Ultrasound Guided Platelet rich Plasma Injections for Post-Traumatic Greater Occipital Neuralgia: A Randomized Controlled trial Protocol

Abstract

\n Background: Traumatic brain injury (TBI) is a leading cause of death and disability worldwide. 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 study is to evaluate the pain response of a single perineural PRP injection in the treatment of post-traumatic GON.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. The primary outcome will be the change in headache intensity, as measured by a reduction on the numerical pain rating scale (NPRS) at 3 months post-injection in the PRP group, versus the normal saline and steroid groups. Secondary outcomes will include adverse effects, prn medication usage, and impact on function and quality of life as measured by the Headache Impact Test 6 (HIT-6) and Quality of Life following Brain Injury (QOILIBRI) questionnaires. Discussion: This trial will evaluate the efficacy of PRP injections as a treatment for post-traumatic GON. This research will further our understanding of PTH, GON, and the treatment of peripheral neuralgias.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