Rotator Cuff Related Shoulder PainNCT07885878
Implementation of Shoulder School in Albania
A study testing Shoulder school in people with Rotator Cuff Related Shoulder Pain, run by University of Valladolid.
Trial summary
Shoulder pain is a common musculoskeletal condition that can cause pain, movement limitations, disability, and difficulties performing daily and occupational activities. Rotator cuff-related shoulder pain (RCRSP) is one of the most common clinical presentations among people seeking care for shoulder problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Related Shoulder Pain
- What is being tested?
- Shoulder school
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1)aged over 18 years; 2) shoulder pain lasting more than six weeks; 3) shoulder pain attributable to rotator cuff tendinopathy or tendinosis, bursitis or impingement, according to the diagnostic criteria of the most recent clinical guidelines, international consensus
- and the British Shoulder and Elbow Society; and 4) ability to understand and complete the evaluation questionnaires.
Who cannot join
- 1) presence of red-flag symptoms suggesting fractures, dislocations, or complete tendon tears, among others; 2) neurological disorders; 3) other severe shoulder pathologies such as inflammatory arthritis, frozen shoulder, or glenohumeral instability; 4) corticosteroid injections or physical therapy treatment within the last six months; 5) prior shoulder surgery; 6) pregnancy; 7) or cognitive deficits that could limit comprehension of questionnaires or participation in testing.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of Shoulder School in Albania. A Multicenter Prospective Randomized Clinical Trial
Shoulder pain is a common musculoskeletal condition that can cause pain, movement limitations, disability, and difficulties performing daily and occupational activities. Rotator cuff-related shoulder pain (RCRSP) is one of the most common clinical presentations among people seeking care for shoulder problems.
Exercise therapy is recommended as a first-line conservative treatment for RCRSP. Progressive resistance training and motor control exercises can improve pain and shoulder function, while exercises targeting thoracic mobility and scapular and glenohumeral function may be useful for addressing individual movement and functional limitations. However, there is still uncertainty about the optimal selection, intensity, volume, and progression of exercises for individual patients.
Read more
Objective To analyze the effects of a shoulder school program led by a physiotherapist and based on therapeutic exercise focused on active scapular and thoracic work, compared to conventional treatment in patients with RCRSP referred to Primary Care Physiotherapy Units in Albania, regarding pain, functional capacity, and quality of life.
Methods Design: Single-blind, multicenter, prospective, randomized, controlled non-inferiority study.
Sample: Patients with RCRSP referred to primary care in Albania. Dependent Variables: Pain, functional capacity, quality of life, joint mobility, isometrical strenght, and patient satisfaction.
Independent Variables:
Intervention group: Shoulder school program including exercises focused on scapular, thoracic, and rotator cuff function.
Control group: Conventional physiotherapy treatment.
Randomization: Cluster randomization by centers. Analysis: Data will be analyzed using SPSS version 25.0.
Clinical Implications This study will provide objective data on the effects of implementing a group exercise program guided by a physiotherapist. The results could offer evidence for a resource that may be highly useful in Primary Care Physiotherapy. This approach has the potential to optimize labor, time, and space resources within this healthcare service.
- Conditions
- Rotator Cuff Related Shoulder Pain
- Being tested
- Shoulder school, Standard Care (in control arm)
- Keywords
- rotator cuff-related shoulder pain, exercise, pain, disability, quality of life
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder schoolOther
A therapeutic exercise protocol will be carried out, consisting of 2 sessions per week for 8 weeks, supervised and guided by a physiotherapist. The objective is to improve thoracic mobility, as well as the strength and motor control of the scapular retractor and protractor muscles (middle and lower trapezius, rhomboids, and serratus anterior) and the rotator cuff.
