NCT07374900

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 15, 2026

Last Update Submit

January 23, 2026

Conditions

Keywords

shoulder painphysiotherapyhybrid rehabilitationhome exercisetime to dischargereal-world evidence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in total clinical deficit score

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

  • Change in pain (VAS / composite VAS)

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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TDN Clínica Traumatología y Rehabilitación SLP

Noaín, Navarre, 31110, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • José A Sanz, PHD

    Universidad Pública de Navarra

    STUDY DIRECTOR
  • Igor Setuain, PHD

    TDN Clinica

    STUDY DIRECTOR
  • Iban Latasa, PHD

    IED Electronics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
200 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 29, 2026

Study Start

March 17, 2025

Primary Completion

November 11, 2025

Study Completion

November 11, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations