Effects of a 4-week Low-intensity Training With Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resistance exercise with BFR, Resistance exercise without BFR.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Related Shoulder Pain. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Analysis of the Effects of a 4-week Low-intensity Training With and Without Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain
Overview
This study aims to analyze the effects of 4 weeks of low-intensity exercise with and without blood flow restriction (BFR) on pain, fear of movement, catastrophizing about pain, strength, and disability in a population with rotator cuff-related shoulder pain. There are two modalities corresponding to the same exercises under different blood flow restriction conditions: 1) 3 low-intensity exercises (30% 1RM) with BFR (50% AOP); 2) 3 low-intensity exercises (30% 1RM) without BFR. Participants will be randomly assigned to one of two groups and will undergo a 4-week intervention. The variables of interest will be assessed in each group for subsequent analysis and comparison.
Interventions
- Device Resistance exercise with BFR
Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 50% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises. - Procedure Resistance exercise without BFR
Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a without flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.
Primary outcome measures
- Pain intensity during movement (Visual Analogue Scale, 0-10) [Time frame: Baseline, 2 weeks, and 4 weeks.]
Secondary outcome measures (9)
- Pain intensity at rest (Visual Analogue Scale, 0-10) [Time frame: Baseline, 2 weeks, and 4 weeks.]
- Pressure pain threshold [Time frame: Before the session, immediately after, and 1 hour post-intervention]
- Kinesiophobia [Time frame: Baseline, 2 weeks, and 4 weeks.]
- Occurrence of adverse effects [Time frame: Immediately after the intervention, 1 hour, 6 hours, 24 hours.]
- Pain Catastrophizing [Time frame: Baseline, 2 weeks, and 4 weeks.]
- Pain and Disability [Time frame: Baseline, 2 weeks, and 4 weeks.]
- Shoulder Disability [Time frame: Baseline, 2 weeks, and 4 weeks.]
- Muscle Strength [Time frame: Baseline, 2 weeks, and 4 weeks.]
- Satisfaction with methodology [Time frame: 4 weeks.]
Eligibility criteria
Inclusion criteria
- Age between 18 and 65.
- Shoulder symptoms lasting at least 3 months.
- Pain in the proximal anterolateral aspect of the shoulder, aggravated by abduction.
- At least two of the following tests positive: Jobe test, resisted external rotation test, Hawkins-Kennedy test, Neer test, painful arc between 60 and 120 degrees of shoulder abduction.
Exclusion criteria
- Pain of an intensity that prevents performance of the proposed exercises.
- Active arm elevation less than 90 degrees.
- Clinical signs of a complete tear (positive delayed external and internal rotation sign and positive drop arm test).
- Suspected frozen shoulder (50% reduction or more than 30° loss of passive shoulder external rotation).
- Primary diagnosis of shoulder instability or acromioclavicular pathology.
- Shoulder pain due to primary involvement in the cervical or thoracic region
- Corticosteroid injection within the last 6 weeks.
- Presence of diseases such as inflammatory arthritis, neurological diseases, fibromyalgia, malignant tumors, or polymyalgia rheumatica.
- Presence of comorbidities that increase cardiovascular risk, such as hypertension, diabetes, or heart failure.
- Presence of more than one thromboembolism risk factor (obesity, history of thrombosis, prolonged immobilization, recent surgery, use of contraceptives, etc.).
- Presence of active skin lesions in the area where the sleeve will be placed, recent scars or burns, or chronic dermatological diseases that compromise skin integrity,
- Participation in upper limb exercise programs in the last month.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07324993 · 2025-FIS-3960959