Effects of a 4-week Low-intensity Training With Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain

Analysis of the Effects of a 4-week Low-intensity Training With and Without Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain

This study aims to analyze the effects of 4 weeks of low-intensity exercise with and without blood flow restriction (BFR) on pain, fear of movement, catastrophizing about pain, strength, and disability in a population with rotator cuff-related shoulder pain. There are two modalities corresponding to the same exercises under different blood flow restriction conditions: 1) 3 low-intensity exercises (30% 1RM) with BFR (50% AOP); 2) 3 low-intensity exercises (30% 1RM) without BFR.

Participants will be randomly assigned to one of two groups and will undergo a 4-week intervention. The variables of interest will be assessed in each group for subsequent analysis and comparison.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Related Shoulder Pain
• Intervention / Treatment: Device: Resistance exercise with BFR; Procedure: Resistance exercise without BFR

• Study Type: Interventional
• Enrollment (Estimated): 34
• 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

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:

• Pain of an intensity that prevents performance of 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 drop arm test).
• Suspected frozen shoulder (50% reduction or more than 30° loss of 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 injection within the last 6 weeks.
• Presence of diseases such as inflammatory arthritis, neurological diseases, fibromyalgia, malignant tumors, or polymyalgia rheumatica.
• Presence of comorbidities that increase cardiovascular risk, such as hypertension, diabetes, or heart failure.
• Presence of more than one thromboembolism risk factor (obesity, history of thrombosis, prolonged immobilization, recent surgery, use of contraceptives, etc.).
• Presence of active skin lesions in the area where the sleeve will be placed, recent scars or burns, or chronic dermatological diseases that compromise skin integrity,
• 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: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low resistance exercise with blood occlusion; Eight sessions of exercise during 4 weeks, 30% repetition maximum, and 50% blood occlusion	Device: Resistance exercise with 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.
Active Comparator: Low resistance exercise without blood flow restriction; Eight sessions of exercise during 4 weeks, 30% repetition maximum, without blood occlusion	Procedure: Resistance exercise without 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 without 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 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.	Baseline, 2 weeks, and 4 weeks.

Secondary 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.	Baseline, 2 weeks, and 4 weeks.
Pressure pain threshold	Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer.	Before the session, immediately after, and 1 hour post-intervention
Kinesiophobia	Assessment of fear of movement or reinjury, assessed via the self-administered Tampa Scale of Kinesiophobia questionnaire.	Baseline, 2 weeks, and 4 weeks.
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.
Muscle Strength	Assessment of supraspinatus and internal and external rotator muscle strength, measured using a strap-secured handheld dynamometer.	Baseline, 2 weeks, and 4 weeks.
Pain Catastrophizing	Assessment of pain catastrophizing, measured using the self-report Pain Catastrophizing Scale (PCS), which evaluates exaggerated negative mental responses to actual or anticipated pain. The final score ranges from 0 to 52, with higher scores reflecting higher levels of catastrophizing.	Baseline, 2 weeks, and 4 weeks.
Pain and Disability	Assessment of pain and disability, measured using the self-report Shoulder Pain and Disability Index (SPADI). The score ranges from 0 to 100. A score of 0 indicates best, 100 indicates worst. A higher score shows more disabillity.	Baseline, 2 weeks, and 4 weeks.
Shoulder Disability	Assessment of shoulder disability, measured using the self-report Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH). The final score ranges from 0 (no disability) to 100 (severe/maximal disability), calculated from patient-rated difficulty on a 5-point scale for 30 items, with higher scores indicating greater impairment in arm, shoulder, and hand function.	Baseline, 2 weeks, and 4 weeks.
Satisfaction with methodology	Assessment of participant satisfaction with the methodology used, measured at the end of the program using a 5-point scale: very satisfied (5), satisfied (4), neutral (3), dissatisfied (2), very dissatisfied (1).	4 weeks.

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Adrián Escriche-Escuder, PhD, Universitat de València

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: January 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-3960959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• 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