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

NCT07232511 | Recruiting

• 1 other identifier: 2025-FIS-3945738
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.

  Periprocedural

• 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

  Periprocedural

Secondary Outcomes (4)

• Pressure pain threshold

  Periprocedural

• Exercise tolerance with each setting

  Periprocedural

• Occurrence of adverse effects

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

• Surface electromyography

  Periprocedural

Study Arms (4)

Resistance exercise with low blood occlusion

EXPERIMENTAL

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

Device: Resistance exercise with low AOP

Resistance exercise with moderate blood occlusion

EXPERIMENTAL

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

Device: Resistance exercise with moderate BFR

Resistance exercise with high blood occlusion

EXPERIMENTAL

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

Device: Resistance exercise with high BFR

Resistance exercise with sham blood flow restriction

SHAM COMPARATOR

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

Device: Resistance exercise with sham BFR

Interventions

Resistance exercise with low AOP 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 low blood occlusion

Resistance exercise with moderate 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.

Resistance exercise with moderate blood occlusion

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

Resistance exercise with high blood occlusion

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

Resistance exercise with sham 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:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy, University of Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Adrian Escriche-Escuder, PhD

  University of Valencia

  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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 18, 2025
• Study Start: March 5, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

ES (1)