Bailey Jeannie F, Agarwal Vibhu, Zheng Patricia, Smuck Matthew, Fredericson Michael, Kennedy David J, Krauss Jeffrey
Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, United States.
Hinge Health, Inc, San Francisco, CA, United States.
J Med Internet Res. 2020 May 11;22(5):e18250. doi: 10.2196/18250.
Chronic musculoskeletal pain has a vast global prevalence and economic burden. Conservative therapies are universally recommended but require patient engagement and self-management to be effective.
This study aimed to evaluate the efficacy of a 12-week digital care program (DCP) in a large population of patients with chronic knee and back pain.
A longitudinal observational study was conducted using a remote DCP available through a mobile app. Subjects participated in a 12-week multimodal DCP incorporating education, sensor-guided exercise therapy (ET), and behavioral health support with 1-on-1 remote health coaching. The primary outcome was pain measured by the visual analog scale (VAS). Secondary measures included engagement levels, program completion, program satisfaction, condition-specific pain measures, depression, anxiety, and work productivity.
A total of 10,264 adults with either knee (n=3796) or low back (n=6468) pain for at least three months were included in the study. Participants experienced a 68.45% average improvement in VAS pain between baseline intake and 12 weeks. In all, 73.04% (7497/10,264) participants completed the DCP into the final month. In total, 78.60% (5893/7497) of program completers (7144/10,264, 69.60% of all participants) achieved minimally important change in pain. Furthermore, the number of ET sessions and coaching interactions were both positively associated with improvement in pain, suggesting that the amount of engagement influenced outcomes. Secondary outcomes included a 57.9% and 58.3% decrease in depression and anxiety scores, respectively, and 61.5% improvement in work productivity. Finally, 3 distinct clusters of pain response trajectories were identified, which could be predicted with a mean 76% accuracy using baseline measures.
These results support the efficacy and scalability of a DCP for chronic low back and knee pain in a large, diverse, real-world population. Participants demonstrated high completion and engagement rates and a significant positive relationship between engagement and pain reduction was identified, a finding that has not been previously demonstrated in a DCP. Furthermore, the large sample size allowed for the identification of distinct pain response subgroups, which may prove beneficial in predicting recovery and tailoring future interventions. This is the first longitudinal digital health study to analyze pain outcomes in a sample of this magnitude, and it supports the prospect for DCPs to serve the overwhelming number of musculoskeletal pain sufferers worldwide.
慢性肌肉骨骼疼痛在全球范围内普遍存在，且经济负担沉重。保守疗法是普遍推荐的，但需要患者积极参与和自我管理才能有效。
本研究旨在评估一项为期12周的数字护理计划（DCP）对大量慢性膝痛和背痛患者的疗效。
采用一项纵向观察性研究，使用通过移动应用程序提供的远程DCP。受试者参加了一项为期12周的多模式DCP，该计划包括教育、传感器引导的运动疗法（ET）以及一对一远程健康指导下的行为健康支持。主要结局指标是用视觉模拟量表（VAS）测量的疼痛。次要指标包括参与程度、计划完成情况、计划满意度、特定病情的疼痛指标、抑郁、焦虑和工作效率。
共有10264名患有膝痛（n = 3796）或腰痛（n = 6468）至少三个月的成年人纳入研究。参与者在基线入组时和12周之间VAS疼痛平均改善了68.45%。总体而言，73.04%（7497/10264）的参与者完成了DCP至最后一个月。总共有78.60%（5893/7497）的计划完成者（7144/10264，占所有参与者的69.60%）在疼痛方面实现了最小重要变化。此外，ET课程次数和指导互动次数均与疼痛改善呈正相关，表明参与程度影响了结局。次要结局包括抑郁和焦虑评分分别下降57.9%和58.3%，以及工作效率提高61.5%。最后，确定了3种不同的疼痛反应轨迹聚类，使用基线测量可以平均76%的准确率进行预测。
这些结果支持了DCP对大量、多样化的真实世界人群中慢性腰痛和膝痛的疗效和可扩展性。参与者表现出高完成率和参与率，并且确定了参与和疼痛减轻之间存在显著的正相关关系，这一发现此前在DCP中尚未得到证实。此外，大样本量使得能够识别不同的疼痛反应亚组，这可能有助于预测恢复情况并为未来干预措施提供个性化方案。这是第一项纵向数字健康研究，在如此大规模的样本中分析疼痛结局，并且支持了DCP为全球大量肌肉骨骼疼痛患者服务的前景。
