超声引导下富血小板血浆注射治疗创伤后枕大神经痛：一项初步随机对照试验的研究方案
Ultrasound-guided platelet-rich plasma injections for post-traumatic greater occipital neuralgia: study protocol for a pilot randomized controlled trial.
作者信息
Stone Jacqueline E, Fung Tak S, Machan Matthew, Campbell Christina, Shan Rodney Li Pi, Debert Chantel T
机构信息
Department of Clinical Neurosciences, Division of Physical Medicine and Rehabilitation, University of Calgary, 1403 29 Street NW, Calgary, Alberta, T2N 2T9, Canada.
Information Technologies, University of Calgary, Calgary, Alberta, Canada.
出版信息
Pilot Feasibility Stud. 2021 Jun 22;7(1):130. doi: 10.1186/s40814-021-00867-3.
BACKGROUND
Post-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.
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 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).
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).
背景
创伤后头痛（PTH）是创伤性脑损伤（TBI）的常见后遗症，对患者的功能和生活质量有很大影响。创伤后枕大神经痛（GON）是创伤后头痛的一种类型。传统治疗方法包括类固醇/麻醉剂注射，通常可缓解疼痛，但效果持续时间较短。富血小板血浆（PRP）是一种新兴的生物治疗方法，可用于治疗多种退行性疾病，包括周围神经疾病。这项初步研究的主要目的是评估在招募、依从性、保留率以及依从性和不良事件方面，对创伤后头痛患者进行PRP治疗GON的随机对照试验是否可行。探索性目标包括比较接受PRP治疗的创伤后GON患者与接受类固醇/麻醉剂和生理盐水注射的患者在疼痛、功能和生活质量方面的改善情况。
方法
30名成年（18岁以上）创伤后GON患者将被随机分为三组之一：（1）自体PRP注射，（2）类固醇/麻醉剂注射（标准治疗），或（3）生理盐水安慰剂注射。由经过培训的医生在超声引导下对枕大神经进行注射。在注射前以及研究期间收集每日头痛强度和频率数据。可行性将定义为招募率大于30%、干预完成率70%、保留率70%以及轻微不良事件少于2起。将使用头痛影响测试-6（HIT-6，一份有效且可靠的6项问卷，用于评估头痛对不同诊断组头痛的影响）和脑损伤后生活质量问卷（QOILIBRI）来探索探索性结果。
讨论
这项初步研究将首次评估PRP作为创伤后头痛患者GON潜在治疗方法的可行性。
试验注册
ClinicalTrials.gov - NCT04051203（2019年8月9日注册）。
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