Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06778551
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shoulder School: A Multicenter Prospective Randomized Controlled Study
Sponsor:
Sandra Jiménez-del-Barrio
Organization:
Study Overview
Official Title:
Effectiveness of an Exercise Program Focused on the Thoracic Spine, Scapular Region, and Shoulder in Patients With Subacromial Impingement: A Multicenter Prospective Randomized Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: