High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
Primary Purpose
Idiopathic Trigeminal Neuralgia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-voltage pulsed radiofrequency
Nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Trigeminal Neuralgia focused on measuring Trigeminal Neuralgia, Pulsed Radiofrequency, Gasserian Ganglion
Eligibility 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.
Sites / Locations
- Beijing Ditan Hospital
- Beijing Friendship Hospital
- Beijing Tiantan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRF Group
Nerve Block Group
Arm Description
This group will undergo 42°C high-voltage pulsed radiofrequency treatment.
This group will undergo nerve block treatment with steroid and local anesthesia.
Outcomes
Primary Outcome Measures
Effective rate of Primary Trigeminal Neuralgia treatment
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
Patient satisfaction
Patient satisfaction score (PSS) score will be used to evaluate patient satisfaction: 0 point indicates unsatisfactory, while 10 points indicates very satisfactory.
Dosage of adjuvant antiepileptic drugs
Data regarding patients with a BNI of IV or V who switch to other treatments
Adverse events
Data regarding intraoperative and postoperative adverse events.
The postoperative response rate
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%.
Full Information
NCT ID
NCT03131466
First Posted
April 22, 2017
Last Updated
October 24, 2021
Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Friendship Hospital, Beijing Ditan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03131466
Brief Title
High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
Official Title
Effectiveness and Safety of High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
September 3, 2020 (Actual)
Study Completion Date
September 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Friendship Hospital, Beijing Ditan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Trigeminal Neuralgia
Keywords
Trigeminal Neuralgia, Pulsed Radiofrequency, Gasserian Ganglion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRF Group
Arm Type
Experimental
Arm Description
This group will undergo 42°C high-voltage pulsed radiofrequency treatment.
Arm Title
Nerve Block Group
Arm Type
Active Comparator
Arm Description
This group will undergo nerve block treatment with steroid and local anesthesia.
Intervention Type
Device
Intervention Name(s)
High-voltage pulsed radiofrequency
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nerve block
Intervention Description
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 Measure Information:
Title
Effective rate of Primary Trigeminal Neuralgia treatment
Description
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%.
Time Frame
1 year after operation
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction score (PSS) score will be used to evaluate patient satisfaction: 0 point indicates unsatisfactory, while 10 points indicates very satisfactory.
Time Frame
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation
Title
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
Title
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
Title
Adverse events
Description
Data regarding intraoperative and postoperative adverse events.
Time Frame
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion
Title
The postoperative response rate
Description
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%.
Time Frame
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Luo, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24077204
Citation
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.
Results Reference
background
PubMed Identifier
26000688
Citation
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.
Results Reference
background
PubMed Identifier
27676662
Citation
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.
Results Reference
background
PubMed Identifier
20121355
Citation
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.
Results Reference
background
PubMed Identifier
23433058
Citation
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.
Results Reference
background
PubMed Identifier
23322665
Citation
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.
Results Reference
background
PubMed Identifier
24954016
Citation
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.
Results Reference
background
PubMed Identifier
28076964
Citation
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.
Results Reference
background
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High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
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