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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05516888
Other study ID # 138/14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 25, 2022
Est. completion date August 25, 2023

Study information

Verified date September 2023
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the efficacy of radiofrequency of the Gasserian ganglion versus peripheral branches of the trigeminal nerve for the treatment of trigeminal neuralgia.


Description:

Trigeminal neuralgia (TN) is defined as sudden, severe, short-term, stabbing and recurrent pain in the distribution of one or more branches of the trigeminal nerve. Many invasive treatments are available for patients who respond poorly to medical therapy. Among them, radiofrequency therapy is a viable option with a reliable initial and long-term clinical efficacy.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 25, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders. - Suffering from severe trigeminal neuralgia that cannot be alleviated effectively with conservative therapy. - Agree to participate in the study Exclusion Criteria: - Infection at the puncture site. - Coagulation disorder. - Abnormal blood test (hepatic or renal function) - History of receiving invasive treatment (glycerol rhizolysis, radiofrequency thermocoagulation, balloon compression, gamma knife treatment, microvascular decompression)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
radiofrequency of gasserian ganglion
radiofrequency ablation of the gasserian ganglion
radiofrequency of the peripheral trigeminal branches
radiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital)

Locations

Country Name City State
Turkey Diskapi Yildirim Beyazit Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The modified Barrow Neurological Institute Pain Intensity Score The efficacy of the treatment will be assessed using the modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief). six months
Secondary Numeric rating scale Pain will evaluated by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable). baseline to six months
Secondary Patient satisfaction Patient satisfaction scores on the 5-point Likert scale (1: poor, 2: fair, 3: good, 4: very good, 5: excellent) six months
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