Knee OsteoarthritisBFR;OANCT04917952
Effectiveness of Blood Flow Restriction Exercise Therapy to Reduce Pain in Knee Osteoarthritis Patients
A study testing Blood Flow Restriction (BFR) in people with Knee Osteoarthritis, run by University of West Attica.
Trial summary
Resistance training of knee extensor muscles is being used in physiotherapy management in knee osteoarthritis (OA) to improve pain and physical function. Blood flow restriction (BFR) has been suggested to improve pain and increase muscle strength in healthy subjects and certain diseases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Blood Flow Restriction (BFR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current osteoarthritis clinical diagnosis according to either European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) criteria
- VAS/NRS Knee pain ≥3/10 during activity
Who cannot join
- Previous experience with BFR
- Has followed knee exercise or kinesiotherapy program in the past 3 months
- New medicines in the past 3 months
- Any lower limb surgery in the past 6 months
- Knee arthroplasty surgery (Knee replacement)
- Any active healing process affecting walking (fracture, sprain, strain, etc.)
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- Diagnosed with rheumatologic/neurologic disease affecting functionality
- Diagnosed or history of heart or vascular diseases
- Diagnosed with respiratory/metabolic disease
- Personal history of cancer
- Cognitive problems
- Pregnancy (only for female participants)
- Any other indication not to participate in exercise
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Blood Flow Restriction (BFR) Exercise Therapy to Reduce Pain in Knee Osteoarthritis (OA) Patients. A Double-blinded Randomised Clinical Trial
Resistance training of knee extensor muscles is being used in physiotherapy management in knee osteoarthritis (OA) to improve pain and physical function. Blood flow restriction (BFR) has been suggested to improve pain and increase muscle strength in healthy subjects and certain diseases. Although there are clinical studies suggesting improvements in knee osteoarthritis symptoms after 4-12 weeks of exercise with BFR, the acute effects of the intervention have not been known.
This study aims to assess the effectiveness of low load exercise therapy combined with BFR on acute pain reduction and within 24 hours post-intervention on people with knee OA compared to a placebo group.
This study will take place in Athens, Greece, as part of the postgraduate MSc program of the Physiotherapy department of the University of West Attica.
Read the detailed description
A double-blinded randomised clinical trial with a total of 42 participants will be randomly assigned to the intervention (n=21) or the control group (n=21).
The intervention group will complete a single exercise session with BFR 80%, 30% 1RM, while the control group will have sham BFR, 30% 1RM.
Pain Pressure Threshold (PPT) will be assessed with the use of a digital pressure dynamometer.
- Conditions
- Knee Osteoarthritis
- Being tested
- Blood Flow Restriction (BFR), Sham Blood Flow Restriction (sham BFR)
- Keywords
- chronic pain
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction (BFR)Device
Also called Kaatsu
- Exercise: Bilateral knee extension at range 90ο-0ο
- Load: 30% 1RM
- BFR: Yes, 80% at both legs
- Sets: 4
- Reps: 30-15-15-15
- Rest: 30'' between sets
- Tempo: 2-0-2-0
Participants of the intervention group will receive an exercise protocol with blood flow restriction once and will be measured for changes in PPT by the use of a digital dynamometer.
Exercise protocol will be four sets of bilateral knee extension 90ο-0ο, reps per set 30-15-15-15, tempo 2-0-2-0 and rest 30 sec between sets.
In order to determine the training load 30% of 1RM, participants will perform bilateral knee extension in range 90ο-0ο with pain-free maximum resistance. The derived 1RM will be used to determine the 30% 1RM load.
Blood flow restriction will be applied at 80% by using pressure cuffs. The cuffs will be applied to the proximal thigh. Cuff pressure needed for a 100% vascular occlusion will be determined for each individual at a seated and relaxed position.
