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NCT Number: NCT03131466

High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia

The study is designed to compare the effectiveness and safety of high-voltage Pulsed radiofrequency and nerve block for the treatment of primary Trigeminal Neuralgia patients with ineffective conservative treatment and explore better non-surgical treatment methods for Trigeminal Neuralgia patients.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Ditan Hospital, Beijing, Beijing Municipality, China

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About this study

Trigeminal neuralgia (TN) is a paroxysmal, lightning-like, severe pain in the facial area innervated by trigeminal nerve. Patients who have failed to achieve benefits from drug treatment could try to undergo nerve block, a traditional conservative treatment. Pulsed radiofrequency (PRF) is a noninvasive pain intervention technique for the treatment of TN. However, its treatment effectiveness has rarely been reported and remains controversial among scholars. A recent single-center preliminary clinical study showed that high-voltage PRF had significant effectiveness in the treatment of TN. However, whether high-voltage PRF treatment can become an optional treatment for TN patients who have failed to achieve benefits from drug treatment still needs to be confirmed with standardized clinical studies by utilizing conservative nerve block treatment as a control. The study is designed to compare the effectiveness and safety of high-voltage PRF and nerve block for the treatment of primary TN patients with ineffective conservative treatment and explore better non-surgical treatment methods for TN patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
  • 18-75 years old.
  • Response to drug treatment poorly or unable to tolerate the side effects of drugs.
  • A BNI pain intensity scale score of IV-V.
  • Supposed to undergo neurosurgical intervention according to Trigeminal Neuralgia treatment guidelines.
  • Agree to participate in this trial and have signed the informed consent.

Exclusion criteria

  • Abnormal routine blood, liver or kidney functions, abnormal blood biochemistry test, or coagulation disorders.
  • Abnormal electrocardiogram or chest X-ray results.
  • Severe cardiopulmonary dysfunction.
  • Infection at the puncture site.
  • History of mental illness, or history of narcotic drug abuse.
  • Allergy to local anesthetic drugs or steroids.
  • Cannot cooperate with the treatment.
  • History of invasive treatments, such as radiofrequency thermocoagulation, chemical ablation, balloon compression surgery, gamma knife treatment, peripheral denervation or microvascular decompression.

Treatment and study plan

High-voltage pulsed radiofrequency

Device

The manual PRF mode of the pain treatment generator will be turned on, the upper temperature limit will be set at 42°C, the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the patient will be treated for 360 s. After the treatment, 1.4 ml of a mixture of 0.4 mL of normal saline and 1 mL of 1% plain lidocaine will be injected through the needle of the cannula, and before the needle being removed, 0.5 mL of normal saline will be injected.

Nerve block

Drug

The radiofrequency generator will be set at the sensory stimulating mode, and the lowest frequency of 0.2 V will be used for 360s-sham PRF treatment, after which 1.4 mL of a mixture of 2 mg of dexamethasone sodium phosphate and 1 mL of 1% plain lidocaine will be slowly injected through the radiofrequency treatment cannula needle. Before the needle being removed, 0.5 mL of normal saline will be injected.

Primary outcomes

  1. Effective rate of Primary Trigeminal Neuralgia treatment

    Time frame: 1 year after operation

    The Barrow Neurological Institute (BNI) pain intensity score will be used to assess pain degree. Pain relief degree will be evaluated as "excellent" (BNI pain score I-II), "good" (BNI pain score III), and "poor" (BNI pain score IV-V). The effective rate=excellent and good pain relief (BNI I - III)/total number of cases * 100%.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation

    Patient satisfaction score (PSS) score will be used to evaluate patient satisfaction: 0 point indicates unsatisfactory, while 10 points indicates very satisfactory.

  2. Dosage of adjuvant antiepileptic drugs

    Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation

  3. Data regarding patients with a BNI of IV or V who switch to other treatments

    Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation

  4. Adverse events

    Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion

    Data regarding intraoperative and postoperative adverse events.

  5. The postoperative response rate

    Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion

    The Barrow Neurological Institute (BNI) pain intensity score will be used to assess pain degree. Pain relief degree will be evaluated as "excellent" (BNI pain score I-II), "good" (BNI pain score III), and "poor" (BNI pain score IV-V). The effective rate=excellent and good pain relief (BNI I - III)/total number of cases * 100%.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Ditan Hospital
  • Beijing Friendship Hospital

Registry information

Official study title

Effectiveness and Safety of High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 27, 2017
Registry last updated
Oct 26, 2021

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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