Trigeminal neuralgia is a very painful condition, and radiofrequency therapy is reserved for patients who are resistant or intolerant to pharmacological therapy. Continuous radiofrequency and pulsed radiofrequency both have advantages and disadvantages. Recently, studies have found that pulsed radiofrequency combined with low-temperature (\<65 °C) continuous radiofrequency increases the efficacy of the treatment, without leading to a significant increase in complications caused by nerve lesions. However, these reports have some limitations. The investigators plan to conduct a randomized, controlled study to compare the efficacy of applying high-voltage pulsed radiofrequency, with and without low-temperature continuous radiofrequency, to the gasserian ganglion for the treatment of trigeminal neuralgia. The primary outcome will be the effectiveness of the treatment after 12 months which is the percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score between I-III.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
2 Hz of pulsed radiofrequency will be administered at a voltage of 70 V, temperature of 42 °C, pulse width of 20 ms, and treatment time of 600 s.
Low-temperature continuous radiofrequency will be performed at 60 °C, with a treatment time of 270 s.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
The percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score of I-III
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) will be used to evaluate the efficacy of the treatment. Twelve months after the procedure, participants with Barrow Neurological Institute scores of I-III will be defined as having received effective treatment. The primary outcome will be the effectiveness of the treatment after 12 months.
Time frame: Twelve months after the procedure
The modified Barrow Neurological Institute Pain Intensity Score
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) will be used to evaluate the efficacy of the treatment.
Time frame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Numeric rating scale
Pain was assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Time frame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Dose of carbamazepine or oxcarbazepine
Dose of carbamazepine or oxcarbazepine per day (mg/day)
Time frame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Patient satisfaction scores on the 5-point Likert scale
1: poor, 2: fair, 3: good, 4: very good, 5: excellent
Time frame: After 1, 6 and 12 months following the procedure
The World Health Organization Quality of Life (WHOQOL)-BREF
Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale.
Time frame: After 1, 6 and 12 months following the procedure
Numbness
The Barrow Neurological Institute facial numbness scores (I: No facial numbness; II: Mild facial numbness, not bothersome; III: Facial Numbness, somewhat bothersome; IV: Facial numbness, very bothersome) will be used to evaluate the facial numbness.
Time frame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
Number of participants with anesthesia dolorosa
The participant's facial sensation decreased, accompanied by pain
Time frame: Within 12 months of the procedure
Number of participants with masticator weakness
Occlusal dysfunction or a lower degree of masseter muscle fullness on one side when biting hard.
Time frame: Within 12 months of the procedure
Number of participants with corneal anesthesia
When touching the sclera with a cotton swab hair does not cause the eyelids to close quickly.
Time frame: Within 12 months of the procedure
Number of participants with keratitis
Eye dryness and pain, photophobia, lacrimation, excess mucus and other conditions diagnosed as keratitis by an ophthalmologist
Time frame: Within 12 months of the procedure
Number of participants with adverse reactions
Nausea, vomiting, and facial hematoma during and after the procedure; headache, dizziness, and cerebrospinal fluid leakage occurring within two weeks of the procedure.
Time frame: Within two weeks of the procedure
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