Protocol for a multicenter, randomised controlled trial of surgeon-directed home therapy vs. outpatient rehabilitation by physical therapists for reverse total shoulder arthroplasty: the SHORT trial

Abstract

Background Reverse total shoulder arthroplasty (RTSA) has emerged as a successful surgery with expanding indications. Outcomes may be influenced by post-operative rehabilitation; however, there is a dearth of research regarding optimal rehabilitation strategy following RTSA. The primary purpose of this study is to compare patient reported and clinical outcomes after RTSA in two groups: in one group rehabilitation is directed by formal, outpatient clinic-based physical therapists (PT group) as compared to a home therapy group, in which patients are instructed in their rehabilitative exercises by surgeons at post-operative appointments (HT group). Secondary aims include comparisons of complications, cost of care and quality of life between the two groups. Methods This randomised controlled trial has commenced at seven sites across the United States. Data is being collected on 200 subjects by clinical research assistants pre-operatively and post-operatively at 2, 6, and 12 weeks, 6 months, 1 and 2 year visits. The following variables are being assessed: American Shoulder and Elbow Surgeons (ASES), pain level using the numeric pain scale, the Single Assessment Numeric Evaluation (SANE) score, and shoulder active and passive range of motion for analysis of the primary aim. Chi square and t-tests will be used to measure differences in baseline characteristics of both groups. Repeated measures linear mixed effects modeling for measurement of differences will be used for outcomes associated with ASES and SANE and scores, and range of motion measures. Secondary aims will be analyzed for comparison of complications, cost, and quality of life assessment scores using data obtained from the PROMIS 29 v. 2, questionnaires administered at standard of care post-operative visits, and the electronic health record. Subjects will be allowed to crossover between the PT and HT groups, and analysis will include both intention-to-treat including patients who crossed over, and a second with cross-over patients removed, truncated to the time they crossed over. Discussion RTSA is being performed with increasing frequency, and the optimal rehabilitation strategy is unclear. This study will help clarify the role of formal physical therapy with particular consideration to outcomes, cost, and complications. In addition, this study will evaluate a proposed rehabilitation strategy. Trial registration This study is registered as NCT03719859 at ClincialTrials.gov.

Factors influencing physical therapy utilization after shoulder surgery: a retrospective review

“…Given that PT utilization, length, and exercises vary for different shoulder surgeries, this may have played a role in PT utilization as well as costs. 20 , 26 , 29 , 43 However, the overall use of therapy postoperatively is consistent. Additionally, given the retrospective nature of the study, there may be an element of selection bias present for the patients included in the study.…”

Direct active rehabilitation after reverse total shoulder arthroplasty: an international multicentre prospective cohort safety study with 1-year follow up

“…Complications and re-admissions were recorded at all follow up moments. Complications were classified as potentially related to the rehabilitation strategy (eg, acromial/scapular spine stress fractures, shoulder dislocation)15 or as other intraoperative and postoperative complications related to surgery (eg, infection, nerve problems, haematoma). Furthermore, the following PROMs were completed by the patients: (1) the validated Dutch version of the Oxford Shoulder Score (OSS), a 12-item questionnaire regarding pain and function of the shoulder (scores range from 0 to 48), with higher scores indicating better shoulder function and less pain;16 17 (2) EuroQol-5 Dimensions-3 Levels (EQ-5D-3L), a health-related quality of life measure with a self-rating of health status (range 0–100, 100 is the best imaginable health status)18 and (3) Numeric Pain Rating Scale (NPRS) in rest and in motion (range 0–10, 10 means the worst possible pain) 19.…”

Outcomes of reverse total shoulder arthroplasty were not adversely affected by the COVID-19 pandemic

“… 17 Current trials are working to elucidate the exact role of physical therapy for RTSA patients relating to outcome, costs and complications. 9 …”