Long Cynthia R, Salsbury Stacie A, Vining Robert D, Lisi Anthony J, Corber Lance, Twist Elissa, Abrams Thad, Wallace Robert B, Goertz Christine M
Palmer Center for Chiropractic Research, Davenport, Palmer College of Chiropractic, 741 Brady St, Davenport, IA, 52803, USA.
Yale Center for Medical Informatics, Yale University, New Haven, CT, USA.
Pilot Feasibility Stud. 2022 Mar 7;8(1):54. doi: 10.1186/s40814-022-01008-0.
Over 25% of veterans seeking care at U.S. Veterans Health Administration facilities have chronic low back pain (LBP), with high rates of mental health comorbidities. The primary objective of this study was to assess the feasibility of participant recruitment, retention, and electronic data collection to prepare for the subsequent randomized trial of multimodal chiropractic care for pain management of veterans with chronic low back pain. The secondary objectives were to estimate effect sizes and variability of the primary outcome and choose secondary outcomes for the full-scale trial.
This single-arm pilot trial enrolled 40 veterans with chronic LBP at one Veterans Health Administration facility for a 10-week course of pragmatic multimodal chiropractic care. Recruitment was by (1) provider referral, (2) invitational letter from the electronic health record pre-screening, and (3) standard direct recruitment. We administered patient-reported outcome assessments through an email link to REDCap, an electronic data capture platform, at baseline and 5 additional timepoints. Retention was tracked through adherence to the treatment plan and completion rates of outcome assessments. Descriptive statistics were calculated for baseline characteristics and outcome variables.
We screened 91 veterans over 6 months to enroll our goal of 40 participants. Seventy percent were recruited through provider referrals. Mean age (range) was 53 (22-79) years and 23% were female; 95% had mental health comorbidities. The mean number of chiropractic visits was 4.5 (1-7). Participants adhered to their treatment plan, with exception of 3 who attended only their first visit. All participants completed assessments at the in-person baseline visit and 80% at the week 10 final endpoint. We had no issues administering assessments via REDCap. We observed clinically important improvements on the Roland-Morris Disability Questionnaire [mean change (SD): 3.6 (6.1)] and on PROMIS® pain interference [mean change (SD): 3.6 (5.6)], which will be our primary and key secondary outcome, respectively, for the full-scale trial.
We demonstrated the feasibility of participant recruitment, retention, and electronic data collection for conducting a pragmatic clinical trial of chiropractic care in a Veterans Health Administration facility. Using the pilot data and lessons learned, we modified and refined a protocol for a full-scale, multisite, pragmatic, National Institutes of Health-funded randomized trial of multimodal chiropractic care for veterans with chronic LBP that began recruitment in February 2021.
ClinicalTrials.gov NCT03254719.
在美国退伍军人健康管理局设施中寻求治疗的退伍军人中，超过25%患有慢性腰痛（LBP），且心理健康合并症发生率很高。本研究的主要目的是评估参与者招募、留存以及电子数据收集的可行性，为随后针对患有慢性腰痛的退伍军人进行多模式脊椎按摩治疗疼痛管理的随机试验做准备。次要目的是估计主要结局的效应大小和变异性，并为全面试验选择次要结局。
这项单臂试点试验在一家退伍军人健康管理局设施中招募了40名患有慢性腰痛的退伍军人，进行为期10周的实用多模式脊椎按摩治疗课程。招募方式为：（1）提供者转诊；（2）通过电子健康记录预筛查发出邀请信；（3）标准直接招募。我们通过电子邮件链接向电子数据捕获平台REDCap进行患者报告结局评估，评估时间点为基线以及另外5个时间点。通过对治疗计划的依从性和结局评估完成率来跟踪留存情况。计算基线特征和结局变量的描述性统计数据。
在6个月内我们筛选了91名退伍军人，以招募到40名参与者的目标。70%是通过提供者转诊招募的。平均年龄（范围）为53（22 - 79）岁，23%为女性；95%有心理健康合并症。脊椎按摩治疗的平均就诊次数为4.5（1 - 7）次。除了3人只参加了首次就诊外，参与者都遵守了他们的治疗计划。所有参与者在基线面对面就诊时完成了评估，在第10周最终终点时80%的参与者完成了评估。我们通过REDCap进行评估没有问题。我们观察到罗兰 - 莫里斯残疾问卷[平均变化（标准差）：3.6（6.1）]和PROMIS®疼痛干扰[平均变化（标准差）：3.6（5.6）]有临床上重要的改善，在全面试验中，这将分别是我们的主要结局和关键次要结局。
我们证明了在退伍军人健康管理局设施中进行脊椎按摩治疗实用临床试验时，参与者招募、留存和电子数据收集的可行性。利用试点数据和经验教训，我们修改并完善了一项方案，用于开展一项由美国国立卫生研究院资助的针对患有慢性腰痛退伍军人的多模式脊椎按摩治疗的全面、多地点、实用随机试验，该试验于2021年2月开始招募。
ClinicalTrials.gov NCT03254719。
