Clinical trial NCT06924112: Blood Flow Restriction Exercise-induced Hypoalgesia
Official title: Exercise-induced Hypoalgesia Following Blood Flow Restriction in Rotator Cuff Repair Rehabilitation: a Randomized Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Injury
Rotator Cuff Tear
Rotator Cuff Repair
Keywords: blood flow restriction therapy
blood flow restriction training
exercise-induced hypoalgesia
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Pressure pain threshold (PPT)
timeFrame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
measure: Condicionated pain modulation (CPM)
timeFrame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Secondary outcomes:
measure: Pain intensity and distribution
timeFrame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
measure: Kinesiophobia
timeFrame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
measure: Self-reported upper extremity disability
timeFrame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
measure: Self-reported quality of life
timeFrame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Clínica RedSalud Mayor
state: Cautín
Study officials:
affiliation: Universidad Mayor
name: Felipe Ponce-Fuentes, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Jose Casaña, PhD
role: STUDY_DIRECTOR
affiliation: University of Valencia
name: Joaquin Calatayud, PhD
role: STUDY_DIRECTOR
affiliation: Universiteit Antwerpen
name: Filip Struyf, PhD
role: STUDY_DIRECTOR
References:
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