- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Manar Tarek Abdelnaser, Demonstrator
- Telefonnummer: +2001226874389 +2001553437534
- E-mail: tm610587@gmail.com
Studiesteder
-
-
-
Rāshid, Egypten
- Rekruttering
- Faculty of physical therapy, Rashid university
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
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.
|
|
Eksperimentel: 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
|
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.
|
|
Aktiv komparator: 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.
|
: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder Pain
Tidsramme: 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.
|
Baseline, week 2, week 4
|
|
Shoulder Function (SPADI)
Tidsramme: 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.
|
Baseline, Week 2, Week 4
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Range of Motion (ROM)
Tidsramme: Baseline, Week 2, Week 4
|
Active shoulder ROM (flexion, abduction) will be measured using a Inclinometer by a physical therapist.
This assesses the interventions' effect on mobility.
|
Baseline, Week 2, Week 4
|
|
Muscle Strength
Tidsramme: Baseline, Week 2, Week 4
|
Shoulder abduction and external rotation strength will be measured using a hand-held dynamometer.
The outcome evaluates changes in muscular capacity after the intervention
|
Baseline, Week 2, Week 4
|
|
Shoulder proprioception
Tidsramme: Baseline, Week 4
|
Measures the participant's ability to actively reproduce specific shoulder angles.
Assesses improvement in sensorimotor control after intervention.
|
Baseline, Week 4
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Enas Fawzy Youssf, Professor of physical therapy, Cairo University
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BFR vs pilates in SAIS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Subacromial Impingement Syndrome
-
Lokman Hekim UniversityAfsluttetSubacromial Impingement Syndrome | Skulderimpingementsyndrom | Rotator Cuff Impingement SyndromeTyrkiet (Türkiye)
-
Mahidol UniversityAfsluttetSubacromial Impingement Syndrome | Skulderimpingementsyndrom | Subakromielt smertesyndrom | Subakromial impingement | Impingement syndrom, skulderIndonesien
-
Sevgi Medical CenterAfsluttetSubacromial Impingement Syndrome | Subakromial impingementKalkun
-
University of HailTaif UniversityAfsluttetImpingement syndrom af ankelSaudi Arabien
-
California State University, Long BeachTilmelding efter invitationSubacromial Impingement Syndrome | Rotator Cuff syndrom | Apikal skuldersmerteForenede Stater
-
Sacred Heart UniversityNova Southeastern UniversityAfsluttetSubacromial Impingement Syndrome | Subakromial impingement
-
Kutahya Health Sciences UniversityRekrutteringSubacromial Impingement SyndromeKalkun
-
Acibadem UniversityYeditepe UniversityAfsluttetSubacromial Impingement SyndromeKalkun
-
Taif UniversityAfsluttetSubacromial Impingement SyndromeSaudi Arabien
-
Medipol UniversityAktiv, ikke rekrutterende
Kliniske forsøg med Low load resistance training with BFR
-
University of LjubljanaUniversity of Primorska; University Medical Centre LjubljanaAfsluttetKnæskader | Knækirurgi | Arthrogen muskelhæmningSlovenien
-
The Hong Kong Polytechnic UniversityRekrutteringKronisk slagtilfældeHong Kong