief for patients with trigeminal neuralgia?
* What is the safety profile and complication rate of PRF versus PRF + TRF?
Researchers will compare the effects of PRF and PRF + TRF to see if thermal lesioning in addition to pulsed RF provides superior long-term pain relief and reduces the need for analgesic medication.
Participants will:
* Undergo either PRF or PRF + TRF treatment targeting the trigeminal nerve.
* Be assessed for pain relief, functional status, and adverse events over a 3-month follow-up period.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will enroll participants with TN, randomized into two groups:
* Group 1 (PRF): Patients will receive pulsed radiofrequency treatment with parameters set to standard levels for pain relief.
* Group 2 (PRF + TRF): Patients will receive pulsed radiofrequency combined with thermal lesioning (60-70°C) to target the trigeminal nerve.
Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia. The primary outcome will be pain reduction measured using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS) over a 12-week period. Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III (MQS III) and the recording of procedure-related adverse events.
Participants will undergo follow-up assessments at Week 1, Week 4, and Week 12 post-treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pulsed Radiofrequency (PRF)
Participants in this group will receive pulsed radiofrequency (PRF) treatment targeted to the trigeminal nerve. The procedure will involve a standard PRF protocol.
Pulsed Radiofrequency (PRF)
Participants will receive pulsed radiofrequency (PRF) treatment targeting the trigeminal nerve to manage pain associated with trigeminal neuralgia. This non-ablative technique uses electrical pulses to modulate nerve function, aiming to provide pain relief without creating a thermal lesion.
Pulsed and Thermal Radiofrequency (PRF + TRF)
Participants in this group will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF). The TRF procedure will involve creating a thermal lesion at a target temperature in addition to the standard PRF treatment protocol.
Pulsed and Thermal Radiofrequency (PRF + TRF)
Participants will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF) treatments targeting the trigeminal nerve. This approach combines the non-ablative effects of PRF with the thermal lesioning of TRF to provide long-term pain relief for trigeminal neuralgia.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pulsed Radiofrequency (PRF)
Participants will receive pulsed radiofrequency (PRF) treatment targeting the trigeminal nerve to manage pain associated with trigeminal neuralgia. This non-ablative technique uses electrical pulses to modulate nerve function, aiming to provide pain relief without creating a thermal lesion.
Pulsed and Thermal Radiofrequency (PRF + TRF)
Participants will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF) treatments targeting the trigeminal nerve. This approach combines the non-ablative effects of PRF with the thermal lesioning of TRF to provide long-term pain relief for trigeminal neuralgia.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of classical trigeminal neuralgia, as per the International Classification of Headache Disorders criteria
* Patients experiencing unilateral, episodic facial pain for at least six months with a Numeric Rating Scale (NRS) score greater than 6, despite medical treatment.
* Able to provide informed consent.
* Agree to follow the study procedures and attend follow-up visits.
Exclusion Criteria
* Previous surgery or radiofrequency treatment for trigeminal neuralgia.
* Pregnant or breastfeeding women.
* Known allergies to anesthetics or other agents used in the procedure.
* Significant psychiatric disorders that may interfere with pain assessment or study participation.
* Coagulopathy or use of anticoagulants that contraindicate the procedure.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zagazig University
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Awad Bessar
Assistant Professor of Diagnostic and Interventional Radiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed A Bessar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zagazig University, Faculty of Medicine
Zagazig, Sharqia Province, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ahmed A Bessar, MD, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRF-TRF-TN
Identifier Type: -
Identifier Source: org_study_id