Clinical Trial

Shoulder School: A Multicenter Prospective Randomized Controlled Study

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated June 12, 2025 (before its estimated October 20, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-12; most recent amendment 2025-06-11.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-06-11
Trial Details
NCT Number NCT06778551
Lead Sponsor Sandra Jiménez-del-Barrio
Collaborators: Sanidad de Castilla y León
Conditions Subacromial Impingement Syndrome
Enrollment 40 participants
Start Date 2025-01-23
Primary Completion 2025-10-20 (estimated)
Study Completion 2026-06-20 (estimated)
Updated on ClinicalTrials.gov 2025-06-12