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

NCT ID: NCT07324993

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2026-11-30

Brief Summary

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.

Conditions

Rotator Cuff Related Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low resistance exercise with low blood occlusion

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

Group Type: EXPERIMENTAL

Resistance exercise with BFR

Intervention Type: DEVICE

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.

Low resistance exercise without blood flow restriction

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

Group Type: ACTIVE_COMPARATOR

Resistance exercise without BFR

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Adrián Escriche Escuder

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrián Escriche-Escuder, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de València

Central Contacts

Adrian Escriche-Escuder, PhD

Role: CONTACT

adrian.escriche@uv.es

+34 963 98 38 55

Other Identifiers

2025-FIS-3960959

Identifier Type: -

Identifier Source: org_study_id