Effects of a 4-week Low-intensity Training With Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain

University of Valencia

Status: Not yet enrolling

Conditions: Rotator Cuff Related Shoulder Pain

Treatments: Device: Resistance exercise with BFR; Procedure: Resistance exercise without BFR

Study type: Interventional

Funder types: Other

Identifiers

NCT07324993

2025-FIS-3960959

Details and patient eligibility

About

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.

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Low resistance exercise with low blood occlusion

Experimental group

Description:

Eight sessions of exercise during 8 weeks, 30% repetition maximum, and 50% blood occlusion

Treatment:

Device: Resistance exercise with BFR

Low resistance exercise without blood flow restriction

Active Comparator group

Description:

Eight sessions of exercise during 8 weeks, 30% repetition maximum, without blood occlusion

Treatment:

Procedure: Resistance exercise without BFR