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

Differences in Exercise-induced Hypoalgesia After a Session With Different Blood Flow Restriction Protocols in People With Rotator Cuff-related Shoulder Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Related Shoulder Pain
• Intervention / Treatment: Device: Resistance exercise with low AOP; Device: Resistance exercise with moderate BFR; Device: Resistance exercise with high BFR; Device: Resistance exercise with sham BFR

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrian Escriche-Escuder, PhD; Phone Number: +34 963 98 38 55; Email: adrian.escriche@uv.es

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46010
      • Recruiting
      • Faculty of Physiotherapy, University of Valencia
      • Contact: Adrian Escriche-Escuder; Phone Number: 963983853; Email: dep.fisioterapia@uv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance exercise with low blood occlusion; A single session of exercise, 30% repetition maximum, and 30% blood occlusion	Device: 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.
Experimental: Resistance exercise with moderate blood occlusion; A single session of exercise, 30% repetition maximum, and 50% blood occlusion	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.
Experimental: Resistance exercise with high blood occlusion; A single session of exercise, 30% repetition maximum, and 70% blood occlusion	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.
Sham Comparator: Resistance exercise with sham blood flow restriction; A single session of exercise, 30% repetition maximum, and without blood restriction (cuff applied without pressure)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain threshold	Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer	Periprocedural
Exercise tolerance with each setting	Exercise tolerance with each setting according to the following 5-point scale: well tolerated, tolerated, neutral, poorly tolerated, not tolerated.	Periprocedural
Occurrence of adverse effects	Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report.	Immediately after the intervention, 1 hour, 6 hours, 24 hours
Surface electromyography	Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)	Periprocedural

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Adrian Escriche-Escuder, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: exercise; blood flow restriction; rotator cuff-related shoulder pain
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 2025-FIS-3945738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data that support the findings of this study will be available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No