Johns Hopkins School of Nursing, 525 N. Wolfe Street, Room 421, Baltimore, MD, 21205, USA.
Departments of Psychiatry, Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Trials. 2020 Jan 20;21(1):99. doi: 10.1186/s13063-019-4016-x.
BACKGROUND: Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those aged 60 years or older in the US. Despite the development of pharmacological and nonpharmacological interventions, cLBP outcomes have not improved and disability rates continue to rise. This study aims to test auricular point acupressure (APA) as a non-invasive, nonpharmacological self-management strategy to manage cLBP and to address current shortcomings of cLBP treatment. METHODS/DESIGN: For this prospective randomized controlled study, participants will be randomly assigned to three groups: (1) APA group (active points related to cLBP), (2) Comparison group-1 (non-active points, unrelated to cLBP), and (3) Comparison group-2 (enhanced educational control, an educational booklet on cLBP will be given and the treatment used by participants for their cLBP will be recorded). The ecological momentary assessment smartphone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. This proposed trial will evaluate the APA sustained effects for cLBP at 12-month follow-up. Monthly telephone follow-up will be used to collect study outcomes. Blood will be collected during study visits at baseline, post APA treatment, and follow-up study visits at 1, 3, 6, 9 and 12 months post completion of treatment for a total of seven assessments. Appointments will start between 9 and 11 am to control for circadian variation in cytokine levels. DISCUSSION: This study is expected to provide vital information on the efficacy, sustainability, and underlying mechanism of APA on cLBP necessary for APA to gain acceptance from both healthcare providers and patients, which would provide a strong impetus for including APA as part of cLBP management in clinical and home settings. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03589703. Registered on 22 May 2018.
背景:慢性下腰痛(cLBP)是一个主要的健康问题,也是美国 60 岁及以上人群中最常见的疼痛病症。尽管已经开发了药理学和非药理学干预措施,但 cLBP 的治疗效果并没有改善,残疾率仍在继续上升。本研究旨在测试耳穴按压(APA)作为一种非侵入性、非药物的自我管理策略,以治疗 cLBP,并解决当前 cLBP 治疗的不足。
方法/设计:对于这项前瞻性随机对照研究,参与者将被随机分配到三组:(1)APA 组(与 cLBP 相关的活性点),(2)对照组 1(非活性点,与 cLBP 无关),和(3)对照组 2(增强教育控制,将提供一本关于 cLBP 的教育手册,并记录参与者用于治疗 cLBP 的治疗方法)。使用生态瞬时评估智能手机应用程序实时收集 cLBP 结果和 APA 实践的依从性。所有参与者将通过问卷测量治疗和非特异性心理安慰剂效应。这项拟议的试验将在 12 个月的随访中评估 APA 对 cLBP 的持续效果。每月通过电话随访收集研究结果。在基线、APA 治疗后和治疗完成后 1、3、6、9 和 12 个月的随访研究访问中采集血液,共进行七次评估。预约将在上午 9 点至 11 点之间开始,以控制细胞因子水平的昼夜变化。
讨论:这项研究预计将提供关于 APA 对 cLBP 的疗效、可持续性和潜在机制的重要信息,这对于 APA 获得医疗保健提供者和患者的认可至关重要,这将为将 APA 纳入临床和家庭环境中 cLBP 管理提供强有力的动力。
试验注册:ClinicalTrials.gov,编号:NCT03589703。注册于 2018 年 5 月 22 日。
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