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| Name | Class |
|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Qinghai People's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions | Other | It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone. |
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| Measure | Description | Time Frame |
|---|---|---|
| The 1-year response rate | cases responding to treatment/total number of cases*100% | 12-month period |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | cases responding to treatment/total number of cases*100% | at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation |
| Dosage of carbamazepine | dosage of carbamazepine |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Liu, M.D. | Contact | +8618618418228 | emmaliulu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Luo Fang, M.D. | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fang Luo | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| 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 | 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') | 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 | 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 | at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment. |