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| Name | Class |
|---|---|
| Sanidad de Castilla y León | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | 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. |
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| Control group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATION | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensiy | 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. | From enrollment to the end of treatment at 8 weeks |
| Physical Function | 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. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Sciences | Soria | Soria | 42004 | Spain |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| D010146 | Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Control (Standard treatment) | Other | 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. |
|
| From enrollment to the end of treatment at 8 weeks |
| Quality of life | 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. | From enrollment to the end of treatment at 8 weeks |
| Scapular stability | 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. | From enrollment to the end of treatment at 8 weeks |
| Global rating score | 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. | At the end of treatment at 8 weeks |
| Shoulder Joint Mobility | The painless active range of motion will be measured using a digital inclinometer during flexion, abduction, and internal and external rotation movements. | From enrollment to the end of treatment at 8 weeks |
| Isometric muscle strength | The strength of internal and external rotation will be assessed with the shoulder at 90º of abduction. | From enrollment to the end of treatment at 8 weeks |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |