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基于计步器的互联网介导干预对慢性下腰痛成人的影响:随机对照试验

Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial.

作者信息

Krein Sarah L, Kadri Reema, Hughes Maria, Kerr Eve A, Piette John D, Holleman Rob, Kim Hyungjin Myra, Richardson Caroline R

机构信息

VA Ann Arbor Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI 48113, USA.

出版信息

J Med Internet Res. 2013 Aug 19;15(8):e181. doi: 10.2196/jmir.2605.

Abstract

BACKGROUND

Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program.

OBJECTIVE

The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability.

METHODS

A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points.

RESULTS

Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant.

CONCLUSIONS

Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements.

TRIAL REGISTRATION

ClinicalTrials.gov NCT00694018; http://clinicaltrials.gov/ct2/show/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E).

摘要

背景

慢性疼痛,尤其是背痛,是一种普遍存在的疾病,与残疾、健康状况不佳、焦虑和抑郁、生活质量下降以及医疗服务使用和费用增加有关。目前的证据表明,运动是管理慢性疼痛的有效策略。然而,很少有临床项目使用普遍可用的工具和相对低成本的方法来帮助慢性背痛患者启动并维持运动计划。

目的

本研究的目的是确定基于计步器的互联网介导干预是否可以减少与慢性背痛相关的残疾。

方法

进行了一项平行组随机对照试验,按1:1分配至干预组或常规护理组。从一个退伍军人事务部(VA)医疗系统招募了229名非特异性慢性背痛退伍军人。随机分配至干预组的参与者收到一个可上传数据的计步器,并可访问一个网站,该网站通过电子社区提供自动步行目标、反馈、激励信息和社会支持(n = 111)。常规护理参与者(n = 118)也收到可上传数据的计步器,但未收到自动反馈,也无法访问该网站。主要结局在6个月(次要)和12个月(主要)时使用罗兰·莫里斯残疾问卷(RDQ)进行测量,平均得分差异至少为2被认为具有临床意义。使用线性混合效应模型进行了完整病例分析和所有病例分析,以评估两个研究组在两个时间点的差异。

结果

两组的基线平均RDQ得分均大于9。在6个月和12个月时,干预组和常规护理组约90%的参与者提供了主要结局数据。在6个月时,干预组参与者的平均RDQ得分为7.2,而常规护理组为9.2,完整病例分析的调整差异为1.6(95%CI 0.3 - 2.8,P = 0.02),所有病例分析的调整差异为1.2(95%CI -0.09至2.5,P = 0.07)。对基线RDQ得分≥4的患者进行的事后分析显示,两组在6个月时的调整差异更大,但在12个月时差异不再具有统计学意义。

结论

与接受常规护理的参与者相比,干预组参与者在研究入组后的6个月内报告与背痛相关的残疾有更大程度的降低。组间差异在报告基线残疾水平较高的患者中尤为突出,但在12个月后未持续存在。主要地,自动化干预可能是帮助患者管理慢性背痛的有效方法;可能需要额外的支持以确保持续改善。

试验注册

ClinicalTrials.gov NCT00694018;http://clinicaltrials.gov/ct2/show/NCT00694018(由WebCite存档于http://www.webcitation.org/6IsG4Y90E)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b35/3758050/8ee0467f50ea/jmir_v15i8e181_fig1.jpg

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