- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03131466
High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
October 24, 2021 updated by: Fang Luo, Beijing Tiantan Hospital
Effectiveness and Safety of 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
134
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100050
- Beijing Friendship Hospital
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Beijing, Beijing, China, 100050
- Beijing Tiantan Hospital
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Beijing, Beijing, China, 100015
- Beijing Ditan Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PRF Group
This group will undergo 42°C high-voltage pulsed radiofrequency treatment.
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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.
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Active Comparator: Nerve Block Group
This group will undergo nerve block treatment with steroid and local anesthesia.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective rate of Primary Trigeminal Neuralgia treatment
Time Frame: 1 year after operation
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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%.
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1 year after operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
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Patient satisfaction score (PSS) score will be used to evaluate patient satisfaction: 0 point indicates unsatisfactory, while 10 points indicates very satisfactory.
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
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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
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
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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
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
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Adverse events
Time Frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion
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Data regarding intraoperative and postoperative adverse events.
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion
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The postoperative response rate
Time Frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion
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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%.
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nader A, Kendall MC, De Oliveria GS, Chen JQ, Vanderby B, Rosenow JM, Bendok BR. Ultrasound-guided trigeminal nerve block via the pterygopalatine fossa: an effective treatment for trigeminal neuralgia and atypical facial pain. Pain Physician. 2013 Sep-Oct;16(5):E537-45.
- Nader A, Bendok BR, Prine JJ, Kendall MC. Ultrasound-Guided Pulsed Radiofrequency Application via the Pterygopalatine Fossa: A Practical Approach to Treat Refractory Trigeminal Neuralgia. Pain Physician. 2015 May-Jun;18(3):E411-5.
- Elsheikh NA, Amr YM. Calcitonin as an Additive to Local Anesthetic and Steroid Injection Using a Modified Coronoid Approach in Trigeminal Neuralgia. Pain Physician. 2016 Sep-Oct;19(7):457-64.
- Tsou HK, Chao SC, Wang CJ, Chen HT, Shen CC, Lee HT, Tsuei YS. Percutaneous pulsed radiofrequency applied to the L-2 dorsal root ganglion for treatment of chronic low-back pain: 3-year experience. J Neurosurg Spine. 2010 Feb;12(2):190-6. doi: 10.3171/2009.9.SPINE08946.
- Fang L, Ying S, Tao W, Lan M, Xiaotong Y, Nan J. 3D CT-guided pulsed radiofrequency treatment for trigeminal neuralgia. Pain Pract. 2014 Jan;14(1):16-21. doi: 10.1111/papr.12041. Epub 2013 Feb 21.
- Luo F, Meng L, Wang T, Yu X, Shen Y, Ji N. Pulsed radiofrequency treatment for idiopathic trigeminal neuralgia: a retrospective analysis of the causes for ineffective pain relief. Eur J Pain. 2013 Sep;17(8):1189-92. doi: 10.1002/j.1532-2149.2012.00278.x. Epub 2013 Jan 16.
- Fang L, Tao W, Jingjing L, Nan J. Comparison of High-voltage- with Standard-voltage Pulsed Radiofrequency of Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia. Pain Pract. 2015 Sep;15(7):595-603. doi: 10.1111/papr.12227. Epub 2014 Jun 23.
- Maarbjerg S, Di Stefano G, Bendtsen L, Cruccu G. Trigeminal neuralgia - diagnosis and treatment. Cephalalgia. 2017 Jun;37(7):648-657. doi: 10.1177/0333102416687280. Epub 2017 Jan 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2017
Primary Completion (Actual)
September 3, 2020
Study Completion (Actual)
September 3, 2021
Study Registration Dates
First Submitted
April 22, 2017
First Submitted That Met QC Criteria
April 24, 2017
First Posted (Actual)
April 27, 2017
Study Record Updates
Last Update Posted (Actual)
October 26, 2021
Last Update Submitted That Met QC Criteria
October 24, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms
- Pain
- Neurologic Manifestations
- Cysts
- Connective Tissue Diseases
- Neuromuscular Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Peripheral Nervous System Diseases
- Mucinoses
- Cranial Nerve Diseases
- Facial Nerve Diseases
- Trigeminal Nerve Diseases
- Facial Neuralgia
- Neuralgia
- Ganglion Cysts
- Trigeminal Neuralgia
Other Study ID Numbers
- KY2017-004-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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