Blood Flow Restriction Exercise-induced Hypoalgesia

N/ANot Yet RecruitingNCT06924112

University of Valencia22 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rotator Cuff Injury Rotator Cuff Tear

Interventions

Isometric exercisesOTHER

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).

Isometric exercises with BFRDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pressure pain threshold (PPT)

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)