作者
Sang S. Pak,Dora Janela,Nina Freitas,Fabíola Costa,Robert Moulder,Maria Molinos,A. C. Areias,Virgílio Bento,Steven Paul Cohen,Vijay Yanamadala,Richard Souza,Fernando Dias Correia
摘要
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 (PT) constitutes the mainstay treatment for CSP, but several barriers exist in accessing care. In recent years, telerehabilitation 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 prior RCT has compared fully-remote digital physical therapy (DGPT) to in-person rehabilitation for non-operative CSP. OBJECTIVE The aim of this study is to compare clinical outcomes between DGPT and conventional in-person physical therapy in patients with CSP. METHODS Single-center, parallel-group, randomized controlled trial (RCT) 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. 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 (QuickDASH). Secondary outcome measures included self-reported pain, surgery intent, analgesics intake, mental health, engagement, and satisfaction. All questionnaires were delivered electronically. RESULTS Ninety participants were randomized into digital or conventional physical therapy, with 82 receiving the allocated intervention. Both groups experienced significant improvements in function (QuickDASH), 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; 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 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. CLINICALTRIAL ClinicalTrials.gov (NCT04636528)