Exercise-induced Hypoalgesia Effects of 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 moderate BFR; Device: Resistance exercise with sham BFR; Device: Resistance exercise with low AOP; Device: Resistance exercise with high BFR

Study type: Interventional

Funder types: Other

Identifiers

NCT07232511

2025-FIS-3945738

Details and patient eligibility

About

This study aims to compare the effects of blood flow restricted (BFR) exercise and to examine the differences between various BFR protocols on acute pain reduction in individuals with rotator cuff-related shoulder pain, as well as the exercise tolerance at each intensity and occlusion setting. There are four exercise modalities corresponding to different combinations of intensity (%RM) and percentage of occlusion (%AOP): 1) 30% RM and 30% AOP; 2) 30% RM and 50% AOP; 3) 30% RM and 70% AOP; 4) 30% RM and BFR placebo (cuff without pressure).

All participants will complete one session of each of the four exercise modalities, analyzing the variables studied in each for subsequent analysis and comparison.

Enrollment: 30 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

• History of shoulder trauma or surgery
• Pain of such intensity that it is impossible to perform 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 arm drop test)
• Suspected frozen shoulder (50% reduction or more than 30° loss in 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 injections in the last 6 weeks
• Presence of diseases such as inflammatory arthritis, neurological diseases, fibromyalgia, malignant tumors, or polymyalgia rheumatica
• Presence of more than one risk factor for thromboembolism
• Participation in upper limb exercise programs in the last month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 4 patient groups

Resistance exercise with low blood occlusion

Experimental group

Description:

A single session of exercise, 30% repetition maximum, and 30% blood occlusion

Treatment:

Device: Resistance exercise with low AOP

Resistance exercise with moderate blood occlusion

Experimental group

Description:

A single session of exercise, 30% repetition maximum, and 50% blood occlusion

Treatment:

Device: Resistance exercise with moderate BFR

Resistance exercise with high blood occlusion

Experimental group

Description:

A single session of exercise, 30% repetition maximum, and 70% blood occlusion

Treatment:

Device: Resistance exercise with high BFR

Resistance exercise with sham blood flow restriction

Sham Comparator group

Description:

A single session of exercise, 30% repetition maximum, and without blood restriction (cuff applied without pressure)

Treatment:

Device: Resistance exercise with sham BFR