Sham Blood Flow Restriction (sham BFR)Device
Also called Sham Kaatsu
- Exercise: Bilateral knee extension at range 90ο-0ο
- Load: 30% 1RM
- BFR: Yes, Sham BFR, 10mm Hg at both legs
- Sets: 4
- Reps: 30-15-15-15
- Rest: 30'' between sets
- Tempo: 2-0-2-0
Participants of the control group will receive an exercise protocol with sham blood flow restriction once and will be measured for changes in PPT by the use of a digital dynamometer.
Exercise protocol will be four sets of bilateral knee extension 90ο-0ο, reps per set 30-15-15-15, tempo 2-0-2-0 and rest 30 sec between sets.
In order to determine the training load 30% of 1RM, participants will perform bilateral knee extension in range 90ο-0ο with pain-free maximum resistance. The derived 1RM will be used to determine the 30% 1RM load.
Sham technique for blood flow restriction will be applied by using pressure cuffs inflated at 10mm Hg. The cuffs will be applied to the proximal thigh. Cuff pressure will be applied for each individual at a seated and relaxed position.
| Study group | Role | What they receive |
|---|---|---|
| BFR group | Experimental | The intervention group will receive resisted knee extension 30% of 1RM with blood flow restriction. Receives: Device: Blood Flow Restriction (BFR) |
| Sham BFR group | Placebo comparator | The control group will receive resisted knee extension 30% of 1RM with sham blood flow restriction. Receives: Device: Sham Blood Flow Restriction (sham BFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain Pressure Threshold (PPT) from baseline
Pain will be measured with a digital dynamometer. Raise of the PPT value means a better outcome
Measured: At baseline, Post 5 minutes, Post 24 hours
Secondary outcomes (3)
Change of Dynamic weight-bearing Assessment of Pain (DAP) from baseline
DAP is correlating VAS/NRS pain reporting scales with the functional test of 30-second Chair Stand Test (30s-CST)
Measured: At baseline, Post 5 minutes, Post 24 hours
Change of 30-second Chair Stand Test (30s-CST) from baseline
30s-CST is a functional assessment evaluating leg strength and dynamic balance, the more repetitions one can do during the 30'', the better the outcome
Measured: At baseline, Post 5 minutes, Post 24 hours
Change of pain score from baseline with the use of reporting scales Visual Analogue Scale (VAS) / Numeric Rating Scale (NRS)
Pain reporting scales as NRS are using 0-10 grades to measure how big the pain is, 10 is for the worst pain
Measured: At baseline, Post 5 minutes, Post 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Anagnostis, University of West Attica
- Investigators
- George Gioftsos, Study director, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917952
- Sponsor's protocol ID
- 36676 - 27/04/202
- Acronym
- BFR;OA
- Status last verified
- Jun 2021
- First submitted
- 25 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Blood Flow Restriction (BFR) Exercise Therapy to Reduce Pain in Knee Osteoarthritis (OA) Patients. A Double-blinded Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04917952
- Acronym / sponsor ID
- BFR;OA / 36676 - 27/04/202
- Conditions
- Knee Osteoarthritis
- Keywords
- chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Resistance training of knee extensor muscles is being used in physiotherapy management in knee osteoarthritis (OA) to improve pain and physical function. Blood flow restriction (BFR) has been suggested to improve pain and increase muscle strength in healthy subjects and certain diseases. Although there are clinical studies suggesting improvements in knee osteoarthritis symptoms after 4-12 weeks of exercise with BFR, the acute effects of the intervention have not been known.
This study aims to assess the effectiveness of low load exercise therapy combined with BFR on acute pain reduction and within 24 hours post-intervention on people with knee OA compared to a placebo group.
This study will take place in Athens, Greece, as part of the postgraduate MSc program of the Physiotherapy department of the University of West Attica.
Detailed description
A double-blinded randomised clinical trial with a total of 42 participants will be randomly assigned to the intervention (n=21) or the control group (n=21).
The intervention group will complete a single exercise session with BFR 80%, 30% 1RM, while the control group will have sham BFR, 30% 1RM.
