Subacromial Impingement SyndromeNCT07608809
Effect of Blood Flow Restriction Training Versus Pilates on Shoulder Impingement Syndrome
A study testing Low load resistance training with BFR, Pilates exercises and Cool's shoulder exercises in people with Subacromial Impingement Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Subacromial impingement syndrome (SAIS) is the most common cause of shoulder pain, accounting for a large proportion of musculoskeletal complaints. It is characterized by narrowing of the subacromial space, leading to pain, weakness, limited range of motion, and impaired shoulder function. Read more about this study
- Who is it for?
- Ages 18 to 55 weeks
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Low load resistance training with BFR, Pilates exercises and Cool's shoulder exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2026to 15 Jan 2027
- 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 to 55 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 - Age ranging from 18 to 55 years of both genders, with BMI ranging 18.5 to 29.9 Kg/m2 2. Clinically diagnosed with SIS, based on having ≥ 3 positive results of the following; pain during shoulder elevation and overhead activities, the painful arc, Neer impingement, Hawkins-Kennedy impingement, external rotation resistance, or empty can tests 3. Symptoms duration between 4 to 12 weeks (subacute and chronic phases)
- 4. pain level should be ranged from 3 to 8 on the VAS .
Who cannot join
- 1 - History of shoulder surgery, traumatic injury or systematic diseases 2. Any cervical problems as cervical disc \& any patient with radioculopathy. 3. Pregnancy. 4. Acute stage of subacromial impingement syndrome 5. Full thickness tear confirmed by the orthopaedist. 6. subjects shouldn't receive any physical therapy sessions in the past 3 months to minimize any confounders to treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy, Rashid university
Rāshid
About this study
Official title: Blood Flow Restriction Versus Pilates Exercises in Treatment of Patients With Subacromial Impingement Syndrome
Subacromial impingement syndrome (SAIS) is the most common cause of shoulder pain, accounting for a large proportion of musculoskeletal complaints. It is characterized by narrowing of the subacromial space, leading to pain, weakness, limited range of motion, and impaired shoulder function. Muscle weakness, especially of the rotator cuff and scapular stabilizers, plays a major role in its pathomechanics.
Although conventional strengthening exercises are effective, they are often delayed until pain subsides, which may prolong recovery. Blood Flow Restriction (BFR) training and Pilates exercises have recently emerged as promising approaches that may enhance strength and function during earlier, painful stages of rehabilitation. However, limited research has compared both interventions in patients with SAIS. Therefore, this study aims to compare the effectiveness of BFR training versus Pilates exercises, in addition to conventional therapy, on pain, function, range of motion, muscle strength, and proprioception in patients with painful SAIS.
Read the detailed description
Shoulder pain is one of the most prevalent musculoskeletal complaints, ranking as the third most common condition encountered in primary care settings. Among the various causes of shoulder pain, subacromial impingement syndrome (SAIS) represents the most frequent diagnosis, accounting for nearly half to two-thirds of reported shoulder pain cases. SAIS is characterized by narrowing of the subacromial space, resulting in compression and irritation of soft tissues such as the supraspinatus tendon, long head of biceps tendon, subacromial bursa, and joint capsule.
Clinically, patients with SAIS present with pain during overhead activities, muscle weakness, and a painful arc of motion, particularly between 60° and 120° of shoulder elevation. Weakness of the rotator cuff and scapular stabilizing muscles contributes significantly to altered scapulohumeral rhythm and compromised glenohumeral stability. Consequently, muscle strengthening is considered a cornerstone in rehabilitation programs.
Traditional resistance training typically requires moderate to high loads (around 60% of one-repetition maximum) to achieve strength gains. However, during the painful phases of SAIS, patients may not tolerate heavy loading, leading to delayed initiation of strengthening exercises and prolonged recovery time. Therefore, alternative strengthening strategies that minimize mechanical stress while promoting muscle adaptation are needed.
Blood Flow Restriction (BFR) training is a technique that applies controlled external pressure to partially restrict arterial inflow and venous outflow, enabling strength gains with low-load resistance (approximately 20-30% of 1RM). It stimulates metabolic stress and anabolic pathways, enhancing muscle hypertrophy and strength while reducing joint stress.
