Infraorbital NeuralgiaNCT06492213
The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia
An observational study of Infraorbital Neuralgia and Platelet-rich Plasma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of PRP injections combined with PRF treatment with PRF alone in patients with IONa who are responded poorly to conventional therapies and are reluctant to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Infraorbital Neuralgia, Platelet-rich Plasma
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Jul 2027
- 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: Power Analysis and Sample Size (PASS) V.15.0 software (NCSS Corporation, Kaysville, UT, USA) is used to compute the sample size. The results indicate that a study with a power of 80% and two-sided statistical significance level (alpha) of 0.05 would require 64 participants each group. Considering 10% loss to follow-up and an additional 40% loss after propensity score matching, the total sample size of this study will be 237 patients. And we are planning to enroll 240 patients totally considering the convenience of sample collection and statistics
Who may be able to join
- Age between 18 to 75 years;
- Paroxysmal or persistent stabbing pain in the distribution area of the infraorbital nerve and positive response to diagnostic block (1 ml of 2% lidocaine) prior to treatment;
- NRS score≥7;
- Scheduled for PRF treatment for IONa；
- Signed informed consent.
Who cannot join
- Platelet count <105*109/L, ongoing anticoagulation therapy or antiplatelets treatment, coagulation disorders or bleeding disorders;
- Severe cardiopulmonary or hepatorenal dysfunction;
- Infection at the puncture site; .
- Neuralgia secondary to tissue damage around the infraorbital foramen from causes such as maxillary sinusitis or tumor;
- History of destructive treatments such as radiofrequency thermocoagulation, chemical ablation, infraorbital neurectomy, infraorbital nerve avulsion, etc;
- History of mental disorders；
- History of narcotic drug abuse;
- Unable to cooperation.
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
Fang Luo
Beijing, Beijing Municipality, 100070
Fang Luo, 59976661, 13611326978@163.com
Lu Liu, M.D.
About this study
Official title: Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia
This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of PRP injections combined with PRF treatment with PRF alone in patients with IONa who are responded poorly to conventional therapies and are reluctant to receive destructive therapies for seeking a better minimally invasive treatment strategy.
Read the detailed description
Infraorbital neuralgia (IONa) is one of a rare but devastating type of facial pain and lack of current consensus on the management. Previously, we have proved the efficacy of pulsed radiofrequency (PRF) in treatment of IONa. However, refractory patients have not received more ideal treatment until now. Platelet-rich plasma (PRP), as supraphysiological concentration of platelets, can provide prolonged neuropathic pain relief with almost no complications. To date, the efficacy of PRP combined with PRF in the treatment of IONa has not yet been proved. We will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of PRP combined with PRF in treating refractory IONa patients who were reluctant to receive destructive therapies.
- Conditions
- Infraorbital Neuralgia, Platelet-rich Plasma
- Being tested
- No interventions
- Keywords
- Infraorbital neuralgia; platelet- rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.
| Study group | Role | What they receive |
|---|---|---|
| PRP+PRF | PRF procedure will be performed at first. Puncture point will be identified at the surface projection point of the infraorbital foramen on the affected side, and after reach the infraorbital foramen under the guidance of thin-slice CT (2 mm/layer, Somaton, Siemens Company, Munich, Germany). The radiofrequency electrode needle (PMK-21-100; Baylis Medical Inc.) will be inserted into the trocar after removal of the the stylet and confirmation of no bleeding or air when withdrawal using a syringe. The standard PRF mode will be initially set at 42℃, then the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the treatment will be continued for 360 seconds. After PRF, the PRF electrode needle will be removed and 2 milliliter PRP will be injected into the same puncture site through the trocar needle. Receives: Other: No interventions | |
| PRF alone | Puncture point will be identified at the surface projection point of the infraorbital foramen on the affected side, and after reach the infraorbital foramen under the guidance of thin-slice CT (2 mm/layer, Somaton, Siemens Company, Munich, Germany). The radiofrequency electrode needle (PMK-21-100; Baylis Medical Inc.) will be inserted into the trocar after removal of the the stylet and confirmation of no bleeding or air when withdrawal using a syringe. The standard PRF mode will be initially set at 42℃, then the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the treatment will be continued for 360 seconds. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 1-year response rate
cases responding to treatment/total number of cases*100%
Measured: 12-month period
Secondary outcomes (6)
Response rate
cases responding to treatment/total number of cases*100%
Measured: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Dosage of carbamazepine
dosage of carbamazepine
Measured: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Numeric rating scale (NRS) score of pain
0 representing no pain and 10 representing the most severe pain imaginable
Measured: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Patients' quality of life (QOL)
evaluated by 12-item short-form health survey (SF-12) scores,Response categories vary from 2 to 6 and can be transformed to scale scores ranging from 0 ('the worst') to 100 ('the best')
Measured: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Patient satisfaction scores (PSS）
0 point indicates unsatisfactory, while 10 points indicate the most satisfactory
Measured: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Adverse events (AEs)
such as dizziness, facial swelling, facial ecchymoma, eye injury, infection, etc
Measured: at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infraorbital NeuralgiaStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Qinghai People's Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Luo Fang, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492213
- Sponsor's protocol ID
- KY2023-263-03-03
- Status last verified
- Feb 2025
- First submitted
- 1 Jul 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia
- ClinicalTrials.gov ID
- NCT06492213
- Acronym / sponsor ID
- KY2023-263-03-03
- Conditions
- Infraorbital Neuralgia, Platelet-rich Plasma
- Keywords
- Infraorbital neuralgia; platelet- rich plasma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Qinghai People's Hospital
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 9 Jul 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.
