CClinicalTrials.gg
RecruitingNCT07608809Updated May 27, 2026

Effect of Blood Flow Restriction Training Versus Pilates on Shoulder Impingement Syndrome

An interventional study of Low load resistance training with BFR and Pilates exercises in Subacromial Impingement Syndrome, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Weeks to 55 Weeks. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Weeks to 55 Weeks
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Subacromial Impingement Syndrome
03

In context

Shoulder Impingement Syndrome

304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.

This study's planned enrollment of 48 is below the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.

Browse Shoulder Impingement Syndrome studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Weeks to 55 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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 .

Exclusion criteria

Exclusion Criteria:

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Low-load resistance training with BFR

    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

    Other: Low load resistance training with BFR

  • Experimental
    Pilates exercises group

    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

    Other: Pilates exercises

  • Active comparator
    Control group

    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: Cool's shoulder exercises

Interventions

  • OtherLow load resistance training with BFR

    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.

  • OtherPilates exercises

    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.

  • OtherCool'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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, week 2, week 4

  2. 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.

    Time frame: Baseline, Week 2, Week 4

Secondary outcomes

  1. 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.

    Time frame: Baseline, Week 2, Week 4

  2. 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

    Time frame: Baseline, Week 2, Week 4

  3. Shoulder proprioception

    Measures the participant's ability to actively reproduce specific shoulder angles. Assesses improvement in sensorimotor control after intervention.

    Time frame: Baseline, Week 4

07

Study locations

1 of 1 sites recruiting
  • Faculty of physical therapy, Rashid university
    Rāshid, Egypt
    Recruiting
08

References and documents

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07608809
Lead sponsor
Cairo University
Responsible party
Manar Tarek Abdelnaser Abdelmohimen (Demonstrator, Cairo University) — Principal investigator
First posted
May 27, 2026
Start date
May 23, 2026 (estimated)
Primary completion
Dec 15, 2026 (estimated)
Completion
Jan 15, 2027 (estimated)
Last update
May 27, 2026

Study contacts

Manar Tarek Abdelnaser, Demonstrator
Contact
tm610587@gmail.com
+2001553437534 ext. +2001226874389
Enas Fawzy Youssf, Professor of physical therapy
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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