Fang Luo
Beijing, Beijing Municipality, 100070, China
Location status: Recruiting
NCT Number: NCT06492213
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Beijing, Beijing Municipality, 100070, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.
Time frame: 12-month period
cases responding to treatment/total number of cases*100%
Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
cases responding to treatment/total number of cases*100%
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
0 representing no pain and 10 representing the most severe pain imaginable
Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
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')
Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
0 point indicates unsatisfactory, while 10 points indicate the most satisfactory
Time frame: at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.
such as dizziness, facial swelling, facial ecchymoma, eye injury, infection, etc
Contact information is provided by the study sponsor or research team.
Beijing Tiantan Hospital
Other
Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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