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

NCT07324993 | Not Yet Recruiting

• 1 other identifier: 2025-FIS-3960959
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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

Keywords

blood flow restriction; exercise; rotator cuff-related shoulder pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity during movement (Visual Analogue Scale, 0-10)

  Pain intensity perceived on a Visual Analogue Scale during movement (flexion and abduction movement without load), being 0 no pain and 10 the worst pain imaginable.

  Baseline, 2 weeks, and 4 weeks.

Secondary Outcomes (9)

• Pain intensity at rest (Visual Analogue Scale, 0-10)

  Baseline, 2 weeks, and 4 weeks.

• Pressure pain threshold

  Before the session, immediately after, and 1 hour post-intervention

• Kinesiophobia

  Baseline, 2 weeks, and 4 weeks.

• Occurrence of adverse effects

  Immediately after the intervention, 1 hour, 6 hours, 24 hours.

• Pain Catastrophizing

  Baseline, 2 weeks, and 4 weeks.

Study Arms (2)

Low resistance exercise with blood occlusion

EXPERIMENTAL

Eight sessions of exercise during 4 weeks, 30% repetition maximum, and 50% blood occlusion

Device: Resistance exercise with BFR

Low resistance exercise without blood flow restriction

ACTIVE COMPARATOR

Eight sessions of exercise during 4 weeks, 30% repetition maximum, without blood occlusion

Procedure: Resistance exercise without BFR

Interventions

Resistance exercise with BFR 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 with blood occlusion

Resistance exercise without BFR 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.

Low resistance exercise without blood flow restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Adrián Escriche-Escuder, PhD

  Universitat de València

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Escriche-Escuder, PhD

CONTACT

+34 963 98 38 55; adrian.escriche@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share