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Completed

NCT Number: NCT07374900

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

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.

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Key information

Conditions

Digital Shoulder Rehabilitation Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Observational

Primary location

TDN Clínica Traumatología y Rehabilitación SLP

Noaín, Navarre, 31110, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to clinical discharge

    Time frame: From baseline (V1) until discharge (end of rehabilitation episode, approximately 1 to 6 months after baseline, depending on clinical evolution)

    Days from first visit (baseline, V1) to clinical discharge.

Secondary outcomes

  1. Change in total clinical deficit score

    Time frame: baseline and discharge (approximately 1 to 6 months after baseline, depending on clinical evolution)

    Total deficit score (points) at baseline and discharge; change = baseline - discharge.

  2. Change in pain (VAS / composite VAS)

    Time frame: baseline and discharge (approximately 1 to 6 months after baseline, depending on clinical evolution)

    VAS (0-10) and/or composite VAS at baseline and discharge; change.

Sponsors and collaborators

Lead sponsor

Universidad Pública de Navarra

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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