Blood Flow Restriction Exercise-induced Hypoalgesia

ConditionsRotator Cuff Injury Rotator Cuff Tear Rotator Cuff Repair

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-65

SponsorUniversity of Valencia

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

Isometric exercises
Other intervention
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 BFR
Device
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.

Treatment groups

22 Participants

are divided into 2 treatment groups

Group A: Isometric exercises with BFR (Intervention A)Experimental treatment 2 interventions

Group B: Isometric exercises alone (Intervention B)Active comparator 1 intervention

Trial 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)

Time frame