An interventional study of Shoulder school and Standard Care (in control arm) in Rotator Cuff Related Shoulder Pain, sponsored by University of Valladolid. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Valladolid · Not applicable, Interventional, and Treatment
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.
2,646 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 2,309 interventional studies indexed under Motor Activity.
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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
Exclusion Criteria:
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.
Other: Shoulder school
The protocol will include the application of therapeutic ultrasound, TENS, and kinesitherapy which will be applied through classic shoulder mobility exercises.
Other: Standard Care (in control arm)
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.
The protocol will include the application of therapeutic ultrasound, TENS, and kinesitherapy which will be applied through classic shoulder mobility exercises.
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.
Time frame: From enrollment through treatment completion and up to 3 months of follow-up
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.
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
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.
Time frame: 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.
Time frame: 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
Time frame: From enrollment through treatment completion and up to 3 months of follow-up
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Valladolid