OBJECTIVES: To integrate patient-reported outcome measures (PROMs) and health care costs to compare the value achieved by watchful waiting (WW) versus physical therapy (PT) for the conservative management of adhesive capsulitis (frozen shoulder).

METHODS: Patients in this prospective, parallel randomized controlled trial who were diagnosed with adhesive capsulitis of the shoulder were randomized 1:1 to WW or PT. The primary outcome was the American Shoulder and Elbow Surgeons Score (ASES), and secondary outcomes included patient value (defined here as the 12-month ASES score divided by health care costs), the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and Visual Analog Scale (VAS) pain scores. Outcomes were assessed at baseline and at 6 weeks, 3 months, 6 months, and 12 months. Primary analyses were conducted following intention-to-treat principles using linear mixed-effects models. Sensitivity analyses incorporated nonlinear mixed-effects models and as-treated analyses.

RESULTS: Between November 2014 and November 2022, we screened 175 patients, 61 of whom (34.9%) were assigned WW (31 patients, 51.8%) or PT (30 patients, 49.2%). Relative to baseline scores, patients from both cohorts improved significantly at each time point and for all PROMs (p < 0.05 for all). However, there were no significant differences in PROMs between treatment modalities at any time point (p > 0.05 for all). Compared to those assigned WW, patients randomized to PT incurred 9.98x higher costs (normalized mean difference: 1,635.67, 95% confidence interval: 967.19 to 2,304.15; p < 0.001) and achieved only 16.9% of the patient value (normalized mean difference: -146.97, 95% confidence interval: -207.47 to -86.47; p < 0.001). These results held across a range of sensitivity analyses.

CONCLUSIONS: In this study, patients randomized to PT reported similar PROMs but significantly higher costs than those undergoing WW, demonstrating WW as the higher value treatment modality for the conservative management of adhesive capsulitis.