Standard Care (in control arm)Other
The protocol will include the application of therapeutic ultrasound, TENS, and kinesitherapy which will be applied through classic shoulder mobility exercises.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder school | Experimental | A therapeutic exercise protocol will be carried out, consisting of 2 sessions per week for 8 weeks, supervised and guided by a physiotherapist. The objective is to improve thoracic mobility, as well as the strength and motor control of the scapular retractor and protractor muscles (middle and lower trapezius, rhomboids, and serratus anterior) and the rotator cuff. Receives: Other: Shoulder school |
| Standard protocol | Active comparator | The protocol will include the application of therapeutic ultrasound, TENS, and kinesitherapy which will be applied through classic shoulder mobility exercises. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured with visual analogue scale
Visual analogue scale is a subjective pain intensity measurement tool in which subjects are asked to indicate their perceived pain intensity on a 10 cm line. Patients will be informed that the left end of the scale represents "no pain" and the right end represents "the worst pain imaginable." It will be explained that marking closer to the right corresponds to a higher score (10 cm) and greater pain, while marking closer to the left corresponds to a lower score (0 cm) and a better state of health.
Measured: From enrollment through treatment completion and up to 3 months of follow-up
Secondary outcomes (4)
Disability measured with Disabilities of the Arm, Shoulder and Hand Questionnaire
The DASH questionnaire (Disabilities of the Arm, Shoulder and Hand) is a 30-item self-report tool used to measure upper extremity disability and symptoms. It evaluates a patient's ability to perform everyday activities using a 1-to-5 Likert scale for each question.
The final score ranges from 0 to 100, where 0 represents no disability and 100 indicates severe disability.
Measured: From enrollment through treatment completion and up to 3 months of follow-up
Quality of life measured with EuroQol 5-Dimensions 5-Levels
The EQ-5D-5L stands for EuroQol 5-Dimensions 5-Levels, a standardized questionnaire used to measure health-related quality of life.
It evaluates five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension is rated across five severity levels, ranging from "no problems" to "extreme problems." The tool also features a Visual Analogue Scale (EQ-VAS) for patients to rate their overall health from 0 to 100.
Measured: From enrollment through treatment completion and up to 3 months of follow-up
Range of motion measured with inclinometer
The range of motion of the shoulder will be carried out using a digital inclinometer for the movements of flexion, abduction, internal and external rotation of the arm.
Measured: From enrollment through treatment completion and up to 3 months of follow-up
Isometric strenght measured with isometric dynamometer (Lafayette 01655)
Isometric strength will be assessed using the isometric dynamometer model Lafayette 01655 for the movements of elevation of the arm, and internal and external rotation of the glenohumeral joint
Measured: From enrollment through treatment completion and up to 3 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Related 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- European University of Tirana
- Responsible party
- Principal investigator, Sandra Jiménez-del-Barrio, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885878
- Sponsor's protocol ID
- UVa (ID3145/2)
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Shoulder School in Albania. A Multicenter Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07885878
- Acronym / sponsor ID
- UVa (ID3145/2)
- Conditions
- Rotator Cuff Related Shoulder Pain
- Keywords
- rotator cuff-related shoulder pain, exercise, pain, disability, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- European University of Tirana
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 21 Oct 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.
Shoulder pain is a common musculoskeletal condition that can cause pain, movement limitations, disability, and difficulties performing daily and occupational activities. Rotator cuff-related shoulder pain (RCRSP) is one of the most common clinical presentations among people seeking care for shoulder problems.
Exercise therapy is recommended as a first-line conservative treatment for RCRSP. Progressive resistance training and motor control exercises can improve pain and shoulder function, while exercises targeting thoracic mobility and scapular and glenohumeral function may be useful for addressing individual movement and functional limitations. However, there is still uncertainty about the optimal selection, intensity, volume, and progression of exercises for individual patients.
Objective To analyze the effects of a shoulder school program led by a physiotherapist and based on therapeutic exercise focused on active scapular and thoracic work, compared to conventional treatment in patients with RCRSP referred to Primary Care Physiotherapy Units in Albania, regarding pain, functional capacity, and quality of life.
Methods Design: Single-blind, multicenter, prospective, randomized, controlled non-inferiority study.
