Clinical trial NCT06778551: Shoulder School: A Multicenter Prospective Randomized Controlled Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: quality of life
Subacromial impingement syndrome
pain
exercise
Lead sponsor: University of Valladolid
Sponsor class: OTHER
Collaborators: name: Sanidad de Castilla y León
First posted: 2025-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensiy
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Physical Function
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Disability
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Quality of life
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Scapular stability
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Global rating score
timeFrame: At the end of treatment at 8 weeks
measure: Shoulder Joint Mobility
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Isometric muscle strength
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Faculty of Health Sciences
Study officials:
References: