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

NCT07608809 | Recruiting

• 1 other identifier: BFR vs pilates in SAIS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 2, Week 4

Secondary Outcomes (3)

• Range of Motion (ROM)

  Baseline, Week 2, Week 4

• Muscle Strength

  Baseline, Week 2, Week 4

• Shoulder proprioception

  Baseline, Week 4

Study Arms (3)

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

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

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.

Other: Cool's shoulder exercises

Interventions

Low load resistance training with BFR OTHER

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.

Low-load resistance training with BFR

Pilates exercises OTHER

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.

Pilates exercises group

Cool's shoulder exercises OTHER

: 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

Control group

Eligibility Criteria

• Age: 18 Weeks - 55 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• \. pain level should be ranged from 3 to 8 on the VAS .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Rashid university

Rāshid, Egypt

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Enas Fawzy Youssf, Professor of physical therapy

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manar Tarek Abdelnaser, Demonstrator

CONTACT

+2001553437534; tm610587@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: May 23, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

EG (1)