NCT07374900

Hybrid Versus Fully In-person Physiotherapy for Non-traumatic Shoulder Pain in Routine Care.

Hybrid Versus Fully In-person Physiotherapy for Non-traumatic Shoulder Pain in Routine Care: a Prospective Consecutive Observational Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: Universidad Pública de Navarra · Academic / Other
• Sex: All
• Age: 18 Years – 71 Years
• Healthy volunteers: Not accepted

Summary

Prospective consecutive observational cohort study in routine care comparing hybrid versus fully in-person supervised physiotherapy for non-traumatic shoulder pain/dysfunction delivered under the standardized REHABI program. The primary outcome is time to clinical discharge (days from first visit to discharge). Secondary outcomes include change in pain (VAS/composite VAS) and change in total clinical deficit score from baseline to discharge.

Detailed description

This prospective consecutive observational study was conducted in routine outpatient care at TDN Clínica (Navarra, Spain) to assess whether outcomes differ between two physiotherapy delivery formats for adults with non-traumatic shoulder pain/dysfunction managed under the same standardized digital workflow (REHABI) between March and September 2025. Allocation to format was feasibility-based (non-random) according to routine-care constraints (e.g., work schedule, transport, distance). Both formats were delivered at a nominal frequency of three sessions/week: hybrid (1 supervised in-person session plus 2 unsupervised home sessions supported by smartphone access to prescribed exercises) and fully in-person (3 supervised in-person sessions/week). REHABI integrates a structured assessment-prescription-reassessment process. Patients completed a standardized 24-test functional battery at baseline (visit 1) and at follow-up evaluations scheduled every 3-5 weeks until clinical discharge. The battery includes measures of strength (digital dynamometry), range of motion (manual goniometry), flexibility, and clinical tests. Pain intensity during test execution was recorded using a 0-10 visual analogue scale (VAS/EVA) in 16 of the 24 tests; a composite VAS was also used to support discharge decisions. Test scoring yields a total clinical deficit score. Clinical discharge was defined within the workflow using explicit criteria (deficit score threshold, symmetric strength, functional ROM, and low pain during tests). Study objectives: (1) To assess whether time to clinical discharge (days from baseline to discharge) differs between patients managed with hybrid versus fully in-person rehabilitation in routine care. (2) To assess whether changes from baseline to discharge in pain (VAS/EVA and composite VAS, as recorded) and in the total clinical deficit score differ between formats.

Conditions

• Digital Shoulder Rehabilitation

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-11-11
• Completion: 2025-11-11
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: Spain