Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jun 23, 2025
Date Accepted: May 4, 2026
Digital Rehabilitation Following Ultrasound-Guided Injection for Chronic Rotator Cuff Injury: A Randomized Controlled Trial
ABSTRACT
Background:
Chronic rotator cuff injuries (CRCI) often lead to shoulder pain and dysfunction. Although ultrasound-guided injections provide rapid pain relief, subsequent rehabilitation efficacy is often compromised by poor exercise adherence and inaccurate movement execution. Digital therapeutics may enhance patient engagement and movement accuracy, potentially improving outcomes.
Objective:
This study compared the effects of ultrasound-guided corticosteroid + local anesthetic injection combined with the Digital Rehabilitation System training versus traditional exercise on pain intensity, shoulder function, and movement accuracy in CRCI patients.
Methods:
A single-center, single-blind, superiority randomized controlled trial was conducted. Sixty eligible participants were randomized to either the Conventional Treatment Group (Group C, n=30) or the Digital Treatment Group (Group D, n=30) for a 3-month intervention. Following pain-alleviating ultrasound-guided injections, the Group C performed prescribed exercises, while the Group D used the intelligent system for self-corrective adaptive training. Primary outcome was the Constant-Murley Score (CMS). Secondary outcomes included the University of California Los Angeles Shoulder Scale (UCLA), Numerical Rating Scale (NRS) for pain, range of motion (ROM), and movement accuracy scores. Assessments occurred at baseline (T1), 1-week (T2), 1-month (T3), and 3-month (T4) follow-ups.
Results:
No significant between-group differences existed in baseline characteristics or outcome measures (all P>.05). No group × time interactions were observed for any outcomes. At T4, the Group D demonstrated significantly greater improvements in CMS (P=.007; Hodges-Lehmann estimator [HLE]=-6; 95% CI: -10 to -2), UCLA (P=.001; HLE=-2; 95% CI: -4 to -1), and NRS (P=.002; HLE=1; 95% CI: 0 to 2), and their improvement values (Δ) all exceeded the corresponding minimal clinically important differences. ROM also showed significant intergroup differences in all planes. Compared with T1, ROM was significantly improved in both groups at T4, with the greatest improvement in abduction (Δ Group C=20.7, Δ Group D=30.5). Between-group differences in improvement were significant for CMS (P=.016), UCLA (P<.001), NRS (P<.001), and forward flexion (P=.032) but not for abduction, external rotation, or internal rotation. Subgroup analysis revealed better enhanced shoulder function and ROM in participants with pre-existing shoulder motion restrictions using digital therapy.
Conclusions:
For participants with CRCI, combining ultrasound-guided injection with subsequent Digital Rehabilitation System training achieves greater shoulder ROM and functional scores compared to traditional exercise after pain relief. This approach demonstrates enhanced efficacy in subgroups with shoulder mobility limitations. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2500097903; https://www.chictr.org.cn/showproj.html?proj=257213
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