Pilates exercises, on the other hand, are mind-body exercises based on principles of control, concentration, centering, precision, breathing, and flow. They emphasize neuromuscular control, core stability, scapular alignment, and coordinated movement patterns. Previous studies have demonstrated beneficial effects of Pilates in improving pain, function, and muscle strength in various musculoskeletal disorders, including shoulder conditions.
Despite the promising effects of both BFR and Pilates, limited evidence directly compares their effectiveness in shoulder rehabilitation, particularly in patients with SAIS. To the author's knowledge, no previous study has directly compared these two interventions in managing painful subacromial impingement syndrome. Therefore, this study aims to evaluate and compare the effects of BFR training and Pilates exercises, in addition to conventional therapy, on pain intensity, functional disability, shoulder range of motion, muscle strength, and proprioception in patients with SAIS.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Low load resistance training with BFR, Pilates exercises, Cool's shoulder exercises
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low load resistance training with BFROther
Participants will perform low-load resistance training combined with Blood Flow Restriction (BFR) 3 times per week for 4 weeks. Each session will last 45 minutes and include exercises for shoulder muscles with cuffs applied to the upper arm to partially restrict blood flow, ensuring safety and gradual load progression.
Pilates exercisesOther
Participants will perform supervised Pilates exercises 3 times per week for 4 weeks. Each session will last 45 minutes and include mat-based exercises, resistance band work, and equipment-assisted movements targeting shoulder mobility, stability, and posture. Exercises will be progressively adjusted according to participant tolerance and performance.
Cool's shoulder exercisesOther
: Participants will perform standard Cool's exercises 3 times per week for 4 weeks. Each session will last 45 minutes and focus on targeted shoulder rehabilitation movements designed to improve flexibility, muscle activation, and pain reduction. Exercises will be supervised and progressively adapted based on participant performance
| Study group | Role | What they receive |
|---|---|---|
| Low-load resistance training with BFR | Experimental | Participants will perform low-load resistance training combined with Blood Flow Restriction (BFR) 3 times per week for 4 weeks. Each session will last 45 minutes and include exercises for shoulder muscles with cuffs applied to the upper arm to partially restrict blood flow, ensuring safety and gradual load progression combined with cool's exercises Receives: Other: Low load resistance training with BFR |
| Pilates exercises group | Experimental | Participants will perform supervised Pilates exercises 3 times per week for 4 weeks. Each session will last 45 minutes and include mat-based exercises, resistance band work, and equipment-assisted movements targeting shoulder mobility, stability, and posture. Exercises will be progressively adjusted according to participant tolerance and performance combined with cool's exercises Receives: Other: Pilates exercises |
| Control group | Active comparator | Participants will perform standard Cool's exercises 3 times per week for 4 weeks. Each session will last 45 minutes and focus on targeted shoulder rehabilitation movements designed to improve flexibility, muscle activation, and pain reduction. Exercises will be supervised and progressively adapted based on participant performance. Receives: Other: Cool's shoulder exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain
Pain intensity will be measured using the Visual Analogue Scale, a 0-10 scale where 0 indicates no pain and 10 indicates worst imaginable pain. Patients will mark their pain at rest and during shoulder activity. This outcome assesses the effectiveness of the interventions in reducing pain.
Measured: Baseline, week 2, week 4
Shoulder Function (SPADI)
Shoulder function will be evaluated using the Shoulder Pain and Disability Index (SPADI), which includes pain and disability subscales. Scores range from 0-100, with higher scores indicating greater disability. This measure evaluates functional improvement after the intervention.
Measured: Baseline, Week 2, Week 4
Secondary outcomes (3)
Range of Motion (ROM)
Active shoulder ROM (flexion, abduction) will be measured using a Inclinometer by a physical therapist. This assesses the interventions' effect on mobility.
