Evaluating masseter muscle thickness after nerve treatment for trigeminal neuralgia
Change of the Masseter Muscle Thickness Measured by Ultrasonography After Gasser Ganglion Radiofrequency Thermocoagulation Treatment
This study is testing whether a specific nerve treatment for trigeminal neuralgia can change the thickness of the masseter muscle in patients who haven't found relief from other medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Başakşehir Çam & Sakura City Hospital Government |
| Locations | 1 site (Istanbul, Başakşehir) |
| Trial ID | NCT06278194 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Gasserian ganglion radiofrequency thermocoagulation on the masseter muscle thickness in patients suffering from trigeminal neuralgia. The procedure aims to alleviate pain by ablating the affected trigeminal nerve branch, which may also impact the masseter muscle due to its innervation. Patients who have not responded to medical therapy for at least three months and are scheduled for this treatment will undergo ultrasound measurements to assess changes in muscle thickness. The study seeks to understand the potential functional effects of the procedure on the masseter muscle.
Who should consider this trial
Good fit: Ideal candidates are patients with trigeminal neuralgia who have not responded to medical therapy for at least three months and are planning to undergo radiofrequency thermocoagulation.
Not a fit: Patients with coagulation disorders, pregnancy, or those who refuse to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the functional impact of nerve ablation on muscle health, potentially improving patient outcomes in trigeminal neuralgia treatment.
How similar studies have performed: While there have been studies on radiofrequency treatments for trigeminal neuralgia, the specific focus on masseter muscle thickness is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul, Başakşehir
- Başakşehir Çam and Sakura City Hospital — Istanbul, Başakşehir, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Tuba Tanyel Saraçoğlu, MD — Başakşehir Çam & Sakura City Hospital
- Study coordinator: Burak Erken, MD
- Email: burak_erken@hotmail.com
- Phone: +0902129096000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.