Trigeminal Neuralgia, IdiopathicNCT06472323
The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for the Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia, Idiopathic and PRP, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Trigeminal neuralgia (TN), characterized by brief, recurrent paroxysms of lancinating pain in the distribution of 1 or more branches of the trigeminal nerve (fifth cranial nerve [CNV]), is one of the most common, severe forms of neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trigeminal Neuralgia, Idiopathic, PRP
- What is being tested?
- PRF+PRP, PRF
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The main purpose of this study will be to compare the effectiveness of PRF combined with and without PRP, evaluated 1 year after the procedure. The effectiveness of PRF combined PRP group after 1 year is supposed to be 90%, and that of the high-voltage PRF group was 69% (29) (The α is 0.05, and the power is 90%). Power Analysis and Sample Size (PASS) V.15.0 software (NCSS Corporation, Kaysville, UT, USA) was used to compute the sample size. The results show that 73 patients will be required in each group. However, Accounting for 10% loss to follow-up and an additional 40% loss after propensity score matching, 135 patients will be recruited in each group. Therefore the total sample size of this study is supposed to be 270 participants.
Who may be able to join
- The diagnosis of TN was established according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria (1).
- Aged 18 to 75 years.
- Had a score of at least 4 on a Numeric Rating Scale (NRS-11) (NRS; range, 0-10; higher scores indicate more severe pain) and could't be alleviated effectively by means of conservative medical therapy, such as carbamazepine, oxcarbazepine.
- Agreed to sign the informed consent form.
Who cannot join
- Patients presenting classic TN or secondary TN (i.e., multiple sclerosis).
- Infection at the site of needle entry or systemic infecting.
- 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 (New York Heart Association grade II-III).
- A history of abuse of narcotics.
Show all 9Show fewer
- A history of receiving CRF to the Gasserian ganglion or peripheral branches, glycerol rhizolysis, balloon compression, Gamma knife, or any other neuroablative treatments.
- A history of receiving microvascular decompression.
- Use of anticoagulants or antiplatelet agent, eg. acetylsalicylic acid.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University in Beijing
Beijing, Beijing Municipality
Fang Luo, (86) 010 59976664, 13611326978@163.com
About this study
Official title: The Efficacy and Safety of Pulsed Radiofrequency(PRF) Combined With Platelet-rich Plasma Versus PRF Alone for the Trigeminal Neuralgia
Trigeminal neuralgia (TN), characterized by brief, recurrent paroxysms of lancinating pain in the distribution of 1 or more branches of the trigeminal nerve (fifth cranial nerve [CNV]), is one of the most common, severe forms of neuropathic pain. Current standard of care for TN is the sodium channel blockers such as carbamazepine or oxcarbazepine. Surgical treatments involve percutaneous procedures, stereotactic radiosurgery and open surgical treatment. Each of these treatments have drawback. In recent years, pulsed radiofrequency (PRF) has been shown to be a promising treatment option for TN. But it was reported that the long-term outcomes of PRF was not satisfactory. Thus, there is an overwhelming need for finding a safe, nondestructive treatment option that is more effective for TN. PRP releases a variety of bioactive factors and adhesion proteins, which are responsible for activating hemostatic cascade reaction, synthesizing new connective tissue and vascular reconstruction, to initiate tissue repair processes. Autologous platelet-rich plasma (PRP) is the processed liquid fraction of autologous peripheral blood with a platelet concentration above the baseline. Studies have shown that it can reduce inflammation and promote nerve repair so it has also shown broad prospects in treating neuropathic pain. In 2012, Doss AX. published a case report indicated that PRP might be effective in TN treatment. In 2023, a randomized controlled study showed that CT-guided PRF combined with PRP can effectively treat postherpetic neuralgia (PHN), and the therapeutic effect is better than that of traditional PRF combined with glucocorticoid therapy in patients with PHN, which is similar to TN in pathology. Thus, we suppose that PRF combined with PRP might show better effectiveness than PRF alone for TN and conducted a prospective trail comparing the clinical efficacy and safety of PRP combined with PRF versus PRF alone. This study is designed as a prospective cohort study, open-label study with a 12 months follow-up period, to compare the efficacy of PRF combined with PRP versus PRP alone for TN treatment.
