针对老年人慢性下腰痛的针灸“重返行动”实用试验的基线样本特征。
Baseline sample characteristics for the BackInAction pragmatic trial of acupuncture for chronic low back pain in older adults.
作者信息
Justice Morgan, Piccorelli Annie, Avins Andrew L, Cook Andrea J, Eng Carolyn M, Nielsen Arya, Pressman Alice, Stone Katie L, Teets Raymond Y, Wellman Robert, DeBar Lynn L
机构信息
Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.
Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.
出版信息
Contemp Clin Trials. 2025 Aug;155:107981. doi: 10.1016/j.cct.2025.107981. Epub 2025 Jun 6.
BACKGROUND
Chronic low back pain (cLBP) is a leading cause of disability, particularly among older adults. Despite this, effective nonpharmacologic treatments such as acupuncture have not been adequately studied in older adults. The "BackInAction" pragmatic clinical trial aims to address this gap by evaluating the effectiveness of acupuncture in reducing back pain-related disability among adults aged ≥65. The purpose of this manuscript is to compare sample characteristics across sites and across waves of COVID-19.
METHODS
We describe participant baseline characteristics for the BackInAction trial, a three-arm randomized trial conducted across four U.S. healthcare systems: two integrated care delivery, a fee-for-service (FFS) system, and an urban federally qualified health center (FQHC). Participants (N = 800) with cLBP were randomized to receive standard acupuncture, standard acupuncture plus maintenance sessions, or usual medical care. Baseline data were collected through self-reported measures and electronic health records. Recruitment trends are evaluated during COVID waves.
RESULTS
The sample was predominantly female (61.9 %) and non-Hispanic white (64.6 %), with an average age of 73.6 years. The FQHC enrolled a younger, more diverse and socioeconomically disadvantaged population with higher levels of back pain-related dysfunction. The FFS enrolled an older population but had similar rates of back pain-related dysfunction and pain intensity as in the integrated care delivery systems. There were no differences by site corresponding to the circulation of COVID-19 strains.
CONCLUSION
Findings suggest that FQHC populations have higher-than-average social and clinical risks, illustrating the complexity of delivering treatment for cLBP and the urgency to ensure such clinical environments are included in trials.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04982315. Clinical trial registration date: July 29, 2021.
背景
慢性下腰痛（cLBP）是导致残疾的主要原因，在老年人中尤为如此。尽管如此，诸如针灸等有效的非药物治疗方法在老年人中的研究尚不充分。“行动起来对抗背痛”（BackInAction）实用临床试验旨在通过评估针灸对65岁及以上成年人减轻背痛相关残疾的有效性来填补这一空白。本手稿的目的是比较不同地点以及不同新冠疫情阶段的样本特征。
方法
我们描述了“行动起来对抗背痛”试验中参与者的基线特征，这是一项在美国四个医疗系统中开展的三臂随机试验：两个综合医疗服务系统、一个按服务收费（FFS）系统以及一个城市联邦合格健康中心（FQHC）。患有慢性下腰痛的参与者（N = 800）被随机分为三组，分别接受标准针灸治疗、标准针灸加维持治疗或常规医疗护理。基线数据通过自我报告测量和电子健康记录收集。在新冠疫情各阶段评估招募趋势。
结果
样本以女性（61.9%）和非西班牙裔白人（64.6%）为主，平均年龄为73.6岁。FQHC招募的人群更年轻、更多样化且社会经济地位较低，背痛相关功能障碍水平较高。FFS招募的人群年龄较大，但背痛相关功能障碍发生率和疼痛强度与综合医疗服务系统相似。对应新冠病毒毒株传播情况，各地点之间没有差异。
结论
研究结果表明，FQHC人群的社会和临床风险高于平均水平，这说明了为慢性下腰痛提供治疗的复杂性以及确保此类临床环境纳入试验的紧迫性。
试验注册
ClinicalTrials.gov标识符：NCT04982315。临床试验注册日期：2021年7月29日。
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