Abstract
BackgroundPost-traumatic headaches (PTH) are a common sequelae of traumatic brain injury (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 include improvement in pain, function, and quality of life in patients with post-traumatic GON receiving PRP compared to steroid/anesthetic and normal saline injections.MethodsThirty 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 Headache Impact Test-6 (HIT-6, a valid and reliable 6-item questionnaire for assessment of the impact of headaches across different diagnostic groups of headaches) and the quality of life in following brain injury questionnaire (QOILIBRI).DiscussionThis 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 registrationClinicalTrials.gov - NCT04051203 (registered August 9, 2019).
Highlights
Post-traumatic headaches (PTH) are a common sequelae of traumatic brain injury (TBI) and greatly impact patient function and quality of life
This study will investigate the feasibility of a randomized control pilot study for the treatment of greater occipital neuralgia (GON) in patients with post-traumatic headache using Platelet-rich plasma (PRP)
Our specific objectives are the following: 1. Evaluate the feasibility of a randomized pilot study of PRP as a treatment for patients with GON and post-traumatic headache in terms of recruitment, attendance (70% intervention appointment attendance), retention
Summary
Study design Prospective, randomized, controlled, double-blinded pilot trial evaluating the feasibility in relation to recruitment, retention, and acceptability of a single perineural PRP injection compared to that of steroid/anesthetic injection or injection with normal saline to the greater occipital nerve as a treatment for GON in patients following TBI. Once a participant is referred and has provided consent to contact, they will be contacted by a member of our research team If they meet inclusion criteria at that time, an initial assessment will be scheduled and participants will complete a digital informed consent. Participants will be randomized (via sealed envelope) by a blinded research assistant in a 1:1 fashion to one of three treatment arms: (1) autologous PRP injection, (2) steroid/anesthetic injection (standard care), or (3) placebo injection with normal saline. Two 3 mL syringes with 2 mL of injectate (PRP, steroid/anesthetic, or normal saline) will be prepared for each participant. Headache is reported to have developed within 7 days after one of the following: 1. The injury to the head
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