Effectiveness of Blood Flow Restriction Exercise Therapy to Reduce Pain in Knee Osteoarthritis Patients

Knee Osteoarthritis Clinical Trial

— BFR;OA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04917952
• Other study ID #: 36676 - 27/04/202
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: August 2021

Study information

• Verified date: June 2021
• Source: University of West Attica
• Contact: Christos D. Anagnostis
• Phone: +306909921606
• Email: mscphys18003[@]uniwa.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Blood Flow Restriction (BFR)
Exercise: Bilateral knee extension at range 90?-0? 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 90?-0?, 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 90?-0? 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)
Exercise: Bilateral knee extension at range 90?-0? 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 90?-0?, 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 90?-0? 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of West Attica

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Douleur Neuropathique 4 questionnaire (DN4 greek)	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	At least 72 hours prior the intervention
Other	Knee Osteoarthritis Outcome Scale (KOOS greek)	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	At least 72 hours prior the intervention
Other	1 Repetition Maximum (1RM)	1RM will be used diagnostically to identify the maximum strength of the participants. Each participant will extend their knees bilaterally, pain-free, 90o-0? with the maximum weight	At least 72 hours prior the intervention
Other	Other demographics and medical notes	Recording of demographics and medical notes will be used to identify the inclusion and exclusion criteria	At least 72 hours prior the intervention
Primary	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	At baseline, Post 5 minutes, Post 24 hours
Secondary	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)	At baseline, Post 5 minutes, Post 24 hours
Secondary	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	At baseline, Post 5 minutes, Post 24 hours
Secondary	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	At baseline, Post 5 minutes, Post 24 hours