Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.
Department of Physical Medicine and Rehabilitation, St Olavs Hospital, Trondheim, Norway.
JAMA Netw Open. 2023 Jun 1;6(6):e2320400. doi: 10.1001/jamanetworkopen.2023.20400.
Self-management is a key element in the care of persistent neck and low back pain. Individually tailored self-management support delivered via a smartphone app in a specialist care setting has not been tested.
To determine the effect of individually tailored self-management support delivered via an artificial intelligence-based app (SELFBACK) adjunct to usual care vs usual care alone or nontailored web-based self-management support (e-Help) on musculoskeletal health.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial recruited adults 18 years or older with neck and/or low back pain who had been referred to and accepted on a waiting list for specialist care at a multidisciplinary hospital outpatient clinic for back, neck, and shoulder rehabilitation. Participants were enrolled from July 9, 2020, to April 29, 2021. Of 377 patients assessed for eligibility, 76 did not complete the baseline questionnaire, and 7 did not meet the eligibility criteria (ie, did not own a smartphone, were unable to take part in exercise, or had language barriers); the remaining 294 patients were included in the study and randomized to 3 parallel groups, with follow-up of 6 months.
Participants were randomly assigned to receive app-based individually tailored self-management support in addition to usual care (app group), web-based nontailored self-management support in addition to usual care (e-Help group), or usual care alone (usual care group).
The primary outcome was change in musculoskeletal health measured by the Musculoskeletal Health Questionnaire (MSK-HQ) at 3 months. Secondary outcomes included change in musculoskeletal health measured by the MSK-HQ at 6 weeks and 6 months and pain-related disability, pain intensity, pain-related cognition, and health-related quality of life at 6 weeks, 3 months, and 6 months.
Among 294 participants (mean [SD] age, 50.6 [14.9] years; 173 women [58.8%]), 99 were randomized to the app group, 98 to the e-Help group, and 97 to the usual care group. At 3 months, 243 participants (82.7%) had complete data on the primary outcome. In the intention-to-treat analysis at 3 months, the adjusted mean difference in MSK-HQ score between the app and usual care groups was 0.62 points (95% CI, -1.66 to 2.90 points; P = .60). The adjusted mean difference between the app and e-Help groups was 1.08 points (95% CI, -1.24 to 3.41 points; P = .36).
In this randomized clinical trial, individually tailored self-management support delivered via an artificial intelligence-based app adjunct to usual care was not significantly more effective in improving musculoskeletal health than usual care alone or web-based nontailored self-management support in patients with neck and/or low back pain referred to specialist care. Further research is needed to investigate the utility of implementing digitally supported self-management interventions in the specialist care setting and to identify instruments that capture changes in self-management behavior.
ClinicalTrials.gov Identifier: NCT04463043.
自我管理是持续性颈部和下背部疼痛护理的关键要素。在专家护理环境中，通过智能手机应用程序提供个性化定制的自我管理支持，尚未经过测试。
确定通过人工智能为基础的应用程序（SELFBACK）附加常规护理与常规护理或非个性化基于网络的自我管理支持（e-Help）对肌肉骨骼健康的影响。
设计、地点和参与者：这项随机临床试验招募了年龄在 18 岁及以上的颈部和/或下背部疼痛患者，他们已经被转诊到多学科医院门诊诊所接受背部、颈部和肩部康复治疗，并接受了专家护理的等候名单。参与者于 2020 年 7 月 9 日至 2021 年 4 月 29 日期间进行了评估。在 377 名符合条件的患者中，有 76 名未完成基线问卷，7 名不符合资格标准（即没有智能手机、无法参加运动或存在语言障碍）；其余 294 名患者被纳入研究并随机分为 3 个平行组，随访 6 个月。
参与者被随机分配接受基于应用程序的个性化自我管理支持，外加常规护理（应用程序组）、基于网络的非个性化自我管理支持，外加常规护理（e-Help 组）或常规护理（常规护理组）。
主要结果是在 3 个月时通过肌肉骨骼健康问卷（MSK-HQ）测量的肌肉骨骼健康变化。次要结果包括在 6 周和 6 个月时通过 MSK-HQ 测量的肌肉骨骼健康变化，以及在 6 周、3 个月和 6 个月时的疼痛相关残疾、疼痛强度、疼痛相关认知和健康相关生活质量。
在 294 名参与者（平均[标准差]年龄 50.6[14.9]岁；173 名女性[58.8%]）中，99 名被随机分配到应用程序组，98 名到 e-Help 组，97 名到常规护理组。在 3 个月时，243 名参与者（82.7%）有主要结局的完整数据。在 3 个月时的意向治疗分析中，应用程序组和常规护理组的 MSK-HQ 评分调整后的平均差异为 0.62 分（95%CI，-1.66 至 2.90 分；P=0.60）。应用程序组和 e-Help 组之间的调整后平均差异为 1.08 分（95%CI，-1.24 至 3.41 分；P=0.36）。
在这项随机临床试验中，通过人工智能为基础的应用程序附加常规护理提供的个性化自我管理支持，在改善颈部和/或下背部疼痛患者的肌肉骨骼健康方面，与常规护理或基于网络的非个性化自我管理支持相比，并没有显著更有效。需要进一步研究以调查在专家护理环境中实施数字支持的自我管理干预的效用，并确定用于捕获自我管理行为变化的工具。
ClinicalTrials.gov 标识符：NCT04463043。
