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

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ClinicalTrials.gov Identifier: NCT03131466
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : July 3, 2018
Sponsor:
Collaborators:
Beijing Friendship Hospital
Beijing Ditan Hospital
Information provided by (Responsible Party):
Fang Luo, Beijing Tiantan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Trigeminal Neuralgia Device: High-voltage pulsed radiofrequency Drug: Nerve block Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRF Group
This group will undergo 42°C high-voltage pulsed radiofrequency treatment.
Device: High-voltage pulsed radiofrequency
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.

Active Comparator: Nerve Block Group
This group will undergo nerve block treatment with steroid and local anesthesia.
Drug: Nerve block
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 Outcome Measures :
  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 Outcome Measures :
  1. Patient satisfaction [ Time Frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year 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 and 1 year 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 and 1 year after operation ]
  4. Adverse events [ Time Frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year after opeartion ]
    Data regarding intraoperative and postoperative adverse events.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131466


Contacts
Contact: Fang Luo, M.D. +86 13611326978 13611326978@163.com

Locations
China, Beijing
Beijing Ditan Hospital Recruiting
Beijing, Beijing, China, 100015
Contact: Hao Cheng, M.D.    +86 13801312117    chenghaocn@yahoo.com   
Principal Investigator: Hao Cheng, M.D.         
Beijing Friendship Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Yanping Li, M.D.    +86 13701197818    yanping7391@sina.com   
Principal Investigator: Yanping Li, M.D.         
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Fang Luo, M.D.    +86 13611326978    13211326978@163.com   
Principal Investigator: Fang Luo, M.D.         
Sponsors and Collaborators
Beijing Tiantan Hospital
Beijing Friendship Hospital
Beijing Ditan Hospital
Investigators
Principal Investigator: Fang Luo, M.D. Beijing Tiantan Hospital

Publications:

Responsible Party: Fang Luo, vice director of Department of Anesthesiology and Pain Management, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03131466     History of Changes
Other Study ID Numbers: KY2017-004-01
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fang Luo, Beijing Tiantan Hospital:
Trigeminal Neuralgia
Pulsed Radiofrequency
Gasserian Ganglion

Additional relevant MeSH terms:
Neuralgia
Ganglion Cysts
Trigeminal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases