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Ultrasound-guided platelet-rich plasma injections for post-traumatic greater occipital neuralgia: study protocol for a pilot randomized controlled trial
Pilot and Feasibility Studies Pub Date : 2021-06-22 , DOI: 10.1186/s40814-021-00867-3
Jacqueline E Stone 1 , Tak S Fung 2 , Matthew Machan 1 , Christina Campbell 1 , Rodney Li Pi Shan 1 , Chantel T Debert 1
Affiliation  

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. 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). 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. ClinicalTrials.gov - NCT04051203 (registered August 9, 2019).

中文翻译:

超声引导下注射富血小板血浆治疗创伤后枕大神经痛:一项试验性随机对照试验的研究方案

创伤后头痛 (PTH) 是外伤性脑损伤 (TBI) 的常见后遗症,严重影响患者的功能和生活质量。创伤后枕大神经痛 (GON) 是一种创伤后头痛。常规治疗包括类固醇/麻醉剂注射,通常可以减轻疼痛,但效果持续时间很短。富含血小板的血浆 (PRP) 是一种新兴的生物疗法,可用于治疗多种退行性疾病,包括周围神经疾病。该试点研究的主要目的是评估 PRP 用于治疗创伤后头痛患者的 GON 的随机对照试验在招募、依从性、保留以及依从性和不良事件方面是否可行。探索性目标包括改善疼痛、功能、与类固醇/麻醉剂和生理盐水注射相比,接受 PRP 的创伤后 GON 患者的生活质量和生活质量。三十名患有外伤后 GON 的成人(18 岁以上)将随机分为三组之一:(1)自体 PRP 注射,(2)类固醇/麻醉剂注射(标准护理),或(3)安慰剂注射与正常盐水。将由训练有素的医生在超声引导下对枕大神经进行注射。将在注射前和研究期间收集每日头痛强度和频率数据。可行性将被定义为大于 30% 的招募、70% 的干预完成、70% 的保留和少于 2 次的轻微不良事件。将使用头痛影响测试 6 (HIT-6, 一个有效且可靠的 6 项问卷,用于评估头痛对不同头痛诊断组的影响)和脑损伤后的生活质量问卷 (QOILIBRI)。这项初步研究将首次评估 PRP 作为治疗外伤后头痛患者 GON 的潜在治疗方法的可行性。ClinicalTrials.gov - NCT04051203(2019 年 8 月 9 日注册)。
更新日期:2021-06-22
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