BFR;OA: Effectiveness of Blood Flow Restriction Exercise Therapy to Reduce Pain in Knee Osteoarthritis Patients

Sponsor

University of West Attica (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04917952

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Device: Blood Flow Restriction (BFR) Device: Sham Blood Flow Restriction (sham BFR)	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Blood Flow Restriction (BFR) Exercise Therapy to Reduce Pain in Knee Osteoarthritis (OA) Patients. A Double-blinded Randomised Clinical Trial

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BFR group The intervention group will receive resisted knee extension 30% of 1RM with blood flow restriction.	Device: Blood Flow Restriction (BFR) 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. Other Names: Kaatsu
Placebo Comparator: Sham BFR group The control group will receive resisted knee extension 30% of 1RM with sham blood flow restriction.	Device: Sham Blood Flow Restriction (sham BFR) 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. Other Names: Sham Kaatsu

Arm

Intervention/Treatment

Experimental: BFR group

The intervention group will receive resisted knee extension 30% of 1RM with blood flow restriction.

Device: Blood Flow Restriction (BFR)

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.

Other Names:

Kaatsu

Placebo Comparator: Sham BFR group

The control group will receive resisted knee extension 30% of 1RM with sham blood flow restriction.

Device: Sham Blood Flow Restriction (sham BFR)

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.

Other Names:

Sham Kaatsu

Outcome Measures

Primary Outcome Measures

Change of Pain Pressure Threshold (PPT) from baseline [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

Secondary Outcome Measures

Change of Dynamic weight-bearing Assessment of Pain (DAP) from baseline [At baseline, Post 5 minutes, Post 24 hours]
DAP is correlating VAS/NRS pain reporting scales with the functional test of 30-second Chair Stand Test (30s-CST)
Change of 30-second Chair Stand Test (30s-CST) from baseline [At baseline, Post 5 minutes, Post 24 hours]
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
Change of pain score from baseline with the use of reporting scales Visual Analogue Scale (VAS) / Numeric Rating Scale (NRS) [At baseline, Post 5 minutes, Post 24 hours]
Pain reporting scales as NRS are using 0-10 grades to measure how big the pain is, 10 is for the worst pain

Other Outcome Measures

Douleur Neuropathique 4 questionnaire (DN4 greek) [At least 72 hours prior the intervention]
Greek version of DN4 will be used diagnostically to identify the existence of neuropathic pain, a score greater than 4/10 suggests the existence of neuropathic pain
Knee Osteoarthritis Outcome Scale (KOOS greek) [At least 72 hours prior the intervention]
Greek version of the KOOS will be used diagnostically to identify the severity of the disease. Each category score ranges 0-100, the minimum score is the worst
1 Repetition Maximum (1RM) [At least 72 hours prior the intervention]
1RM will be used diagnostically to identify the maximum strength of the participants. Each participant will extend their knees bilaterally, pain-free, 90o-0ο with the maximum weight
Other demographics and medical notes [At least 72 hours prior the intervention]
Recording of demographics and medical notes will be used to identify the inclusion and exclusion criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.)
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of West Attica

Investigators

Study Director: George Gioftsos, University of West Attica

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christos Anagnostis, Principal Investigator, University of West Attica

ClinicalTrials.gov Identifier:

NCT04917952

Other Study ID Numbers:

36676 - 27/04/202

First Posted:

Jun 8, 2021

Last Update Posted:

Jun 8, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Christos Anagnostis, Principal Investigator, University of West Attica

chronic pain

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Jun 8, 2021