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Completed

NCT Number: NCT04174443

The Efficacy and Safety of Pulsed Radiofrequency Combined With Continuous Radiofrequency for the Trigeminal Neuralgia

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.

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd Edition criteria.
  • Aged 18-75 years (inclusive), no sex limitation.
  • Suffering from severe trigeminal neuralgia that cannot be alleviated effectively using conservative medical therapy such as carbamazepine, oxcarbazepine.
  • Numeric rating scale score≥7 before the procedure.
  • Agreed to sign the informed consent form.

Exclusion criteria

  • Secondary trigeminal neuralgia such as trigeminal neuralgia attributed to a space-occupying lesion or multiple sclerosis.
  • Infection at the puncture site.
  • A history of psychiatric disease.
  • Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest X-ray.
  • Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (II-III of the New York Heart Association classification).
  • A history of abuse of narcotics.
  • A history of receiving continuous radiofrequency to the gasserian ganglion or peripheral branches; glycerol rhizolysis; balloon compression; gamma knife; or any other neuroablative treatments.
  • A history of receiving microvascular decompression.

Treatment and study plan

High-voltage pulsed radiofrequency

Procedure

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

Procedure

Low-temperature continuous radiofrequency will be performed at 60 °C, with a treatment time of 270 s.

Primary outcomes

  1. The percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score of I-III

    Time frame: Twelve months after the procedure

    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.

Secondary outcomes

  1. The modified Barrow Neurological Institute Pain Intensity Score

    Time frame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure

    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.

  2. Numeric rating scale

    Time frame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure

    Pain was assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).

  3. Dose of carbamazepine or oxcarbazepine

    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 per day (mg/day)

  4. Patient satisfaction scores on the 5-point Likert scale

    Time frame: After 1, 6 and 12 months following the procedure

    1: poor, 2: fair, 3: good, 4: very good, 5: excellent

  5. The World Health Organization Quality of Life (WHOQOL)-BREF

    Time frame: After 1, 6 and 12 months following the procedure

    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.

  6. Numbness

    Time frame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure

    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.

  7. Number of participants with anesthesia dolorosa

    Time frame: Within 12 months of the procedure

    The participant's facial sensation decreased, accompanied by pain

  8. Number of participants with masticator weakness

    Time frame: Within 12 months of the procedure

    Occlusal dysfunction or a lower degree of masseter muscle fullness on one side when biting hard.

  9. Number of participants with corneal anesthesia

    Time frame: Within 12 months of the procedure

    When touching the sclera with a cotton swab hair does not cause the eyelids to close quickly.

  10. Number of participants with keratitis

    Time frame: Within 12 months of the procedure

    Eye dryness and pain, photophobia, lacrimation, excess mucus and other conditions diagnosed as keratitis by an ophthalmologist

  11. Number of participants with adverse reactions

    Time frame: Within two weeks of the procedure

    Nausea, vomiting, and facial hematoma during and after the procedure; headache, dizziness, and cerebrospinal fluid leakage occurring within two weeks of the procedure.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia

Acronym: PRFCRF

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2019
Registry last updated
Aug 6, 2024

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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