Comparing Digital to Conventional Physical Therapy for Chronic Shoulder Pain: Randomized Controlled Trial

Abstract

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.

Keywords: chronic shoulder; clinical outcome; digital care; digital health intervention; musculoskeletal pain; pain management; physical therapy; remote sensing technology; telerehabilitation.

Figure 1

Schematic representation of the intervention for each group: the digital group (left side) and the control group (right side). CBT: cognitive behavioral therapy.

Figure 2

CONSORT (Consolidated Standards of Reporting Trials) flow diagram illustrating the participant flow throughout the study.

Figure 3

Longitudinal changes across time for (A) short-form of Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH) and (B) average pain until intervention-end per group. The colored lines depict the mean trajectories for each group, with shadowing representing CIs. Individual trajectories are depicted in light gray lines.