- Conditions
- Trigeminal Neuralgia, Idiopathic, PRP
- Being tested
- PRF+PRP, PRF
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF+PRP, PRFProcedure or surgery
Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion of the patient. After puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. After removing the RF electrode in the combined treatment group, 2ml of LP-PRP mixture was injected slowly into the Gasserian ganglion and mandibular nerve and PRF group only receive PRF treatment.
| Study group | Role | What they receive |
|---|---|---|
| PRF+PRP | The puncture point was located 3cm outside the corners of the mouth of the affected side, using the Hartel technique. Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion. After accurately puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. After removing the RF electrode in the combined treatment group, 2 ml of LP-PRP mixture was injected slowly into the Gasserian ganglion and mandibular nerve. Receives: Procedure: PRF+PRP, PRF | |
| PRF | The puncture point was located 3cm outside the corners of the mouth of the affected side, using the Hartel technique. Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion. After accurately puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. Receives: Procedure: PRF+PRP, PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate of treatment
Patients with BNI scores of I to III were considered to respond to treatment (Table 2).
Measured: After 12 months
Secondary outcomes (4)
BNI scores
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
Measured: day 1; after 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
The response rate of treatment
The response rate of treatment
Measured: 1day, 1 and 2 weeks, 1, 2, 3, and 6 months following the procedure
Anticonvulsant consumption
Dose of carbamazepine or oxcarbazepine
Measured: After 1 day, 1 and 2 weeks, and after 1, 2, 3, 6, and 12 months following the procedure
Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
Measured: After 1, 3, 6, and 12 months following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Trigeminal Neuralgia, IdiopathicStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472323
- Sponsor's protocol ID
- KY2023-263-03-1
- Status last verified
- Mar 2025
- First submitted
- 10 Jun 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ren H, Zhao C, Wang X, Shen Y, Meng L, Luo F. 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: Study Protocol for a Prospective, Open-Label, Parall. Pain Physician. 2021 Jan;24(1):89-97.
PubMed 33400432Jia Y, Cheng H, Shrestha N, Ren H, Zhao C, Feng K, Luo F. Effectiveness and safety of high-voltage pulsed radiofrequency to treat patients with primary trigeminal neuralgia: a multicenter, randomized, double-blind, controlled study. J Headache Pain. 2023 Jul 18;24(1):91. doi: 10.1186/s10194-023-01629-7.
PubMed 37464283Luo F, Wang T, Shen Y, Meng L, Lu J, Ji N. High Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study. Pain Physician. 2017 May;20(4):271-279.
PubMed 28535550Chong MS, Bahra A, Zakrzewska JM. Guidelines for the management of trigeminal neuralgia. Cleve Clin J Med. 2023 Jun 1;90(6):355-362. doi: 10.3949/ccjm.90a.22052.
PubMed 37263669Bendtsen L, Zakrzewska JM, Heinskou TB, Hodaie M, Leal PRL, Nurmikko T, Obermann M, Cruccu G, Maarbjerg S. Advances in diagnosis, classification, pathophysiology, and management of trigeminal neuralgia. Lancet Neurol. 2020 Sep;19(9):784-796. doi: 10.1016/S1474-4422(20)30233-7.
PubMed 32822636Fan X, Fu Z, Ma K, Tao W, Huang B, Guo G, Huang D, Liu G, Song W, Song T, Xiao L, Xia L, Liu Y. Chinese expert consensus on minimally invasive interventional treatment of trigeminal neuralgia. Front Mol Neurosci. 2022 Jul 28;15:953765. doi: 10.3389/fnmol.2022.953765. eCollection 2022.
