Blood Flow Restriction Exercise-induced Hypoalgesia

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06924112
• Lead Sponsor: University of Valencia

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Study Start: 2025-05-01
• Primary Completion: 2025-08-29
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Kinesiophobia	Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)	Tampa Scale of Kinesiophobia (11 to 44 points)
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)
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%)

Trial Locations

Locations (1)

Clínica RedSalud Mayor; 🇨🇱 Temuco, Cautín, Chile