Shoulder School: A Multicenter Prospective Randomized Controlled Study

Not Applicable

Active, not recruiting

• Conditions: Subacromial Impingement Syndrome

• Registration Number: NCT06778551
• Lead Sponsor: Sandra Jiménez-del-Barrio

Brief Summary

Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Patients with SIS present with localized shoulder pain, sometimes nocturnal, which leads to a decrease in shoulder strength and function, significantly affecting their quality of life. Several authors have proposed that reduced scapular movement could be a direct causal mechanism for the symptoms associated with SIS. There is evidence supporting the benefits of passive techniques applied to the scapula and thoracic spine in terms of symptom relief and improved function.

The high healthcare demand from patients with SIS, combined with long waiting lists in physiotherapy, rehabilitation, and trauma services related to this dysfunction, underscores the need for a group-based therapeutic exercise strategy.

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 SIS referred to Primary Care Physiotherapy Units (UFAP), regarding pain, functional capacity, and quality of life.

Methods Design: Single-blind, multicenter, prospective, randomized, controlled non-inferiority study.

Sample: Patients with SIS referred to UFAP. Dependent Variables: Pain, functional capacity, quality of life, joint mobility, scapular function, 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-12
• Study First Submitted QC: 2025-01-12
• Study First Posted: 2025-01-16
• Study Start: 2025-01-23
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-10-20
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Be over 18 years old
• Shoulder pain lasting more than 6 weeks, attributable to rotator cuff tendinopathy or tendinosis, subacromial impingement syndrome, or subacromial pinching, according to the diagnostic criteria of the British Shoulder and Elbow Society. Must meet 2 of the following criteria: painful arc during flexion or abduction, positive Neer test, positive Hawkins-Kennedy test, or pain with resisted movement of external rotation, abduction, or positive Jobe test.
• Ability to understand and complete the evaluation questionnaires

Exclusion Criteria

• History of significant shoulder trauma (fractures, dislocations, complete tears requiring surgery)
• Neurological disorders affecting the shoulder
• Other severe shoulder pathologies (inflammatory arthritis, frozen shoulder, or glenohumeral instability)
• Received corticosteroid injections or physical therapy for the shoulder in the last 6 months
• Referred to another specialized care service, such as surgery, due to SIS
• Pregnancy
• BMI (Body Mass Index) greater than 30 kg/m².

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensiy	From enrollment to the end of treatment at 8 weeks	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.
Physical Function	From enrollment to the end of treatment at 8 weeks	The SPADI (Shoulder Pain and Disability Index) is a questionnaire used to measure shoulder symptoms and function. It consists of 13 questions divided into two categories: pain and activity limitation. It is a self-administered questionnaire where patients respond to the questions using a visual analog scale. A higher score on the questionnaire indicates greater pain and greater restriction in activities.

Secondary Outcome Measures

Name	Time	Method
Global rating score	At the end of treatment at 8 weeks	Global Rating of Change (GROC Scale) is a 15-item scale that assesses the clinical significance that the patient assigns to their outcomes. It allows for the evaluation of the therapeutic value of the proposed techniques.
Shoulder Joint Mobility	From enrollment to the end of treatment at 8 weeks	The painless active range of motion will be measured using a digital inclinometer during flexion, abduction, and internal and external rotation movements.
Isometric muscle strength	From enrollment to the end of treatment at 8 weeks	The strength of internal and external rotation will be assessed with the shoulder at 90º of abduction.
Disability	From enrollment to the end of treatment at 8 weeks	The DASH is one of the most commonly used questionnaires to assess symptoms and function of the upper extremity. This questionnaire considers the level of difficulty experienced in performing physical activities due to upper limb problems and the severity of symptoms. It consists of 30 items divided into three sections: 11 general questions, 4 related to work, and 4 related to sports. Each item offers 5 response options, ranging from 1 (representing no difficulty) to 5 (representing complete inability to perform the activity).
Quality of life	From enrollment to the end of treatment at 8 weeks	WORC Questionnaire (Western Ontario Rotator Cuff Index) is a questionnaire designed to assess the impact of treatment on quality of life in relation to rotator cuff dysfunction. It includes 21 items covering physical symptoms, sports and recreational activities, work-related activities, lifestyle, and emotional aspects.
Scapular stability	From enrollment to the end of treatment at 8 weeks	The lateral scapular slide test is a functional assessment that measures scapular mobility in different arm positions. This test evaluates the distance between the inferior angle of the scapula and the corresponding spinal spinous process. It is performed in three positions: arms at the sides of the body, hands on the waist, and shoulders at 90° in internal rotation.

Trial Locations

Locations (1)

Faculty of Health Sciences; 🇪🇸 Soria, Spain