PubMed 35966020Abd-Elsayed A, Martens JM, Fiala KJ, Izuogu A. Pulsed Radiofrequency for the Treatment of Trigeminal Neuralgia. Curr Pain Headache Rep. 2022 Dec;26(12):889-894. doi: 10.1007/s11916-022-01092-0. Epub 2022 Nov 15.
PubMed 36378398Luo 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.
PubMed 23322665Chua NH, Halim W, Beems T, Vissers KC. Pulsed radiofrequency treatment for trigeminal neuralgia. Anesth Pain Med. 2012 Spring;1(4):257-61. doi: 10.5812/aapm.3493. Epub 2012 Apr 1.
PubMed 24904811Zipu J, Hao R, Chunmei Z, Lan M, Ying S, Fang L. Long-term Follow-up of Pulsed Radiofrequency Treatment for Trigeminal Neuralgia: Kaplan-Meier Analysis in a Consecutive Series of 149 Patients. Pain Physician. 2021 Dec;24(8):E1263-E1271.
PubMed 34793653Agarwal A, Rastogi S, Bansal M, Kumar S, Malviya D, Thacker AK. Radiofrequency Treatment of Idiopathic Trigeminal Neuralgia (Conventional vs. Pulsed): A Prospective Randomized Control Study. Anesth Essays Res. 2021 Jan-Mar;15(1):14-19. doi: 10.4103/aer.aer_56_21. Epub 2021 Aug 30.
PubMed 34667342Everts P, Onishi K, Jayaram P, Lana JF, Mautner K. Platelet-Rich Plasma: New Performance Understandings and Therapeutic Considerations in 2020. Int J Mol Sci. 2020 Oct 21;21(20):7794. doi: 10.3390/ijms21207794.
PubMed 33096812Gupta S, Paliczak A, Delgado D. Evidence-based indications of platelet-rich plasma therapy. Expert Rev Hematol. 2021 Jan;14(1):97-108. doi: 10.1080/17474086.2021.1860002. Epub 2020 Dec 17.
PubMed 33275468Hassanien M, Elawamy A, Kamel EZ, Khalifa WA, Abolfadl GM, Roushdy ASI, El Zohne RA, Makarem YS. Perineural Platelet-Rich Plasma for Diabetic Neuropathic Pain, Could It Make a Difference? Pain Med. 2020 Apr 1;21(4):757-765. doi: 10.1093/pm/pnz140.
PubMed 31298289Zhou Z, Hu X, Yan F, Zhou Y, He R, Ye X, Jiang Z. Observation on the effect of platelet-rich plasma combined with drugs in the treatment of herpes zoster neuralgia. Int J Neurosci. 2024 Jun;134(6):628-634. doi: 10.1080/00207454.2022.2138381. Epub 2022 Nov 2.
