Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

Trigeminal Neuralgia Clinical Trial

Official title:

Change of the Masseter Muscle Thickness Measured by Ultrasonography After Gasser Ganglion Radiofrequency Thermocoagulation Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06278194
• Other study ID #: 22.11.2023.589
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Ganglion Cysts
• Neuralgia
• Trigeminal Neuralgia

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