Open AccessHigh Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study
Author(s) -
Nan Ji
Publication year - 2017
Publication title -
pain physician
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.31
H-Index - 99
eISSN - 2150-1149
pISSN - 1533-3159
DOI - 10.36076/ppj.2017.279
Subject(s) - medicine , pulsed radiofrequency , refractory (planetary science) , infraorbital nerve , neuralgia , anesthesia , trigeminal neuralgia , maxillary nerve , randomized controlled trial , adverse effect , prospective cohort study , surgery , neuropathic pain , pain relief , physics , alternative medicine , pathology , astrobiology
Background: A recent study showed that 50% of patients who suffered from refractory neuralgiaof the infraorbital nerve obtained satisfactory efficacy after pulsed radiofrequency (PRF) treatment.A pilot study showed that increasing the output voltage of PRF significantly improved the efficacyfor trigeminal neuralgia; however, whether increasing the output voltage of PRF can improve thetreatment outcomes for neuralgia of the infraorbital nerve is unknown.Objective: To evaluate the efficacy and safety of high voltage PRF treatment in comparison withstandard voltage PRF for neuralgia of the infraorbital nerve.Study Design: Prospective, single-center, double-blinded, randomized, controlled trial.Setting: Beijing Tiantan Hospital, Capital Medical University.Methods: A total of 60 patients with refractory neuralgia of the infraorbital nerve were randomlydivided into the high voltage PRF group and the standard voltage PRF group to treat theirinfraorbital nerves. Neither the patients, pain physicians, nor the follow-up evaluators knew thepatient group assignments. The primary outcome measure was the one-year response rate. Thesecondary outcome measures included the time to take effect after PRF, the one-month, 3-month,and 6-month response rates, the relapse rate, and adverse reactions.Results: The intent-to-treat analysis showed that the one-month, 3-month, 6-month, and oneyear response rates were all 90% in the high voltage group, which were significantly higher thanthe rates in the standard voltage group (67% [P < 0.05], 67% [P < 0.05], 63% [P < 0.05], and 60%[P <0.01], respectively). Furthermore, 27% of the patients in the high-voltage group and 13% ofthe patients in the standard voltage group experienced minor transient (10 – 30 days) numbnessin the innervation area after PRF; no other serious adverse reactions were observed in the 2 groups(P > 0.05).Limitations: We did not investigate the dose-effect relationship between the output voltage andefficacy or the effect of a higher pulse dose on efficacy. This study was a single-center study, andmulti-center, randomized, controlled studies are needed to obtain the highest level of empiricalevidence. Additionally, the follow-up period lasted only one year in this study; thus, long-termefficacy needs to be further confirmed.Conclusions: The results showed that high voltage PRF was effective and safe for patients withrefractory neuralgia of the infraorbital nerve and could become a treatment option in patients whodo not respond to conservative treatment.Key words: Neuralgia, infraorbital nerve, pulsed radiofrequency, numeric rating scales, treatment