AAOS 2024 best paper in the shoulder and elbow classification: watchful waiting provides higher value with similar functional outcomes to physical therapy for frozen shoulder: a prospective randomized controlled trial.

Background: Physical therapy remains a ubiquitous treatment modality for the management of frozen shoulder (adhesive capsulitis) despite limited high-level evidence supporting its use. Leveraging patient-reported outcome measures (PROMs) and healthcare costs, this study compared patient outcomes and value achieved through watchful waiting (WW) vs. physical therapy (PT) for conservative management of frozen shoulder.

Methods: Patients in this prospective, parallel randomized controlled trial who were diagnosed with frozen shoulder were randomized 1:1 to WW or PT. All patients were offered therapeutic, intra-articular corticosteroid injections (CSIs). The primary outcome was the American Shoulder and Elbow Surgeons Score. Secondary outcomes included patient value (ie, 12-month American Shoulder and Elbow Surgeons score divided by healthcare costs), the Disabilities of the Arm, Shoulder, and Hand questionnaire, and Visual Analog Scale pain. Due to the confidentiality of internal hospital data, all economic outcomes were divided by an undisclosed constant to set the normalized study mean for direct costs to 1000; similarly, patient value was normalized to set the study mean to 100. Outcomes were assessed at baseline, 6 weeks, 3 months, 6 months, and 12 months using mixed-effects models, with sensitivity analyses adjusting for nonlinear improvement trajectories and CSIs.

Results: Between November 2014 and November 2022, 175 patients were screened, 61 of whom (34.9%) were randomized to WW (31 patients) or PT (30 patients). Forty-seven patients (96%) received at least one CSI, with no significant difference in CSI administration between cohorts (P = .29). Relative to baseline scores, patients from both cohorts improved significantly at each time point for all PROMs (P < .05 for all), with no significant differences in PROMs between groups at any time point (P > .05 for all). However, compared to those assigned WW, patients randomized to PT incurred 10.0× higher costs (normalized mean difference: 1636; 95% CI: 967, 2304; P < .001) and achieved only 16.9% of the patient value (normalized mean difference: -147.0; 95% CI: -207.5, -86.5; P < .001). These results held across all sensitivity analyses.

Conclusion: Relative to WW, patients randomized to PT reported similar PROMs but incurred significantly higher direct costs (10.0×) and imposed a greater economic burden on the healthcare system (3.4-6.0×). Accordingly, WW resulted in significantly higher (5.9×) patient value than PT. Although additional high-level, multicenter studies are needed to corroborate these findings, the present study may support physicians and patients in pursuing the most appropriate treatment plan for each patient based on their individualized needs and preferences.