]>
IRCT20260623069925N1 IRCT 2026-06-26 Tehran University of Medical Sciences Comparison of Two Radiofrequency Techniques for the Treatment of Drug-Resistant Trigeminal Neuralgia PCRF-TN Comparison of the Effectiveness of Conventional Radiofrequency Versus Combined Pulsed-Conventional Radiofrequency in the Treatment of Drug-Resistant Trigeminal Neuralgia: A Randomized Clinical Trial 2026-07-23 anticipated 28 Recruiting https://irct.ir/trial/91105 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants who provide written informed consent will be randomly allocated in a 1:1 ratio to the Conventional Radiofrequency group or the Pulsed Radiofrequency plus Conventional Radiofrequency group using block randomization. The random allocation sequence will be generated using statistical software, and allocation concealment will be ensured by sequentially numbered, opaque, sealed envelopes, Blinding description: This study is a single-blind randomized clinical trial. Participants will be blinded to the allocated intervention (Conventional Radiofrequency or Pulsed Radiofrequency combined with Conventional Radiofrequency). Outcome assessors responsible for data collection and clinical outcome assessment will also be blinded to treatment allocation. The physician performing the procedure (investigator) will not be blinded because of the nature of the intervention. Clinical care providers and data analysts will also not be blinded. N/A Trigeminal Neuralgia. Intervention 1: Control group: Participants will undergo conventional radiofrequency (CRF) treatment of the trigeminal nerve. After fluoroscopic needle placement and confirmation by sensory and motor stimulation, conventional radiofrequency will be applied at 70°C for 60 seconds in three consecutive cycles using a four-channel NeuroTherm radiofrequency generator (NeuroTherm, USA). Intervention 2: Intervention group:Participants will undergo pulsed radiofrequency (PRF) at a maximum temperature of 42°C for 240 seconds (20-ms pulse width, 2 Hz), followed immediately by conventional radiofrequency (CRF) at 70°C for 60 seconds in two consecutive cycles using a four-channel NeuroTherm radiofrequency generator (NeuroTherm, USA). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is A final decision regarding sharing de-identified individual participant data has not yet been made. Data sharing will be determined after study completion according to journal and institutional policies.
public Asma Amiri
No. 8, Golparvar Alley, Mousavi St., Shahrara Neighborhood, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445753955 +98 21 8826 8180 asma.amirid@gmail.com Tehran University of Medical Sciences scientific Reza Atef Yekta
Pain Medicine Department, Dr. Shariati Hospital, North Kargar St., Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 atefyekta@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18 to 80 years Diagnosis of classical trigeminal neuralgia according to ICHD-3 criteria Positive response to diagnostic block with at least 50% reduction in pain intensity based on the NRS ASA physical status I or II Ability to understand the study and sign the informed consent form Failure to respond adequately to standard two-drug or three-drug therapy 18 years 80 years Both Refusal to participate in the study or failure to provide informed consent Secondary trigeminal neuralgia due to multiple sclerosis or tumor lesions Coagulation disorders or use of anticoagulant drugs that cannot be discontinued Active local or systemic infection Known allergy to lidocaine or dexamethasone History of open trigeminal surgery or previous radiofrequency procedures Unstable cardiopulmonary disease Pregnancy or breastfeeding G50.0 Trigeminal neuralgia Treatment - Devices Treatment - Devices Control group: Participants will undergo conventional radiofrequency (CRF) treatment of the trigeminal nerve. After fluoroscopic needle placement and confirmation by sensory and motor stimulation, conventional radiofrequency will be applied at 70°C for 60 seconds in three consecutive cycles using a four-channel NeuroTherm radiofrequency generator (NeuroTherm, USA). Intervention group:Participants will undergo pulsed radiofrequency (PRF) at a maximum temperature of 42°C for 240 seconds (20-ms pulse width, 2 Hz), followed immediately by conventional radiofrequency (CRF) at 70°C for 60 seconds in two consecutive cycles using a four-channel NeuroTherm radiofrequency generator (NeuroTherm, USA). Pain intensity measured by the Numerical Rating Scale (NRS). Timepoint: Pain intensity will be measured at baseline, before the intervention, and then 1 month and 3 months after the intervention. Method of measurement: Pain intensity will be measured using the Numerical Rating Scale (NRS), scored from 0 to 10. Quality of life measured by the 36-Item Short Form Health Survey (SF-36). Timepoint: Before the intervention, 1 month after the intervention, and 3 months after the intervention. Method of measurement: Quality of life will be measured using the 36-Item Short Form Health Survey (SF-36). Incidence of intervention-related adverse events. Timepoint: Before the intervention, 1 month after the intervention, and 3 months after the intervention. Method of measurement: Adverse events will be assessed by clinical examination, patient interview, and documentation of all intervention-related adverse events, including facial numbness, dysesthesia, masticatory muscle weakness, decreased corneal reflex, and other potential complications. Tehran University of Medical Sciences Approved 2026-06-24 Research Ethics Committee of Neuroscience Institute, Tehran University of Medical Sciences No. 8, Unit 4, Golparvar Alley, Mousavi St., Shahrara Neighborhood, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)