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

U

Universidad Pública de Navarra

Status

Completed

Conditions

Digital Shoulder Rehabilitation

Study type

Observational

Funder types

Other

Identifiers

NCT07374900
TDN-REHABI-0120260002
0011-1408-2022-000012 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

All

Ages

18 to 71 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Age 18-71 years
  • Non-traumatic shoulder pain/dysfunction
  • Access to a smartphone to view exercises
  • Completion of a full rehabilitation episode within the study period

Exclusion Criteria:

  • Acute fractures or dislocations
  • Arthritis/osteoarthritis
  • Osteosarcoma or osteomyelitis
  • Recent shoulder surgery
  • Incomplete rehabilitation episode or missing baseline/discharge data

Trial design

129 participants in 2 patient groups

Group 1: Hybrid rehabilitation
Description:
One supervised in-person session plus two remote (non-face-to-face) sessions per week, delivered in 3-week cycles.
Group 2: In-person rehabilitation
Description:
Description:three supervised in-person sessions per week, delivered in 3-week cycles according to the REHABI protocol.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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