Rotator Cuff InjuriesPROTONCT05913050
Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment
A study testing Therapeutic resistance exercise and Education in people with Rotator Cuff Injuries, run by Hospital Universitario Fundación Alcorcón at 1 site in Spain.
Trial summary
The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Therapeutic resistance exercise and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 18 Sep 2026
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Full-thickness supraspinatus rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging.
- Pain during resisted abduction and/or external rotation.
- Pain intensity equal or greater to 3 points on a numeric pain rating scale, or a degree of disability equal or greater to 15% on the Shoulder Pain and Disability Index.
- Pain lasting for at least 3 months.
- Adequate comprehension of written and spoken Spanish
Who cannot join
- Loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side.
- Suspected neck-related shoulder pain.
- Suspected visceral-related shoulder pain.
- Sings or symptoms of shoulder instability, including dislocations and/or subluxation within the last year.
- Humerus and/or scapular fractures within the last year.
- Previous rotator cuff repair surgery within the last year.
- Presence of cancer, fibromyalgia, neurological and/or other systemic diseases.
- Cognitive impairment that makes it impossible to perform therapeutic exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment (the PROTO Study): a Multivariable Prediction Model Development Study
The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.
Read the detailed description
A multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors:
- Body mass index [kg/m2, Fractional polynomials FP2].
- Smoking [Years, linear relationship].
- Employment status [3 categories].
- Maximum education degree [4 categories].
- Previous performance of physical exercise [2 categories].
- Baseline disability (measured with the Shoulder Pain and Disability Index) [Fractional polynomials FP2].
- Baseline pain intensity (measured with a numeric pain rating scale) [Fractional polynomials FP2].
- Pain duration [Weeks, linear relationship]
- Pain catastrophizing (measured with the Pain Catastrophizing Scale) [Linear relationship].
- Patient's expectations (measured with the Musculoskeletal Outcomes Data Evaluation and Management System) [Linear relationship].
- Conditions
- Rotator Cuff Injuries
- Being tested
- Therapeutic resistance exercise, Education
- Keywords
- Physical therapy, Rotator cuff, Full-thickness tear, Exercise, Education, Prediction model
- Medical subject headings
- Rotator Cuff Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic resistance exerciseOther
Therapeutic exercise program based on individualized progressive resistance exercises performed during 3 months at home, with a frequency of 1-3 sessions per week at the hospital.
EducationOther
Education applied during all the therapeutic process, focusing on diverting the patient's attention away from the structural lesion, explaining the relationship between pain/disability and tissue injury, explaining the meaning of pain during exercises, and explaining the objectives of the implemented treatments.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise plus education | Experimental | The treatment will consist of a progressive resistance exercise program along with education. Receives: Other: Therapeutic resistance exercise; Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder disability
Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability).
Measured: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Secondary outcomes (2)
Shoulder pain intensity
Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).
Measured: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Need for surgery
Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).
Measured: 3-month, 6-month, and 1-year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 May 2024
- Primary completion18 Sep 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Why it stopped: Financial support for the project has been discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will be a non-controlled multicenter clinical trial with the main aim of developing a multivariable prediction model of the improvements after a physical therapy treatment based on exercise and education.
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Fundación Alcorcón
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Fuenlabrada, Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital General Universitario Gregorio Marañon, Hospital Universitario Principe de Asturias
- Responsible party
- Principal investigator, Rubén Fernández Matías, Hospital Universitario Fundación Alcorcón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913050
- Sponsor's protocol ID
- 23/66
- Acronym
- PROTO
- Status last verified
- May 2025
- First submitted
- 9 Jun 2023
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will be shared with other researcher upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment (the PROTO Study): a Multivariable Prediction Model Development Study
- ClinicalTrials.gov ID
- NCT05913050
- Acronym / sponsor ID
- PROTO / 23/66
- Conditions
- Rotator Cuff Injuries
- Keywords
- Physical therapy, Rotator cuff, Full-thickness tear, Exercise, Education, Prediction model
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Financial support for the project has been discontinued.
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Hospital Universitario Fundación AlcorcónUniversity, hospital or other
- Collaborators
- Hospital Universitario de Fuenlabrada, Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital General Universitario Gregorio Marañon, Hospital Universitario Principe de Asturias
- Study start
- 1 May 2024 (actual)
- Primary completion
- 18 Sep 2026 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 22 Jun 2023 (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.
The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.
Detailed description
A multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors:
- Body mass index [kg/m2, Fractional polynomials FP2].
- Smoking [Years, linear relationship].
- Employment status [3 categories].
- Maximum education degree [4 categories].
- Previous performance of physical exercise [2 categories].
- Baseline disability (measured with the Shoulder Pain and Disability Index) [Fractional polynomials FP2].
- Baseline pain intensity (measured with a numeric pain rating scale) [Fractional polynomials FP2].
- Pain duration [Weeks, linear relationship]
- Pain catastrophizing (measured with the Pain Catastrophizing Scale) [Linear relationship].
- Patient's expectations (measured with the Musculoskeletal Outcomes Data Evaluation and Management System) [Linear relationship].
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be a non-controlled multicenter clinical trial with the main aim of developing a multivariable prediction model of the improvements after a physical therapy treatment based on exercise and education.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise plus education | Experimental | Other: Therapeutic resistance exercise, Other: EducationThe treatment will consist of a progressive resistance exercise program along with education. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Full-thickness supraspinatus rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging.
- Pain during resisted abduction and/or external rotation.
- Pain intensity equal or greater to 3 points on a numeric pain rating scale, or a degree of disability equal or greater to 15% on the Shoulder Pain and Disability Index.
- Pain lasting for at least 3 months.
- Adequate comprehension of written and spoken Spanish
Key exclusion criteria (8 listed)
- Loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side.
- Suspected neck-related shoulder pain.
- Suspected visceral-related shoulder pain.
- Sings or symptoms of shoulder instability, including dislocations and/or subluxation within the last year.
- Humerus and/or scapular fractures within the last year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic resistance exerciseTherapeutic exercise program based on individualized progressive resistance exercises performed during 3 months at home, with a frequency of 1-3 sessions per week at the hospital. | Other | Therapeutic exercise plus education |
| EducationEducation applied during all the therapeutic process, focusing on diverting the patient's attention away from the structural lesion, explaining the relationship between pain/disability and tissue injury, explaining the meaning of pain during exercises, and explaining the objectives of the implemented treatments. | Other | Therapeutic exercise plus education |
Primary outcome
Shoulder disability
Time frame: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability).
2 secondary outcomes
Shoulder pain intensity
Time frame: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Need for surgery
Time frame: 3-month, 6-month, and 1-year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No. IPD data will be shared with other researcher 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic resistance exercise and Education in people with Rotator Cuff Injuries, run by Hospital Universitario Fundación Alcorcón 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 5 inclusion and 8 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: paused, as of the sponsor's last update on 25 May 2025. 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?
Results are not available in the source record.
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?
Shoulder disability (time frame: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.