PubMed 36259487
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pulsed Radiofrequency(PRF) Combined With Platelet-rich Plasma Versus PRF Alone for the Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT06472323
- Acronym / sponsor ID
- KY2023-263-03-1
- Conditions
- Trigeminal Neuralgia, Idiopathic, PRP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trigeminal neuralgia (TN), characterized by brief, recurrent paroxysms of lancinating pain in the distribution of 1 or more branches of the trigeminal nerve (fifth cranial nerve [CNV]), is one of the most common, severe forms of neuropathic pain. Current standard of care for TN is the sodium channel blockers such as carbamazepine or oxcarbazepine. Surgical treatments involve percutaneous procedures, stereotactic radiosurgery and open surgical treatment. Each of these treatments have drawback. In recent years, pulsed radiofrequency (PRF) has been shown to be a promising treatment option for TN. But it was reported that the long-term outcomes of PRF was not satisfactory. Thus, there is an overwhelming need for finding a safe, nondestructive treatment option that is more effective for TN. PRP releases a variety of bioactive factors and adhesion proteins, which are responsible for activating hemostatic cascade reaction, synthesizing new connective tissue and vascular reconstruction, to initiate tissue repair processes. Autologous platelet-rich plasma (PRP) is the processed liquid fraction of autologous peripheral blood with a platelet concentration above the baseline. Studies have shown that it can reduce inflammation and promote nerve repair so it has also shown broad prospects in treating neuropathic pain. In 2012, Doss AX. published a case report indicated that PRP might be effective in TN treatment. In 2023, a randomized controlled study showed that CT-guided PRF combined with PRP can effectively treat postherpetic neuralgia (PHN), and the therapeutic effect is better than that of traditional PRF combined with glucocorticoid therapy in patients with PHN, which is similar to TN in pathology. Thus, we suppose that PRF combined with PRP might show better effectiveness than PRF alone for TN and conducted a prospective trail comparing the clinical efficacy and safety of PRP combined with PRF versus PRF alone. This study is designed as a prospective cohort study, open-label study with a 12 months follow-up period, to compare the efficacy of PRF combined with PRP versus PRP alone for TN treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF+PRP | – | Procedure: PRF+PRP, PRFThe puncture point was located 3cm outside the corners of the mouth of the affected side, using the Hartel technique. Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion. After accurately puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. After removing the RF electrode in the combined treatment group, 2 ml of LP-PRP mixture was injected slowly into the Gasserian ganglion and mandibular nerve. |
| PRF | – | Procedure: PRF+PRP, PRFThe puncture point was located 3cm outside the corners of the mouth of the affected side, using the Hartel technique. Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion. After accurately puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The main purpose of this study will be to compare the effectiveness of PRF combined with and without PRP, evaluated 1 year after the procedure. The effectiveness of PRF combined PRP group after 1 year is supposed to be 90%, and that of the high-voltage PRF group was 69% (29) (The α is 0.05, and the power is 90%). Power Analysis and Sample Size (PASS) V.15.0 software (NCSS Corporation, Kaysville, UT, USA) was used to compute the sample size. The results show that 73 patients will be required in each group. However, Accounting for 10% loss to follow-up and an additional 40% loss after propensity score matching, 135 patients will be recruited in each group. Therefore the total sample size of this study is supposed to be 270 participants.
Key inclusion criteria (4 listed)
- The diagnosis of TN was established according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria (1).
- Aged 18 to 75 years.
- Had a score of at least 4 on a Numeric Rating Scale (NRS-11) (NRS; range, 0-10; higher scores indicate more severe pain) and could't be alleviated effectively by means of conservative medical therapy, such as carbamazepine, oxcarbazepine.
- Agreed to sign the informed consent form.
Key exclusion criteria (9 listed)
- Patients presenting classic TN or secondary TN (i.e., multiple sclerosis).
- Infection at the site of needle entry or systemic infecting.
- 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 (New York Heart Association grade II-III).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRF+PRP, PRFUnder CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion of the patient. After puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. After removing the RF electrode in the combined treatment group, 2ml of LP-PRP mixture was injected slowly into the Gasserian ganglion and mandibular nerve and PRF group only receive PRF treatment. | Procedure or surgery | PRF, PRF+PRP |
Primary outcome
The response rate of treatment
Time frame: After 12 months
Patients with BNI scores of I to III were considered to respond to treatment (Table 2).
4 secondary outcomes
BNI scores
Time frame: day 1; after 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
The response rate of treatment
Time frame: 1day, 1 and 2 weeks, 1, 2, 3, and 6 months following the procedure
Anticonvulsant consumption
Time frame: After 1 day, 1 and 2 weeks, and after 1, 2, 3, 6, and 12 months following the procedure
Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
Time frame: After 1, 3, 6, and 12 months following the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 33400432Ren H, Zhao C, Wang X, Shen Y, Meng L, Luo F. 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: Study Protocol for a Prospective, Open-Label, Parall. Pain Physician. 2021 Jan;24(1):89-97.
