Ultrasound guided platelet rich plasma injections for post-traumatic greater occipital neuralgia: a randomized controlled pilot study

Abstract

Background: Post-traumatic headaches (PTH) are a common sequalae of TBI and greatly impact patient function and quality of life. Post-traumatic greater occipital neuralgia (GON) is a type of post-traumatic headache. Conventional treatment includes steroid/anesthetic injections which typically alleviate pain but have a short duration of effect. Platelet rich plasma (PRP) is an emerging biological treatment for numerous degenerative disorders, including peripheral nerve disorders. The primary aim of this pilot study is to evaluate whether a randomized control trial of PRP for the treatment of GON in patients with post-traumatic headaches is feasible in regard to recruitment, adherence, retention, and adherence and adverse events. Exploratory aims includes improvement in pain, function and quality of life in patients with post-traumatic GON receiving PRP compared to steroid/anesthetic and normal saline injections. Methods: Thirty adults (over 18 years of age) with post-traumatic GON will be randomized into one of three groups: 1) autologous PRP injection 2) steroid/anesthetic injection (standard care) or 3) placebo injection with normal saline. Injections will be performed to the greater occipital nerve under ultrasound guidance by a trained physician. Daily headache intensity and frequency data will be collected pre-injection and for the duration of the study period. Feasibility will be defined as greater than 30% recruitment, 70% completion of intervention, 70% retention and less than 2 minor adverse events. Exploratory outcomes will be explored using the (HIT-6; a valid and reliable 6-item questionnaire for assessment of the impact of headaches across different diagnostic groups of headaches (42, 43)) and the quality of life in following brain injury questionnaire (QOILIBRI). Discussion: This pilot study will be the first to evaluate the feasibility of PRP as a potential treatment of GON in patients with post-traumatic headache. Trial Registration: ClinicalTrials.gov - NCT04051203 (registered August 9, 2019), available at https://clinicaltrials.gov/ct2/show/NCT04051203?cond=greater+occipital+neuralgia&draw=2&rank=1