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

August 4, 2026 updated by: Universidad Pública de Navarra

Hybrid Versus In-clinic Rehabilitation for Non-traumatic Shoulder Pain Within a Standardized Digital Care Pathway: a Prospective Longitudinal Observational Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 within the same standardized web- and mobile-supported semi-automated shoulder rehabilitation system (WMSSR) between March and September 2025 and followed within the study until 11 November 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 in-clinic rehabilitation (3 supervised in-clinic sessions/week).

WMSSR 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 performance was recorded using a 0-10 visual analogue scale (VAS). Pain-related variables included maximum pain per visit, the number of test records with VAS >0 within the 24-test assessment, and a composite VAS used to summarize episode-level pain burden and support discharge assessment. 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 describe and compare observed time from baseline to documented clinical discharge among completed rehabilitation episodes managed with hybrid versus in-clinic rehabilitation.

(2) To describe and compare discharge total clinical deficit score and Constant-Murley score between rehabilitation modalities.

(3) To describe longitudinal changes in maximum pain and the number of painful tests across assessment visits in both rehabilitation modalities.

(4) To describe adherence to prescribed rehabilitation sessions in each rehabilitation modality.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria Age 18-71 years

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Observed time to documented clinical discharge among completed rehabilitation episodes
Time Frame: From baseline visit (V1) to documented clinical discharge, up to 200 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in total clinical deficit score from baseline to discharge
Time Frame: Baseline visit (V1) and documented clinical discharge, up to 200 days after baseline
The total clinical deficit score was calculated from the standardized 24-test shoulder assessment and ranged from 0 to 36 points, with higher scores indicating greater clinical impairment. Change was calculated as baseline score minus discharge score; therefore, positive values indicate a reduction in clinical deficit. The analysis included rehabilitation episodes with paired baseline and documented discharge assessments.
Baseline visit (V1) and documented clinical discharge, up to 200 days after baseline
Maximum pain per visit during rehabilitation
Time Frame: At baseline, at face-to-face reassessments scheduled every 3-5 weeks, and at documented clinical discharge, up to 200 days after baseline
Pain during test performance was recorded using a 0-10 visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the greatest pain intensity. Maximum pain per visit was defined as the highest VAS value recorded across the test records completed at a given assessment visit. Values were summarized at baseline, across scheduled reassessments, and at documented clinical discharge. Lower values indicate less pain.
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
Time Frame: At baseline, at face-to-face reassessments scheduled every 3-5 weeks, and at documented clinical discharge, up to 200 days after baseline
The number of painful tests per visit was defined as the count of test records with VAS >0 within the standardized 24-test shoulder assessment. One episode-level count was calculated for each assessment visit. Values were summarized at baseline, across scheduled reassessments, and at documented clinical discharge. Lower counts indicate fewer painful responses during the assessment.
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
Time Frame: At documented clinical discharge, up to 200 days after baseline
The Constant-Murley score was recorded at documented clinical discharge as an additional measure of shoulder functional status. The score ranges from 0 to 100 points, with higher values indicating better shoulder function. It was measured at discharge only and was not included among the predefined clinical discharge criteria.
At documented clinical discharge, up to 200 days after baseline
Adherence to prescribed rehabilitation sessions
Time Frame: Throughout the rehabilitation episode, from baseline until documented clinical discharge, up to 200 days
Episode-level rehabilitation adherence was calculated as the percentage of prescribed rehabilitation sessions completed during the rehabilitation episode: (number of completed prescribed sessions / total number of prescribed sessions) × 100. In the hybrid group, prescribed sessions included one supervised in-clinic session and two unsupervised home-based sessions per week. In the in-clinic group, prescribed sessions included three supervised in-clinic sessions per week. Higher percentages indicate greater adherence.
Throughout the rehabilitation episode, from baseline until documented clinical discharge, up to 200 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Pública de Navarra

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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