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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06278194
Other study ID # 22.11.2023.589
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 15, 2024
Est. completion date November 15, 2024

Study information

Verified date February 2024
Source Basaksehir Cam & Sakura Sehir Hospital
Contact Burak Erken, MD
Phone +0902129096000
Email burak_erken@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve. The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure. In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date November 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria: - Pain refractory to medical therapy for at least 3 months - Planning radiofrequency thermocoagulation of gasserian ganglion - Accept ultrasound measurements to be performed Exclusion Criteria: - Refused to participate in the study - Not attending follow-ups regularly - Coagulation disorder - Pregnancy - Localized or systemic infection

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Gasserian Ganglion Radiofrequency Thermocoagulation
Gasserian ganglion radiofrequency thermocoagulation is performed in the operating room under fluoroscopy. In sterile condition, the foramen ovale is shown by the pain management specialist under fluoroscopy guidance. After this condition, the entry of the needle is marked and anaesthetised with local anaesthetic. After the entry of the gasserian ganglion with the radiofrequency needle, 10 cm long, the location is checked with sensory and motor stimulation. If the placement is correct, 70 degrees 70 seconds of radiofrequency thermocoagulation is applied.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Basaksehir Cam & Sakura Sehir Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Masseter muscle thickness The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed. Pre-procedural time
Primary Masseter muscle thickness The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed. Post-procedural first month
Primary Masseter muscle thickness The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed. Post-procedural third month
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