- Background: PubMed 37464283Jia Y, Cheng H, Shrestha N, Ren H, Zhao C, Feng K, Luo F. Effectiveness and safety of high-voltage pulsed radiofrequency to treat patients with primary trigeminal neuralgia: a multicenter, randomized, double-blind, controlled study. J Headache Pain. 2023 Jul 18;24(1):91. doi: 10.1186/s10194-023-01629-7.
- Background: PubMed 28535550Luo F, Wang T, Shen Y, Meng L, Lu J, Ji N. High Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study. Pain Physician. 2017 May;20(4):271-279.
- Background: PubMed 37263669Chong MS, Bahra A, Zakrzewska JM. Guidelines for the management of trigeminal neuralgia. Cleve Clin J Med. 2023 Jun 1;90(6):355-362. doi: 10.3949/ccjm.90a.22052.
- Background: PubMed 32822636Bendtsen L, Zakrzewska JM, Heinskou TB, Hodaie M, Leal PRL, Nurmikko T, Obermann M, Cruccu G, Maarbjerg S. Advances in diagnosis, classification, pathophysiology, and management of trigeminal neuralgia. Lancet Neurol. 2020 Sep;19(9):784-796. doi: 10.1016/S1474-4422(20)30233-7.
- Background: PubMed 35966020Fan X, Fu Z, Ma K, Tao W, Huang B, Guo G, Huang D, Liu G, Song W, Song T, Xiao L, Xia L, Liu Y. Chinese expert consensus on minimally invasive interventional treatment of trigeminal neuralgia. Front Mol Neurosci. 2022 Jul 28;15:953765. doi: 10.3389/fnmol.2022.953765. eCollection 2022.
- Background: PubMed 36378398Abd-Elsayed A, Martens JM, Fiala KJ, Izuogu A. Pulsed Radiofrequency for the Treatment of Trigeminal Neuralgia. Curr Pain Headache Rep. 2022 Dec;26(12):889-894. doi: 10.1007/s11916-022-01092-0. Epub 2022 Nov 15.
- Background: PubMed 23322665Luo 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.
- Background: PubMed 24904811Chua NH, Halim W, Beems T, Vissers KC. Pulsed radiofrequency treatment for trigeminal neuralgia. Anesth Pain Med. 2012 Spring;1(4):257-61. doi: 10.5812/aapm.3493. Epub 2012 Apr 1.
- Background: PubMed 34793653Zipu J, Hao R, Chunmei Z, Lan M, Ying S, Fang L. Long-term Follow-up of Pulsed Radiofrequency Treatment for Trigeminal Neuralgia: Kaplan-Meier Analysis in a Consecutive Series of 149 Patients. Pain Physician. 2021 Dec;24(8):E1263-E1271.
- Background: PubMed 34667342Agarwal A, Rastogi S, Bansal M, Kumar S, Malviya D, Thacker AK. Radiofrequency Treatment of Idiopathic Trigeminal Neuralgia (Conventional vs. Pulsed): A Prospective Randomized Control Study. Anesth Essays Res. 2021 Jan-Mar;15(1):14-19. doi: 10.4103/aer.aer_56_21. Epub 2021 Aug 30.
- Background: PubMed 33096812Everts P, Onishi K, Jayaram P, Lana JF, Mautner K. Platelet-Rich Plasma: New Performance Understandings and Therapeutic Considerations in 2020. Int J Mol Sci. 2020 Oct 21;21(20):7794. doi: 10.3390/ijms21207794.
- {Doss2012TrigeminalNT, title={Trigeminal Neuralgia Treatment: A Case Report On Short-Term Follow Up After Ultrasound Guided Autologous Platelet Rich Plasma Injections.}, author={Arockia X Doss}, year={2012}Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beijing Tiantan Hospital, Capital Medical University in Beijing
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, Idiopathic and PRP, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate of treatment (time frame: After 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06472323, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.