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

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.

Study Overview

• Status: Completed
• Conditions: Digital Shoulder Rehabilitation

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.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• Spain
  • Navarre
    • Noaín, Navarre, Spain, 31110
      • TDN Clínica Traumatología y Rehabilitación SLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with musculoskeletal shoulder pain treated in a private sports physiotherapy clinic in Pamplona, Spain, who are referred or self-referred for conservative management, consecutively enrolled in the REHABI digital rehabilitation program, and who have access to and basic skills to use a smartphone.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1: Hybrid rehabilitation; 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:three supervised in-person sessions per week, delivered in 3-week cycles according to the REHABI protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to clinical discharge	Days from first visit (baseline, V1) to clinical discharge.	From baseline (V1) until discharge (end of rehabilitation episode, approximately 1 to 6 months after baseline, depending on clinical evolution)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total clinical deficit score	Total deficit score (points) at baseline and discharge; change = baseline - discharge.	baseline and discharge (approximately 1 to 6 months after baseline, depending on clinical evolution)
Change in pain (VAS / composite VAS)	VAS (0-10) and/or composite VAS at baseline and discharge; change.	baseline and discharge (approximately 1 to 6 months after baseline, depending on clinical evolution)

Collaborators and Investigators

• Sponsor: Universidad Pública de Navarra
• Investigators: Study Director: Igor Setuain, PHD, TDN Clinica; Study Director: José A Sanz, PHD, Universidad Pública de Navarra; Study Director: Iban Latasa, PHD, IED Electronics

Publications and helpful links

General Publications

• Setuain I, Gonzalez-Izal M, Paularena A, Luque JL, Andersen LL, Izquierdo M. A protocol for a new methodological model for work-related shoulder complex injuries: From diagnosis to rehabilitation. BMC Musculoskelet Disord. 2017 Feb 7;18(1):70. doi: 10.1186/s12891-017-1435-2.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Actual): November 11, 2025
• Study Completion (Actual): November 11, 2025

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: physiotherapy; home exercise; shoulder pain; real-world evidence; hybrid rehabilitation; time to discharge
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Pain
• Other Study ID Numbers: TDN-REHABI-0120260002; 0011-1408-2022-000012 (Other Identifier: Beca de Doctorado Industrial 2022 del Gobierno de Navarra)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At present, there is no plan to share individual participant data (IPD). This is a single-center study with a relatively small sample and detailed clinical assessments, which may increase the risk of re-identification, and the original informed consent did not explicitly cover broad IPD sharing. De-identified summary results will be available in the published manuscript, and additional aggregated information may be considered upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No