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NCT Number: NCT07300384

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

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.

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Key information

Conditions

Severe Knee Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physiotherapy, University of Valencia, Valencia, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure.

Device

A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with dynamic occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.

Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure.

Device

A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with fixed occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.

Primary outcomes

  1. 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

  1. Pressure pain threshold

    Time frame: Periprocedural

    Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer

  2. Perceived exertion scale (The BORG CR10 Scale)

    Time frame: Periprocedural

    The BORG CR10 Scale is a subjective tool used to measure the intensity of the perceived exertion of a person during an activity through a rate of perceived exertion (RPE). It is scored on a scale of 0 to 10, where 0 is no exertion and 10 is maximum exertion.

  3. Occurrence of adverse effects

    Time frame: Immediately after the intervention, 72 hours later, and two weeks after the study ended

    Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report.

  4. Kinesiophobia (The Tampa Scale for Kinesiophobia)

    Time frame: Before the intervention and at the end of the study

    The Tampa Scale for Kinesiophobia is a questionnaire designed to assess fear of movement and avoidance of physical activity due to pain. It consists of 17 items answered on a scale of 1 (strongly disagree) to 4 (strongly agree), measuring two main factors: fear of movement and activity avoidance. The total score ranges from 17 to 68 points, with higher scores indicating greater kinesophobia.

  5. Pain catastrophizing

    Time frame: Before the intervention and at the end of the study

    The Pain Catastrophizing Scale includes 13 items in total (0-52 points) that describe different thoughts and feelings associated with pain. The PCS consists of 5 grades: 0 not at all, 1 a little, 2 moderately, 3 a lot, and 4 always. The participant must mark their situation for each case. Higher scores correspond to higher levels of pain catastrophizing

  6. Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index)

    Time frame: Before the intervention and at the end of the study

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a questionnaire designed to assess pain, stiffness, and function in patients with knee and hip osteoarthritis. It consists of 24 items, divided into three subscales that assess pain (5 items), stiffness (2 items), and physical function (17 items). Responses are given on a 0-to-4 Likert-type scale, where higher scores indicate greater impairment.

  7. Number of Repetitions Performed

    Time frame: Periprocedural

    The number of maximum repetitions performed in each set will be assessed for each patient

Study contacts

Contact information is provided by the study sponsor or research team.

Adrián Escriche-Escuder, PhD

CONTACT

[email protected]

+34 963 98 38 55

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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