The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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；
Disqualifiers
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;
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No interventions
Other interventionIt is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: PRP+PRF1 intervention
Group B: PRF alone1 intervention
Trial outcomes
Primary outcomes
1
The 1-year response rate
cases responding to treatment/total number of cases\*100%
Time frame
12-month periodSecondary outcomes
1
Response rate
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 operation2
Dosage of carbamazepine
dosage of carbamazepine
Time frame
at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation3
Numeric rating scale (NRS) score of pain
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 operation4
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')
Time frame
at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tiantan Hospital
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Qinghai People's Hospital
Collaborator
Source ClinicalTrials.gov