Sample: Patients with RCRSP referred to primary care in Albania. Dependent Variables: Pain, functional capacity, quality of life, joint mobility, isometrical strenght, and patient satisfaction.
Independent Variables:
Intervention group: Shoulder school program including exercises focused on scapular, thoracic, and rotator cuff function.
Control group: Conventional physiotherapy treatment.
Randomization: Cluster randomization by centers. Analysis: Data will be analyzed using SPSS version 25.0.
Clinical Implications This study will provide objective data on the effects of implementing a group exercise program guided by a physiotherapist. The results could offer evidence for a resource that may be highly useful in Primary Care Physiotherapy. This approach has the potential to optimize labor, time, and space resources within this healthcare service.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder school | Experimental | Other: Shoulder schoolA therapeutic exercise protocol will be carried out, consisting of 2 sessions per week for 8 weeks, supervised and guided by a physiotherapist. The objective is to improve thoracic mobility, as well as the strength and motor control of the scapular retractor and protractor muscles (middle and lower trapezius, rhomboids, and serratus anterior) and the rotator cuff. |
| Standard protocol | Active comparator | Other: Standard Care (in control arm)The protocol will include the application of therapeutic ultrasound, TENS, and kinesitherapy which will be applied through classic shoulder mobility exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1)aged over 18 years; 2) shoulder pain lasting more than six weeks; 3) shoulder pain attributable to rotator cuff tendinopathy or tendinosis, bursitis or impingement, according to the diagnostic criteria of the most recent clinical guidelines, international consensus
Key exclusion criteria (1 listed)
- 1) presence of red-flag symptoms suggesting fractures, dislocations, or complete tendon tears, among others; 2) neurological disorders; 3) other severe shoulder pathologies such as inflammatory arthritis, frozen shoulder, or glenohumeral instability; 4) corticosteroid injections or physical therapy treatment within the last six months; 5) prior shoulder surgery; 6) pregnancy; 7) or cognitive deficits that could limit comprehension of questionnaires or participation in testing.
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 |
|---|---|---|
| Shoulder schoolA therapeutic exercise protocol will be carried out, consisting of 2 sessions per week for 8 weeks, supervised and guided by a physiotherapist. The objective is to improve thoracic mobility, as well as the strength and motor control of the scapular retractor and protractor muscles (middle and lower trapezius, rhomboids, and serratus anterior) and the rotator cuff. | Other | Shoulder school |
| Standard Care (in control arm)The protocol will include the application of therapeutic ultrasound, TENS, and kinesitherapy which will be applied through classic shoulder mobility exercises. | Other | Standard protocol |
Primary outcome
Pain intensity measured with visual analogue scale
Time frame: From enrollment through treatment completion and up to 3 months of follow-up
Visual analogue scale is a subjective pain intensity measurement tool in which subjects are asked to indicate their perceived pain intensity on a 10 cm line. Patients will be informed that the left end of the scale represents "no pain" and the right end represents "the worst pain imaginable." It will be explained that marking closer to the right corresponds to a higher score (10 cm) and greater pain, while marking closer to the left corresponds to a lower score (0 cm) and a better state of health.
4 secondary outcomes
Disability measured with Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: From enrollment through treatment completion and up to 3 months of follow-up
Quality of life measured with EuroQol 5-Dimensions 5-Levels
Time frame: From enrollment through treatment completion and up to 3 months of follow-up
Range of motion measured with inclinometer
Time frame: From enrollment through treatment completion and up to 3 months of follow-up
Isometric strenght measured with isometric dynamometer (Lafayette 01655)
Time frame: From enrollment through treatment completion and up to 3 months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder school in people with Rotator Cuff Related Shoulder Pain, run by University of Valladolid.
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 1 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Jiménez-del-Barrio, PhD (975 12 9166, sandra.jimenez.barrio@uva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured with visual analogue scale (time frame: From enrollment through treatment completion and up to 3 months of follow-up). 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 21 Oct 2026.