Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair

Not Applicable

Not yet recruiting

• Conditions: Rotator Cuff Injury; Rotator Cuff Tears; Rotator Cuff Repair

• Registration Number: NCT06788327
• Lead Sponsor: University of Valencia

Brief Summary

The goal of this clinical trial is to determine the effectiveness of postoperative standard exercises with blood flow restriction therapy (BFRT) versus standard exercises alone on shoulder muscle strength and mass in participants with surgically treated rotator cuff tear. It is presumed that the addition of BFRT will significantly improve the shoulder strength and muscle mass at the end of the intervention period compared to the group receiving only standard exercises.

Patients who agree to participate in this research will be randomly assigned to a control group (standard exercises alone) or an experimental group (standard rehabilitation with BFRT). The duration of the postoperative intervention will be 12 weeks. The primary variables will be the shoulder muscle strength and muscle mass. Secondary variables will be the active shoulder mobility, pain intensity, upper limb disability, and health-related quality of life. Results will be measured at 0, 4 and 12 weeks postoperative.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Study Start: 2025-03-03
• Primary Completion: 2026-12-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age between 40-65 years
• Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging
• Undergoing arthroscopic rotator cuff repair
• Be able to read and understand Spanish

Exclusion Criteria

• Massive irreparable rotator cuff tear
• Concomitant fracture
• Labral or nerve injury
• Suspicious of developing a frozen shoulder
• Revision surgery after rotator cuff repair
• Previous corticosteroid injection (< 6 months)
• Recent surgery (< 1 year) in the contralateral shoulder
• History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia or clotting disorders
• Severe or uncontrolled hypertension, or any comorbid condition that impedes participants to complete the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder muscle strength	0, 4 and 12 weeks	Shoulder abduction and external rotation maximum voluntary isometric strength will be measured using dynamometry (kilograms)
Shoulder muscle mass	0, 4 and 12 weeks	Supraspinatus and long head biceps brachii tendon thickness will be measured using ultrasound imaging (milimeters)

Secondary Outcome Measures

Name	Time	Method
Active Range of Motion	0, 4 and 12 weeks	Shoulder flexion, abduction, and external rotation will be measured with a goniometer (degrees)
Pain intensity	0, 4 and 12 weeks	Visual Analogue Scale (0 to 10 centimeters)
Self-reported upper limb disability	0, 4 and 12 weeks	Shoulder Pain Disability Index (0 to 100%)
Self-reported quality of life	0, 4 and 12 weeks	Western Ontario Rotator Cuff Index (0 to 100%)

Trial Locations

Locations (1)

Clínica RedSalud Mayor; 🇨🇱 Temuco, Cautín, Chile