Exercise-induced Hypoalgesia Effects of Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain

NCT07232511 · tracked via the Priya Life Science Spain tracker

Sponsor

University of Valencia

Phase

Not applicable

Started

2026-03-05

Last updated

2026-05-04

Condition(s) studied

Rotator Cuff Related Shoulder Pain

Investigational drug(s) / intervention(s)

Resistance exercise with low AOPResistance exercise with moderate BFRResistance exercise with high BFRResistance exercise with sham BFR

Resistance exercise with low AOP: 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 30% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.

Resistance exercise with moderate 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.

Resistance exercise with high 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 70% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.

Resistance exercise with sham 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 sham blood flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

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

Primary outcome measure(s)

Pain intensity at rest (Visual Analogue Scale, 0-10) — Periprocedural
Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.
Pain intensity during movement (Visual Analogue Scale, 0-10) — Periprocedural
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

Trial sites (1)

Facility	City	Region	Status
Faculty of Physiotherapy, University of Valencia	Valencia	Valencia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07232511 on ClinicalTrials.gov ↗ ← All trials in Spain