Measured: Baseline, Week 2, Week 4
Muscle Strength
Shoulder abduction and external rotation strength will be measured using a hand-held dynamometer. The outcome evaluates changes in muscular capacity after the intervention
Measured: Baseline, Week 2, Week 4
Shoulder proprioception
Measures the participant's ability to actively reproduce specific shoulder angles. Assesses improvement in sensorimotor control after intervention.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start23 May 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Tarek Abdelnaser Abdelmohimen, Cairo University
- Investigators
- Enas Fawzy Youssf, Professor of physical therapy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608809
- Sponsor's protocol ID
- BFR vs pilates in SAIS
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Versus Pilates Exercises in Treatment of Patients With Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT07608809
- Acronym / sponsor ID
- BFR vs pilates in SAIS
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 May 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 27 May 2026 (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 (SAIS) is the most common cause of shoulder pain, accounting for a large proportion of musculoskeletal complaints. It is characterized by narrowing of the subacromial space, leading to pain, weakness, limited range of motion, and impaired shoulder function. Muscle weakness, especially of the rotator cuff and scapular stabilizers, plays a major role in its pathomechanics.
Although conventional strengthening exercises are effective, they are often delayed until pain subsides, which may prolong recovery. Blood Flow Restriction (BFR) training and Pilates exercises have recently emerged as promising approaches that may enhance strength and function during earlier, painful stages of rehabilitation. However, limited research has compared both interventions in patients with SAIS. Therefore, this study aims to compare the effectiveness of BFR training versus Pilates exercises, in addition to conventional therapy, on pain, function, range of motion, muscle strength, and proprioception in patients with painful SAIS.
Detailed description
Shoulder pain is one of the most prevalent musculoskeletal complaints, ranking as the third most common condition encountered in primary care settings. Among the various causes of shoulder pain, subacromial impingement syndrome (SAIS) represents the most frequent diagnosis, accounting for nearly half to two-thirds of reported shoulder pain cases. SAIS is characterized by narrowing of the subacromial space, resulting in compression and irritation of soft tissues such as the supraspinatus tendon, long head of biceps tendon, subacromial bursa, and joint capsule.
Clinically, patients with SAIS present with pain during overhead activities, muscle weakness, and a painful arc of motion, particularly between 60° and 120° of shoulder elevation. Weakness of the rotator cuff and scapular stabilizing muscles contributes significantly to altered scapulohumeral rhythm and compromised glenohumeral stability. Consequently, muscle strengthening is considered a cornerstone in rehabilitation programs.
Traditional resistance training typically requires moderate to high loads (around 60% of one-repetition maximum) to achieve strength gains. However, during the painful phases of SAIS, patients may not tolerate heavy loading, leading to delayed initiation of strengthening exercises and prolonged recovery time. Therefore, alternative strengthening strategies that minimize mechanical stress while promoting muscle adaptation are needed.
Blood Flow Restriction (BFR) training is a technique that applies controlled external pressure to partially restrict arterial inflow and venous outflow, enabling strength gains with low-load resistance (approximately 20-30% of 1RM). It stimulates metabolic stress and anabolic pathways, enhancing muscle hypertrophy and strength while reducing joint stress.
Pilates exercises, on the other hand, are mind-body exercises based on principles of control, concentration, centering, precision, breathing, and flow. They emphasize neuromuscular control, core stability, scapular alignment, and coordinated movement patterns. Previous studies have demonstrated beneficial effects of Pilates in improving pain, function, and muscle strength in various musculoskeletal disorders, including shoulder conditions.
