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临床试验/NCT06278194
NCT06278194招募中不适用

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

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Masseter muscle thickness

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pain refractory to medical therapy for at least 3 months
  • Planning radiofrequency thermocoagulation of gasserian ganglion
  • Accept ultrasound measurements to be performed

排除标准

  • Refused to participate in the study
  • Not attending follow-ups regularly
  • Coagulation disorder
  • Pregnancy
  • Localized or systemic infection

研究组 & 干预措施

Patients treated with gasserian ganglion RFT for trigeminal neuralgia

Other

In patients who have undergone radiofrequency thermocoagulation (RFT) of the gasserian ganglion for the treatment of trigeminal neuralgia, the thickness of the masseter muscle will be measured bilaterally, free and contracted, by ultrasound on the day of the procedure (just before the procedure) and at 1 and 3 months after the procedure.

干预措施: Gasserian Ganglion Radiofrequency Thermocoagulation (Procedure)

结局指标

主要结局

Masseter muscle thickness

时间窗: Post-procedural third month

The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.

次要结局

未报告次要终点

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Burak Erken

Medical doctor

Başakşehir Çam & Sakura City Hospital

研究点 (1)

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