Blood Flow Restriction Exercise-induced Hypoalgesia

University of Valencia

Status: Not yet enrolling

Conditions: Rotator Cuff Tear; Rotator Cuff Injury; Rotator Cuff Repair

Treatments: Device: Isometric exercises with BFR; Other: Isometric exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06924112

P-5.2025

Details and patient eligibility

About

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).

Enrollment: 22 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Isometric exercises with BFR (Intervention A)

Experimental group

Description:

Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises with BFR

Treatment:

Other: Isometric exercises

Device: Isometric exercises with BFR

Isometric exercises alone (Intervention B)

Active Comparator group

Description:

Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises without BFR

Treatment:

Other: Isometric exercises