Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair (S-TRONGER)

University of Valencia

Status: Not yet enrolling

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

Treatments: Device: Blood Flow Restriction Therapy; Other: Standard rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06788327

BFRT in RCR rehabilitation

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Standard exercises with BFRT

Experimental group

Description:

Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises with BFRT during the three phases of standard rehabilitation.

Treatment:

Other: Standard rehabilitation

Device: Blood Flow Restriction Therapy

Standard exercises alone

Active Comparator group

Description:

Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises without BFRT during the three phases of standard rehabilitation.

Treatment:

Other: Standard rehabilitation