Pain Pressure Threshold (PPT) will be assessed with the use of a digital pressure dynamometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR group | Experimental | Device: Blood Flow Restriction (BFR)The intervention group will receive resisted knee extension 30% of 1RM with blood flow restriction. |
| Sham BFR group | Placebo comparator | Device: Sham Blood Flow Restriction (sham BFR)The control group will receive resisted knee extension 30% of 1RM with sham blood flow restriction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Current osteoarthritis clinical diagnosis according to either European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) criteria
- VAS/NRS Knee pain ≥3/10 during activity
Key exclusion criteria (13 listed)
- Previous experience with BFR
- Has followed knee exercise or kinesiotherapy program in the past 3 months
- New medicines in the past 3 months
- Any lower limb surgery in the past 6 months
- Knee arthroplasty surgery (Knee replacement)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction (BFR)Also: Kaatsu* Exercise: Bilateral knee extension at range 90ο-0ο * Load: 30% 1RM * BFR: Yes, 80% at both legs * Sets: 4 * Reps: 30-15-15-15 * Rest: 30'' between sets * Tempo: 2-0-2-0 Participants of the intervention group will receive an exercise protocol with blood flow restriction once and will be measured for changes in PPT by the use of a digital dynamometer. Exercise protocol will be four sets of bilateral knee extension 90ο-0ο, reps per set 30-15-15-15, tempo 2-0-2-0 and rest 30 sec between sets. In order to determine the training load 30% of 1RM, participants will perform bilateral knee extension in range 90ο-0ο with pain-free maximum resistance. The derived 1RM will be used to determine the 30% 1RM load. Blood flow restriction will be applied at 80% by using pressure cuffs. The cuffs will be applied to the proximal thigh. Cuff pressure needed for a 100% vascular occlusion will be determined for each individual at a seated and relaxed position. | Device | BFR group |
| Sham Blood Flow Restriction (sham BFR)Also: Sham Kaatsu* Exercise: Bilateral knee extension at range 90ο-0ο * Load: 30% 1RM * BFR: Yes, Sham BFR, 10mm Hg at both legs * Sets: 4 * Reps: 30-15-15-15 * Rest: 30'' between sets * Tempo: 2-0-2-0 Participants of the control group will receive an exercise protocol with sham blood flow restriction once and will be measured for changes in PPT by the use of a digital dynamometer. Exercise protocol will be four sets of bilateral knee extension 90ο-0ο, reps per set 30-15-15-15, tempo 2-0-2-0 and rest 30 sec between sets. In order to determine the training load 30% of 1RM, participants will perform bilateral knee extension in range 90ο-0ο with pain-free maximum resistance. The derived 1RM will be used to determine the 30% 1RM load. Sham technique for blood flow restriction will be applied by using pressure cuffs inflated at 10mm Hg. The cuffs will be applied to the proximal thigh. Cuff pressure will be applied for each individual at a seated and relaxed position. | Device | Sham BFR group |
Primary outcome
Change of Pain Pressure Threshold (PPT) from baseline
Time frame: At baseline, Post 5 minutes, Post 24 hours
Pain will be measured with a digital dynamometer. Raise of the PPT value means a better outcome
3 secondary outcomes
Change of Dynamic weight-bearing Assessment of Pain (DAP) from baseline
Time frame: At baseline, Post 5 minutes, Post 24 hours
Change of 30-second Chair Stand Test (30s-CST) from baseline
Time frame: At baseline, Post 5 minutes, Post 24 hours
Change of pain score from baseline with the use of reporting scales Visual Analogue Scale (VAS) / Numeric Rating Scale (NRS)
Time frame: At baseline, Post 5 minutes, Post 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Gioftsos study director
University of West Attica
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction (BFR) in people with Knee Osteoarthritis, run by University of West Attica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christos D. Anagnostis (+306909921606, mscphys18003@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain Pressure Threshold (PPT) from baseline (time frame: At baseline, Post 5 minutes, Post 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.