Subacromial Impingement SyndromeNCT06778551
Shoulder School: A Multicenter Prospective Randomized Controlled Study
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Subacromial Impingement Syndrome, run by Sandra Jiménez-del-Barrio at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jan 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read more
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
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Control (Standard treatment)
- Keywords
- quality of life, Subacromial impingement syndrome, pain, exercise
- Medical subject headings
- Shoulder Impingement Syndrome, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start23 Jan 2025
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandra Jiménez-del-Barrio
- Sponsor type
- University, hospital or other
- Collaborators
- Sanidad de Castilla y León
- Responsible party
- Sponsor-investigator, Sandra Jiménez-del-Barrio, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778551
- Sponsor's protocol ID
- REF CEIm 3200
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06778551
- Acronym / sponsor ID
- REF CEIm 3200
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- quality of life, Subacromial impingement syndrome, pain, exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sandra Jiménez-del-BarrioUniversity, hospital or other
- Collaborators
- Sanidad de Castilla y León
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONA 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 group | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONA 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 group |
| 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. | Other | Control group |
Primary outcome
Pain intensiy
Time frame: 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
Time frame: 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.
6 secondary outcomes
Disability
Time frame: From enrollment to the end of treatment at 8 weeks
Quality of life
Time frame: From enrollment to the end of treatment at 8 weeks
Scapular stability
Time frame: From enrollment to the end of treatment at 8 weeks
Global rating score
Time frame: At the end of treatment at 8 weeks
Shoulder Joint Mobility
Time frame: From enrollment to the end of treatment at 8 weeks
Isometric muscle strength
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Subacromial Impingement Syndrome, run by Sandra Jiménez-del-Barrio at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensiy (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.