Department of Physical Therapy and Rehabilitation, University of California San Francisco, San Francisco, CA, United States.
Sword Health Inc, Draper, UT, United States.
J Med Internet Res. 2023 Aug 18;25:e49236. doi: 10.2196/49236.
BACKGROUND: Chronic shoulder pain (CSP) is a common condition with various etiologies, including rotator cuff disorders, adhesive capsulitis, shoulder instability, and shoulder arthritis. It is associated with substantial disability and psychological distress, resulting in poor productivity and quality of life. Physical therapy constitutes the mainstay treatment for CSP, but several barriers exist in accessing care. In recent years, telerehabilitation has gained momentum as a potential solution to overcome such barriers. It has shown numerous benefits, including improving access and convenience, promoting patient adherence, and reducing costs. However, to date, no previous randomized controlled trial has compared fully remote digital physical therapy to in-person rehabilitation for nonoperative CSP. OBJECTIVE: The aim of this study is to compare clinical outcomes between digital physical therapy and conventional in-person physical therapy in patients with CSP. METHODS: We conducted a single-center, parallel-group, randomized controlled trial involving 82 patients with CSP referred for outpatient physical therapy. Participants were randomized into digital or conventional physical therapy (8-week interventions). The digital intervention consisted of home exercise, education, and cognitive behavioral therapy (CBT), using a device with movement digitalization for biofeedback and asynchronous physical therapist monitoring through a cloud-based portal. The conventional group received in-person physical therapy, including exercises, manual therapy, education, and CBT. The primary outcome was the change (baseline to 8 weeks) in function and symptoms using the short-form of Disabilities of the Arm, Shoulder, and Hand questionnaire. Secondary outcome measures included self-reported pain, surgery intent, analgesic intake, mental health, engagement, and satisfaction. All questionnaires were delivered electronically. RESULTS: A total of 90 participants were randomized into digital or conventional physical therapy, with 82 receiving the allocated intervention. Both groups experienced significant improvements in function measured by the short-form of the Disabilities of the Arm, Shoulder, and Hand questionnaire, with no differences between groups (-1.8, 95% CI -13.5 to 9.8; P=.75). For secondary outcomes, no differences were observed in surgery intent, analgesic intake, and mental health or worst pain. Higher reductions were observed in average and least pain in the conventional group, which, given the small effect sizes (least pain 0.15 and average pain 0.16), are unlikely to be clinically meaningful. High adherence and satisfaction were observed in both groups, with no adverse events. CONCLUSIONS: This study shows that fully remote digital programs can be viable care delivery models for CSP given their scalability and effectiveness, assessed through comparison with high-dosage in-person rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04636528); https://clinicaltrials.gov/study/NCT04636528.
背景:慢性肩部疼痛(CSP)是一种常见病症,其病因多种多样,包括肩袖疾病、粘连性囊炎、肩关节不稳定和肩关节关节炎。它与严重的残疾和心理困扰有关,导致生产力下降和生活质量降低。物理治疗是 CSP 的主要治疗方法,但在获得治疗方面存在一些障碍。近年来,远程康复作为克服这些障碍的一种潜在解决方案而得到了发展。它具有许多益处,包括提高可及性和便利性、促进患者依从性和降低成本。然而,迄今为止,尚无先前的随机对照试验比较过非手术性 CSP 的全远程数字物理治疗与面对面康复治疗的临床效果。
目的:本研究旨在比较数字物理治疗与 CSP 患者常规门诊物理治疗的临床效果。
方法:我们进行了一项单中心、平行组、随机对照试验,共纳入 82 名因肩部疼痛而接受门诊物理治疗的患者。参与者被随机分为数字或常规物理治疗组(8 周干预)。数字干预包括家庭运动、教育和认知行为疗法(CBT),使用具有运动数字化功能的设备进行生物反馈,并通过基于云的门户进行异步物理治疗师监测。常规组接受面对面的物理治疗,包括运动、手动治疗、教育和 CBT。主要结局是采用简式上肢功能障碍问卷(DASH)评估功能和症状的变化(基线至 8 周)。次要结局包括自我报告的疼痛、手术意向、镇痛药摄入、心理健康、参与度和满意度。所有问卷均通过电子方式提供。
结果:共有 90 名参与者被随机分配至数字或常规物理治疗组,其中 82 名接受了分配的干预措施。两组的功能均有显著改善,DASH 问卷评分降低,两组间无差异(-1.8,95%置信区间-13.5 至 9.8;P=0.75)。对于次要结局,手术意向、镇痛药摄入和心理健康或最差疼痛方面无差异。常规组的平均疼痛和最小疼痛降低幅度较大,考虑到较小的效应量(最小疼痛 0.15,平均疼痛 0.16),这可能没有临床意义。两组的依从性和满意度均较高,无不良事件发生。
结论:本研究表明,完全远程数字方案可以作为 CSP 的可行护理模式,因为它们具有可扩展性和有效性,通过与高剂量的面对面康复治疗进行比较可以评估。
试验注册:ClinicalTrials.gov(NCT04636528);https://clinicaltrials.gov/study/NCT04636528。
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