Clinical trial NCT06492213: The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia
Official title: Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infraorbital Neuralgia
Platelet-rich Plasma
Keywords: Infraorbital neuralgia; platelet- rich plasma
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
name: Qinghai People's Hospital
First posted: 2024-07-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 to 75 years;
2. 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;
3. NRS score≥7;
4. Scheduled for PRF treatment for IONa；
5. Signed informed consent.

Exclusion Criteria:

1. Platelet count \<105\*109/L, ongoing anticoagulation therapy or antiplatelets treatment, coagulation disorders or bleeding disorders;
2. Severe cardiopulmonary or hepatorenal dysfunction;
3. Infection at the puncture site; .
4. Neuralgia secondary to tissue damage around the infraorbital foramen from causes such as maxillary sinusitis or tumor;
5. History of destructive treatments such as radiofrequency thermocoagulation, chemical ablation, infraorbital neurectomy, infraorbital nerve avulsion, etc;
6. History of mental disorders；
7. History of narcotic drug abuse;
8. Unable to cooperation.

Primary outcomes:
measure: The 1-year response rate
timeFrame: 12-month period
Secondary outcomes:
measure: Response rate
timeFrame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
measure: Dosage of carbamazepine
timeFrame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
measure: Numeric rating scale (NRS) score of pain
timeFrame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
measure: Patients' quality of life (QOL)
timeFrame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
measure: Patient satisfaction scores (PSS）
timeFrame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
measure: Adverse events (AEs)
timeFrame: at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fang Luo
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Luo Fang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: