Rotator Cuff Injury, Rotator Cuff Tear, Rotator Cuff Repair
Conditions
Keywords
blood flow restriction therapy, blood flow restriction training, exercise-induced hypoalgesia
Brief summary
The goal of this crossover randomized clinical trial is to compare the acute effect on exercise-induced hypoalgesia (EIH) between isometric exercise with blood flow restriction (BFR) and isometric exercise alone in adults undergoing arthroscopic rotator cuff repair. It is presumed that the addition of BFR to isometric exercises induces a greater effect in EIH. Patients who agree to participate in this research will be randomly assigned to two intervention sequences (AB or BA), where intervention A (experimental) corresponds to isometric exercises with BFR, and intervention B (control) corresponds to isometric exercises alone. For one week, each participant attended two sessions, separated by a 72-hours wash-out period. The primary variables will be the pressure pain threshold (PPT) and conditioned pain modulation (CPM). Secondary variables will be the pain intensity and distribution, kinesiophobia, upper extremity disability, and quality of life. Results will be measured before intervention (T1, pre-intervention), immediate after intervention (T2, post-intervention 1) and 10 minutes after intervention (T3, post-intervention 2).
Interventions
OTHERIsometric exercises
The three isometric exercises were performed without the addition of BFR following the best evidence recommendations. Each exercise was performed for 10 repetitions, with isometric contraction of 15 seconds followed by a rest period of 15 seconds, intensity with a load at 20-25% of the maximal voluntary isometric contraction (MVIC), rest period after each exercise of 2 minutes, and pain level below 5 on the verbal Numeric Pain Rating Scale (NPRS).
DEVICEIsometric exercises with BFR
Participants will perform three isometric exercises with BFR. 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. The 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 60% of the maximum occlusion pressure. Each exercise was performed for 10 repetitions, with isometric contraction of 15 seconds followed by a rest period of 15 seconds, intensity with a load at 20-25% of the MVIC, rest period after each exercise of 2 minutes with cuff deflated (reperfusion), and pain level below 5 on the NPRS.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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 RC tears, concomitant fracture, labral or nerve injury. * Suspicion of developing/diagnosis a frozen shoulder. * Revision surgery after RC repair. * Previous corticosteroid injection (\< 1 year). * Recent surgery (\< 1 year) in the contralateral shoulder. * A history of deep venous thrombosis/pulmonary embolism. * Peripheral vascular disease, thrombophilia or clotting disorders. * Severe or uncontrolled hypertension, or any comorbid condition that prevents participants from complete the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure pain threshold (PPT) | Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3) | Pressure pain threshold will be taken bilaterally on the deltoid muscle and the upper trapezius muscle using a Wagner FPX25 pressure algometer (kg/cm2/sec) |
| Condicionated pain modulation (CPM) | Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3) | Condicionated pain modulation will be measured with a conditioning stimulus of inmersion of the hand contralateral to the operated shoulder in cold water (10°C). The bilateral deltoid and trapezius muscles before and after the conditioning stimulus will be measured using a Wagner FPX25 pressure algometer (kg/cm2/sec) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity and distribution | Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3) | Visual Analogue Scale (0 to 10 centimeters) and pain distribution map (number of areas) |
| Kinesiophobia | Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3) | Tampa Scale of Kinesiophobia (11 to 44 points) |
| Self-reported upper extremity disability | Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3) | Shoulder Pain Disability Index (0 to 100%) |
| Self-reported quality of life | Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3) | Western Ontario Rotator Cuff Index (0 to 100%) |
Countries
Chile
Contacts
Primary ContactJose Casaña, PhD
Backup ContactFelipe Ponce-Fuentes, MSc
Outcome results
None listed