Hybrid Versus In-clinic Rehabilitation for Non-traumatic Shoulder Pain in Routine Care.

NCT07374900 | Completed

• 2 other identifiers: TDN-REHABI-01202600020011-1408-2022-000012
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective longitudinal observational cohort study compared feasibility-allocated hybrid and in-clinic rehabilitation for adults with non-traumatic shoulder pain or dysfunction managed within the same standardized web- and mobile-supported semi-automated shoulder rehabilitation system (WMSSR). The primary outcome was observed time from baseline to documented clinical discharge among completed rehabilitation episodes. Secondary outcomes included total clinical deficit score, maximum pain per visit, number of painful tests per visit, Constant-Murley score at discharge, and adherence to prescribed rehabilitation sessions.

Conditions

Shoulder Pain

Keywords

shoulder pain; physiotherapy; hybrid rehabilitation; home exercise; real-world evidence; shoulder dysfunction; in-clinic rehabilitation; digital rehabilitation; WMSSR; time to clinical discharge

Outcome Measures

Primary Outcomes (1)

• Observed time to documented clinical discharge among completed rehabilitation episodes

  Number of days from the baseline visit (V1) to documented clinical discharge. This outcome was analyzed among rehabilitation episodes with a documented discharge event within the predefined study window. Episodes that discontinued treatment or remained under active follow-up at database closure did not have an observed discharge outcome and were summarized separately.

  From baseline visit (V1) to documented clinical discharge, up to 200 days

Secondary Outcomes (5)

• Change in total clinical deficit score from baseline to discharge

  Baseline visit (V1) and documented clinical discharge, up to 200 days after baseline

• Maximum pain per visit during rehabilitation

  At baseline, at face-to-face reassessments scheduled every 3-5 weeks, and at documented clinical discharge, up to 200 days after baseline

• Number of painful tests per visit during rehabilitation

  At baseline, at face-to-face reassessments scheduled every 3-5 weeks, and at documented clinical discharge, up to 200 days after baseline

• Constant-Murley score at clinical discharge

  At documented clinical discharge, up to 200 days after baseline

• Adherence to prescribed rehabilitation sessions

  Throughout the rehabilitation episode, from baseline until documented clinical discharge, up to 200 days

Study Arms (2)

Group 1: Hybrid rehabilitation

One supervised in-clinic session plus two unsupervised home-based sessions per week. Clinical reassessments were performed face to face every 3-5 weeks, and the exercise prescription was updated according to the participant's clinical evolution.

Group 2: In-clinic rehabilitation

Description: Three supervised in-clinic sessions per week. Clinical reassessments were performed face to face every 3-5 weeks, and the exercise prescription was updated according to the participant's clinical evolution.

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-71 years with non-traumatic shoulder pain or dysfunction persisting for more than 3 months were recruited through social media and institutional email invitations, screened for eligibility, and enrolled in routine outpatient care at TDN Clínica in Noáin, Navarra, Spain. All enrolled participants had access to a smartphone and entered the standardized WMSSR digital rehabilitation workflow. Rehabilitation modality was determined according to the practical feasibility of attending three supervised in-clinic sessions per week. The enrolled cohort comprised 159 participants contributing 164 initiated rehabilitation episodes.

You may qualify if:

• Non-traumatic shoulder pain or dysfunction persisting for more than 3 months before study entry
• Access to a smartphone to view the prescribed exercise instructions

You may not qualify if:

• Acute fractures or dislocations
• Arthritis/osteoarthritis
• Osteosarcoma or osteomyelitis
• Recent shoulder surgery

Sponsors & Collaborators

• Universidad Pública de Navarra: lead

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.

  PMID: 28173784 RESULT

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological 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
• 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: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)