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NCT Number: NCT06278194

Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

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.

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Gasserian Ganglion; Lesion Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gasserian Ganglion Radiofrequency Thermocoagulation

Procedure

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.

Primary outcomes

  1. Masseter muscle thickness

    Time frame: Pre-procedural time

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

  2. Masseter muscle thickness

    Time frame: Post-procedural first month

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

  3. Masseter muscle thickness

    Time frame: Post-procedural third month

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

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Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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