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Clinical Trials/NCT07300384
NCT07300384
Not yet recruiting
Not Applicable

Acute Effects of Blood Flow Restriction Training to Failure on Hypoalgesia in Patients With Severe Knee Osteoarthritis Using Dynamic or Fixed Occlusion Pressure

University of Valencia1 site in 1 country45 target enrollmentStarted: January 1, 2026Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
45
Locations
1
Primary Endpoint
Pain intensity at rest (Visual Analogue Scale, 0-10)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study aims to compare the acute effects on hypoalgesia of training to failure using blood flow restriction (BFR) with dynamic occlusion versus BFR with fixed occlusion in patients with severe gonarthrosis. Two different training conditions will be performed with varying levels of blood flow occlusion (%BFR) and percentage of load (%RM): 1) 30% RM and 50% BFR with dynamic pressure; 2) 30% RM and 50% BFR with fixed pressure. Each participant will complete two individual sessions under different training conditions, randomly assigned with a 72-hour interval between sessions.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age between 50 and 85 years
  • •Diagnosis of severe gonarthrosis according to the clinical and radiographic criteria of the American College of Rheumatology guidelines.
  • •On the waiting list for unilateral total knee replacement (TKR) surgery

Exclusion Criteria

  • •Pain in the contralateral leg with an intensity ≥80/100 mm on the visual analog scale (VAS) during daily activities.
  • •Previous hip or knee replacement surgery and osteotomy within the last year.
  • •Autoimmune arthritis
  • •Medical conditions that contraindicate exercise.
  • •Participation in exercise programs (\>2 days/week with training at intensities of 10-15 1RM) in the previous six months.
  • •History of stroke, brain surgery, major depression, or self-reported cognitive impairment that could affect performance in the study.
  • •Cardiovascular, thrombotic, or vascular risk factors (uncontrolled hypertension, peripheral arterial disease, history of deep vein thrombosis or pulmonary embolism, heart failure, severe varicose veins, or uncontrolled anticoagulant therapy).
  • •Skin or local alterations at the cuff application site (ulcers, open wounds, infections, lymphedema, or severe edema).
  • •Inability to communicate normally or with impaired communication skills.

Outcomes

Primary Outcomes

Pain intensity at rest (Visual Analogue Scale, 0-10)

Time Frame: Periprocedural

Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.

Secondary Outcomes

  • Perceived exertion scale (The BORG CR10 Scale)(Periprocedural)
  • Kinesiophobia (The Tampa Scale for Kinesiophobia)(Before the intervention and at the end of the study)
  • Pressure pain threshold(Periprocedural)
  • Occurrence of adverse effects(Immediately after the intervention, 72 hours later, and two weeks after the study ended)
  • Pain catastrophizing(Before the intervention and at the end of the study)
  • Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index)(Before the intervention and at the end of the study)
  • Number of Repetitions Performed(Periprocedural)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adrián Escriche Escuder

Assistant professor

University of Valencia

Study Sites (1)

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