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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07608809
Effect of Blood Flow Restriction Training Versus Pilates on Shoulder Impingement Syndrome
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Manar Tarek Abdelnaser, Demonstrator
- Número de teléfono: +2001226874389 +2001553437534
- Correo electrónico: tm610587@gmail.com
Ubicaciones de estudio
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Rāshid, Egipto
- Reclutamiento
- Faculty of physical therapy, Rashid university
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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:
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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
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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.
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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
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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.
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Comparador activo: 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.
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: 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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Shoulder Pain
Periodo de tiempo: Baseline, week 2, week 4
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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.
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Baseline, week 2, week 4
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Shoulder Function (SPADI)
Periodo de tiempo: Baseline, Week 2, Week 4
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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.
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Baseline, Week 2, Week 4
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Range of Motion (ROM)
Periodo de tiempo: Baseline, Week 2, Week 4
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Active shoulder ROM (flexion, abduction) will be measured using a Inclinometer by a physical therapist.
This assesses the interventions' effect on mobility.
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Baseline, Week 2, Week 4
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Muscle Strength
Periodo de tiempo: Baseline, Week 2, Week 4
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Shoulder abduction and external rotation strength will be measured using a hand-held dynamometer.
The outcome evaluates changes in muscular capacity after the intervention
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Baseline, Week 2, Week 4
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Shoulder proprioception
Periodo de tiempo: Baseline, Week 4
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Measures the participant's ability to actively reproduce specific shoulder angles.
Assesses improvement in sensorimotor control after intervention.
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Baseline, Week 4
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Enas Fawzy Youssf, Professor of physical therapy, Cairo University
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BFR vs pilates in SAIS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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