Shoulder School: A Multicenter Prospective Randomized Controlled Study

NCT06778551 | Active Not Recruiting DMC

• 1 other identifier: REF CEIm 3200
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Impingement Syndrome

Keywords

quality of life; Subacromial impingement syndrome; pain; exercise

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Disability

  From enrollment to the end of treatment at 8 weeks

• Quality of life

  From enrollment to the end of treatment at 8 weeks

• Scapular stability

  From enrollment to the end of treatment at 8 weeks

• Global rating score

  At the end of treatment at 8 weeks

• Shoulder Joint Mobility

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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.

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

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.

Other: Control (Standard treatment)

Interventions

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.

Exercise group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sandra Jiménez-del-Barrio: lead
• Sanidad de Castilla y León: collaborator

Study Sites (1)

Faculty of Health Sciences

Soria, Soria, 42004, Spain

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Pain; Motor Activity

Interventions

Exercise; Dosage Forms

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD. Sandra Jiménez del Barrio

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: January 23, 2025
• Primary Completion: October 20, 2025
• Study Completion (Estimated): June 20, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)