Despite the promising effects of both BFR and Pilates, limited evidence directly compares their effectiveness in shoulder rehabilitation, particularly in patients with SAIS. To the author's knowledge, no previous study has directly compared these two interventions in managing painful subacromial impingement syndrome. Therefore, this study aims to evaluate and compare the effects of BFR training and Pilates exercises, in addition to conventional therapy, on pain intensity, functional disability, shoulder range of motion, muscle strength, and proprioception in patients with SAIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-load resistance training with BFR | Experimental | Other: Low load resistance training with BFRParticipants will perform low-load resistance training combined with Blood Flow Restriction (BFR) 3 times per week for 4 weeks. Each session will last 45 minutes and include exercises for shoulder muscles with cuffs applied to the upper arm to partially restrict blood flow, ensuring safety and gradual load progression combined with cool's exercises |
| Pilates exercises group | Experimental | Other: Pilates exercisesParticipants will perform supervised Pilates exercises 3 times per week for 4 weeks. Each session will last 45 minutes and include mat-based exercises, resistance band work, and equipment-assisted movements targeting shoulder mobility, stability, and posture. Exercises will be progressively adjusted according to participant tolerance and performance combined with cool's exercises |
| Control group | Active comparator | Other: Cool's shoulder exercisesParticipants will perform standard Cool's exercises 3 times per week for 4 weeks. Each session will last 45 minutes and focus on targeted shoulder rehabilitation movements designed to improve flexibility, muscle activation, and pain reduction. Exercises will be supervised and progressively adapted based on participant performance. |
Who may qualify
- Ages
- 18 to 55 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1 - Age ranging from 18 to 55 years of both genders, with BMI ranging 18.5 to 29.9 Kg/m2 2. Clinically diagnosed with SIS, based on having ≥ 3 positive results of the following; pain during shoulder elevation and overhead activities, the painful arc, Neer impingement, Hawkins-Kennedy impingement, external rotation resistance, or empty can tests 3. Symptoms duration between 4 to 12 weeks (subacute and chronic phases)
- 4. pain level should be ranged from 3 to 8 on the VAS .
Key exclusion criteria (1 listed)
- 1 - History of shoulder surgery, traumatic injury or systematic diseases 2. Any cervical problems as cervical disc \& any patient with radioculopathy. 3. Pregnancy. 4. Acute stage of subacromial impingement syndrome 5. Full thickness tear confirmed by the orthopaedist. 6. subjects shouldn't receive any physical therapy sessions in the past 3 months to minimize any confounders to treatment.
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 |
|---|---|---|
| Low load resistance training with BFRParticipants will perform low-load resistance training combined with Blood Flow Restriction (BFR) 3 times per week for 4 weeks. Each session will last 45 minutes and include exercises for shoulder muscles with cuffs applied to the upper arm to partially restrict blood flow, ensuring safety and gradual load progression. | Other | Low-load resistance training with BFR |
| Pilates exercisesParticipants will perform supervised Pilates exercises 3 times per week for 4 weeks. Each session will last 45 minutes and include mat-based exercises, resistance band work, and equipment-assisted movements targeting shoulder mobility, stability, and posture. Exercises will be progressively adjusted according to participant tolerance and performance. | Other | Pilates exercises group |
| Cool's shoulder exercises: Participants will perform standard Cool's exercises 3 times per week for 4 weeks. Each session will last 45 minutes and focus on targeted shoulder rehabilitation movements designed to improve flexibility, muscle activation, and pain reduction. Exercises will be supervised and progressively adapted based on participant performance | Other | Control group |
Primary outcome
Shoulder Pain
Time frame: Baseline, week 2, week 4
Pain intensity will be measured using the Visual Analogue Scale, a 0-10 scale where 0 indicates no pain and 10 indicates worst imaginable pain. Patients will mark their pain at rest and during shoulder activity. This outcome assesses the effectiveness of the interventions in reducing pain.
Shoulder Function (SPADI)
Time frame: Baseline, Week 2, Week 4
Shoulder function will be evaluated using the Shoulder Pain and Disability Index (SPADI), which includes pain and disability subscales. Scores range from 0-100, with higher scores indicating greater disability. This measure evaluates functional improvement after the intervention.
3 secondary outcomes
Range of Motion (ROM)
Time frame: Baseline, Week 2, Week 4
Muscle Strength
Time frame: Baseline, Week 2, Week 4
Shoulder proprioception
Time frame: Baseline, Week 4
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 27 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Enas Fawzy Youssf, Professor of physical therapy principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low load resistance training with BFR, Pilates exercises and Cool's shoulder exercises in people with Subacromial Impingement Syndrome, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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 Egypt. 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?
Contact Manar Tarek Abdelnaser, Demonstrator (+2001553437534 ext. +2001226874389, tm610587@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain (time frame: Baseline, week 2, week 4). 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 27 May 2026.