Shoulder PainNCT07374900
Hybrid Versus In-clinic Rehabilitation for Non-traumatic Shoulder Pain in Routine Care.
An observational study of Shoulder Pain, run by Universidad Pública de Navarra at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Shoulder Pain
- How many people
- 159 participants
- Where
- 1 siteSpain
- Study dates
- 17 Mar 2025to 11 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Acute fractures or dislocations
- Arthritis/osteoarthritis
- Osteosarcoma or osteomyelitis
- Recent shoulder surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site
TDN Clínica Traumatología y Rehabilitación SLP
Noaín, Navarre, 31110
About this study
Official title: 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.
Read the 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:
- 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.
- 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
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline visit (V1) and documented clinical discharge, up to 200 days after baseline
Maximum pain per visit during rehabilitation
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.
Measured: 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
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.
Measured: 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
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.
Measured: At documented clinical discharge, up to 200 days after baseline
Adherence to prescribed rehabilitation sessions
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.
Measured: Throughout the rehabilitation episode, from baseline until documented clinical discharge, up to 200 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start17 Mar 2025
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José A Sanz, PHD, Study director, Universidad Pública de NavarraIgor Setuain, PHD, Study director, TDN ClinicaIban Latasa, PHD, Study director, IED Electronics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374900
- Sponsor's protocol ID
- TDN-REHABI-0120260002
- Other IDs
- 0011-1408-2022-000012
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 28173784
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Versus In-clinic Rehabilitation for Non-traumatic Shoulder Pain Within a Standardized Digital Care Pathway: a Prospective Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT07374900
- Acronym / sponsor ID
- TDN-REHABI-0120260002
- Conditions
- Shoulder Pain
- Keywords
- shoulder pain, physiotherapy, hybrid rehabilitation, home exercise, real-world evidence, shoulder dysfunction, in-clinic rehabilitation, digital rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Acute fractures or dislocations
- Arthritis/osteoarthritis
- Osteosarcoma or osteomyelitis
- Recent shoulder surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
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
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
Constant-Murley score at clinical discharge
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 28173784Setuain 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José A Sanz, PHD study director
Universidad Pública de Navarra
Igor Setuain, PHD study director
TDN Clinica
Iban Latasa, PHD study director
IED Electronics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by Universidad Pública de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed time to documented clinical discharge among completed rehabilitation episodes (time frame: From baseline visit (V1) to documented clinical discharge, up to 200 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07374900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.