Functional and Neurotrophic Outcomes After Physical Therapy and Injection-Based Treatments for Rotator Cuff Tendinopathy: The FORTIS Pilot Randomized Trial.

BACKGROUND: Rotator cuff tendinopathy (RCT) causes chronic shoulder pain, functional limitation, and sleep disturbance. Although physical therapy (PT) and injection-based interventions are widely used, their comparative clinical effects and neurotrophic mechanisms remain insufficiently defined. PURPOSE: To compare clinical and neurotrophic outcomes of PT alone versus PT combined with injection-based interventions in patients with chronic RCT. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: A total of 29 patients (29 shoulders) with MRI-confirmed supraspinatus tendinopathy and sleep disturbance (Pittsburgh Sleep Quality Index score ≥5) were randomized to 1 of 4 groups: PT (n = 7), PT with subacromial steroid injection (PT + SSI; n = 6), PT with suprascapular nerve block (PT + SSNB; n = 8), or PT with platelet-rich plasma injection (PT + PRP; n = 8). All participants completed a standardized 12-week PT program. Clinical outcomes were assessed at baseline (time zero [T0]), 1 month (T1), and 3 months (T3). Serum brain-derived neurotrophic factor (BDNF) was measured at T0 and T1. Wilcoxon and Kruskal-Wallis tests assessed within- and between-group differences. RESULTS: All groups demonstrated clinical improvement, most consistently in pain, insomnia severity, shoulder function, and cognitive performance. PT + PRP improved across pain, insomnia, and shoulder function outcomes (P≤ .03). PT showed significant improvements in pain, insomnia severity, shoulder function, and processing speed (all P≤ .04). PT + SSI demonstrated early pain reduction at 1 month (P = .03), whereas PT + SSNB showed selective improvements in sleep quality (P = .02) and executive function (P = .04). No significant between-group differences were observed in serum BDNF levels. Only PT demonstrated significant correlations between BDNF changes and reductions in pain and insomnia severity (P < .01). CONCLUSION: Our study demonstrated that PT alone was associated with coordinated short-term clinical improvement and neurotrophic correlates, supporting its role as a core component of nonoperative management of RCT. Injection-based adjuncts produced selective, time-limited effects. These findings suggest that structured PT should remain the cornerstone of nonoperative management, while injections may serve as adjuncts to facilitate short-term symptom relief and rehabilitation engagement rather than as stand-alone treatments. REGISTRATION: NCT06631976 (ClinicalTrials.gov identifier).