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

NCT ID: NCT07232511

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Rotator Cuff Related Shoulder Pain

Study Design

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

Study Groups

Resistance exercise with low blood occlusion

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

Group Type: EXPERIMENTAL

Resistance exercise with low AOP

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 30% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.

Resistance exercise with moderate blood occlusion

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

Group Type: EXPERIMENTAL

Resistance exercise with moderate 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.

Resistance exercise with high blood occlusion

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

Group Type: EXPERIMENTAL

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

Resistance exercise with sham blood flow restriction

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

Group Type: SHAM_COMPARATOR

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

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• 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

• 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

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrian Escriche-Escuder, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Central Contacts

Adrian Escriche-Escuder, PhD

Role: CONTACT

adrian.escriche@uv.es

+34 963 98 38 55

Other Identifiers

2025-FIS-3945738

Identifier Type: -

Identifier Source: org_study_id