This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of PRP injections combined with PRF treatment with PRF alone in patients with IONa who are responded poorly to conventional therapies and are reluctant to receive destructive therapies for seeking a better minimally invasive treatment strategy.
Detailed description
Infraorbital neuralgia (IONa) is one of a rare but devastating type of facial pain and lack of current consensus on the management. Previously, we have proved the efficacy of pulsed radiofrequency (PRF) in treatment of IONa. However, refractory patients have not received more ideal treatment until now. Platelet-rich plasma (PRP), as supraphysiological concentration of platelets, can provide prolonged neuropathic pain relief with almost no complications. To date, the efficacy of PRP combined with PRF in the treatment of IONa has not yet been proved. We will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of PRP combined with PRF in treating refractory IONa patients who were reluctant to receive destructive therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP+PRF | – | Other: No interventionsPRF procedure will be performed at first. Puncture point will be identified at the surface projection point of the infraorbital foramen on the affected side, and after reach the infraorbital foramen under the guidance of thin-slice CT (2 mm/layer, Somaton, Siemens Company, Munich, Germany). The radiofrequency electrode needle (PMK-21-100; Baylis Medical Inc.) will be inserted into the trocar after removal of the the stylet and confirmation of no bleeding or air when withdrawal using a syringe. The standard PRF mode will be initially set at 42℃, then the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the treatment will be continued for 360 seconds. After PRF, the PRF electrode needle will be removed and 2 milliliter PRP will be injected into the same puncture site through the trocar needle. |
| PRF alone | – | Other: No interventionsPuncture point will be identified at the surface projection point of the infraorbital foramen on the affected side, and after reach the infraorbital foramen under the guidance of thin-slice CT (2 mm/layer, Somaton, Siemens Company, Munich, Germany). The radiofrequency electrode needle (PMK-21-100; Baylis Medical Inc.) will be inserted into the trocar after removal of the the stylet and confirmation of no bleeding or air when withdrawal using a syringe. The standard PRF mode will be initially set at 42℃, then the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the treatment will be continued for 360 seconds. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Power Analysis and Sample Size (PASS) V.15.0 software (NCSS Corporation, Kaysville, UT, USA) is used to compute the sample size. The results indicate that a study with a power of 80% and two-sided statistical significance level (alpha) of 0.05 would require 64 participants each group. Considering 10% loss to follow-up and an additional 40% loss after propensity score matching, the total sample size of this study will be 237 patients. And we are planning to enroll 240 patients totally considering the convenience of sample collection and statistics
Key inclusion criteria (5 listed)
- Age between 18 to 75 years;
- Paroxysmal or persistent stabbing pain in the distribution area of the infraorbital nerve and positive response to diagnostic block (1 ml of 2% lidocaine) prior to treatment;
- NRS score≥7;
- Scheduled for PRF treatment for IONa；
- Signed informed consent.
Key exclusion criteria (8 listed)
- Platelet count <105*109/L, ongoing anticoagulation therapy or antiplatelets treatment, coagulation disorders or bleeding disorders;
- Severe cardiopulmonary or hepatorenal dysfunction;
- Infection at the puncture site; .
- Neuralgia secondary to tissue damage around the infraorbital foramen from causes such as maxillary sinusitis or tumor;
- History of destructive treatments such as radiofrequency thermocoagulation, chemical ablation, infraorbital neurectomy, infraorbital nerve avulsion, etc;
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 |
|---|---|---|
| No interventionsIt is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone. | Other | PRF alone, PRP+PRF |
Primary outcome
The 1-year response rate
Time frame: 12-month period
cases responding to treatment/total number of cases*100%
6 secondary outcomes
Response rate
Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Dosage of carbamazepine
Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Numeric rating scale (NRS) score of pain
Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Patients' quality of life (QOL)
Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Patient satisfaction scores (PSS）
Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Adverse events (AEs)
Time frame: at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.
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 21 Feb 2025.
- Individual participant dataSharing planned: No. not yet decided
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.
Luo Fang, M.D. principal investigator
Beijing Tiantan Hospital
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 Infraorbital Neuralgia and Platelet-rich Plasma, 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 5 inclusion and 8 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 21 Feb 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?
Contact Lu Liu, M.D. (+8618618418228, emmaliulu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 1-year response rate (time frame: 12-month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2025.