Implementation of Shoulder School in Albania

NCT07885878 — Not applicable, Not yet recruiting, 50 participants, University of Valladolid

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Implementation of Shoulder School in Albania. A Multicenter Prospective Randomized Clinical Trial

Registry	NCT07885878
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	50 (Estimated)
Sponsor	University of Valladolid (Other); collaborators: European University of Tirana
Conditions	Rotator Cuff Related Shoulder Pain
Interventions	Shoulder school, Standard Care (in control arm) (Other)
Dates	start 2026-11-01 (estimated), primary completion 2028-03-01 (estimated), completion 2028-03-01 (estimated), first posted 2026-10-21, last updated 2026-10-21

-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.

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Shoulder school	Experimental	Other: Shoulder school	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 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.

Shoulder school (Other): 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.

+Outcome measures

Primary outcomes

Pain intensity measured with visual analogue scale [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.

Secondary outcomes

Disability measured with Disabilities of the Arm, Shoulder and Hand Questionnaire [From enrollment through treatment completion and up to 3 months of follow-up]: 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.
Quality of life measured with EuroQol 5-Dimensions 5-Levels [From enrollment through treatment completion and up to 3 months of follow-up]: 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.
Range of motion measured with inclinometer [From enrollment through treatment completion and up to 3 months of follow-up]: 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.
Isometric strenght measured with isometric dynamometer (Lafayette 01655) [From enrollment through treatment completion and up to 3 months of follow-up]: 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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.