Rotator Cuff Injury, Rotator Cuff Repair, Rotator Cuff Tears
Conditions
Keywords
blood flow restriction therapy, blood flow restriction training
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.
Interventions
OTHERStandard rehabilitation
Protocol based on the best available evidence and to be used in all participants in both groups. The standard exercises protocol will consist of three postoperative rehabilitation phases: phase I (weeks 1 to 4), phase II (weeks 5 to 8) and phase III (weeks 9 to 12). Sessions will be held 2 times a week for 12 weeks. Each session will last 45 minutes and will consist of six exercises in the phase I, eight exercises in phase II, and eight exercises in phase III.
DEVICEBlood Flow Restriction Therapy
Participants will perform three exercises of the standard exercises protocol with BFRT. An auto-regulated portable BFRT SmartCuffs® 3.0 Pro system with a 17-inch long and 5-inch-wide cuff (Smart Tools Plus, United States), placed on the most proximal part of the arm, will be used. Each BFRT session will begin with a maximal occlusion test to personalize the occlusion pressure to the participant. The limb occlusion pressure (LOP) will be set at 50% of the maximum occlusion pressure in the first stage and 60% in stages II and III. The participant will perform 75 repetitions per BFRT exercise divided into 4 sets (30, 15, 15, and 15 repetitions). The load intensity during the BFRT exercises will be set near to 3 out of 10 on the Borg's CR10 scale (weak), which corresponds to 30% of a 1RM effort. After each exercise, the cuff will be deflated, and the patient will rest for two minutes.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Opaque sealed envelopes
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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%) |
| Active Range of Motion | 0, 4 and 12 weeks | Shoulder flexion, abduction, and external rotation will be measured with a goniometer (degrees) |
Countries
Chile
Contacts
Primary ContactJosé Casaña, PhD
Backup ContactFelipe Ponce-Fuentes, MSc
Outcome results
None listed