Shoulder School: A Multicenter Prospective Randomized Controlled Study

Condition(s) studied

Investigational drug(s) / intervention(s)

EXERCISE TRAINING WITH OR WITHOUT MEDICATION: 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.

Control (Standard treatment): The protocol will include the application of therapeutic ultrasound. For this application, ultrasound gel will be used to reduce friction and improve the transmission of waves. Using a 5 cm² transducer, pulsed ultrasound will be applied at a frequency of 3 MHz and an intensity of 1 W/cm² for 10 minutes. Patients will be informed that they should not feel any sensation during the procedure, and if they do, the intensity will be reduced. Finally, kinesitherapy will be applied through classic shoulder mobility exercises.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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