Comparison of the Efficacy of Trigeminal Ganglion Radiofrequency Thermocoagulation and Ultrasound-guided Maxillary-mandibular Pulsed Radiofrequency in the Treatment of Trigeminal Neuralgia
Sponsor study identifier
interventional
44
1 country
1
Study Start
January 11, 2023
Actual (reported)Primary Completion
February 4, 2024
Actual (reported)Study Completion
March 7, 2024
Actual (reported)Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 7, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 11, 2023
Actual (reported)February 4, 2024
Actual (reported)March 7, 2024
Actual (reported)April 10, 2024
Actual (reported)April 15, 2024
Actual (reported)Numerical rating scale (NRS)
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Change from baseline to 1st and 6th month after treatment
The Medication Quantification Scale III (MQS III)
Change from baseline 6th month after treatment
Trigeminal ganglion radiofrequency thermocoagulation for trigeminal neuralgia
Maxillary mandibular nerve pulsed radiofrequency for trigeminal neuralgia
The patient is placed in the supine position and the foramen ovale is identified medial to the coronoid process of the mandible by giving the head a submental oblique position under fluoroscopic guidance. A 20-gauge, 5 mm active type, and 100 mm radiofrequency cannula is inserted 2 cm lateral to the commissura labialis and advanced towards the foramen. After entering the foramen ovale with a lateral fluoroscopic image, the radiofrequency cannula is connected to the radiofrequency generator and sensory and motor stimulations are performed to confirm the target maxillary and mandibular nerves. The radiofrequency lesion is applied at 60°C, 65°C and 70°C for 60-seconds periods. The patient is observed for side effects for 1 hour after the procedure.
Diskapi Training and Research Hospital
Ankara, Turkey (Türkiye)
Gevher Rabia Genc Perdecioğlu
Diskapi TRH
44 participants (actual enrollment reported by the registry).
First Submitted
April 10, 2024
First Posted
April 15, 2024
Study Start
January 11, 2023
Actual (reported)The patient is placed in the lateral decubitus position with the affected side up. A 5-12 MHz linear ultrasound probe is placed in the infrazygomatic area above the maxilla at a 45° inclination in both the frontal and horizontal planes. The probe position allows visualization of the pterygopalatine fossa, which is limited to the maxilla anteriorly and the greater wing of the sphenoid posteriorly. Real-time ultrasound guidance allows direct localization of the internal maxillary artery and identification of the needle tip. The radiofrequency cannula was connected to the radiofrequency generator and PRF was applied at 42°C for 240 seconds after confirming the localization of the maxillary and mandibular nerve by obtaining appropriate responses to sensory and motor stimulation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 4, 2024
Actual (reported)Study Completion
March 7, 2024
Actual (reported)Last Updated
April 15, 2024
Record last verified: 2024-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: