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

NCT04917952 | Unknown FDA Device

• 1 other identifier: 36676 - 27/04/202
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

chronic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of Dynamic weight-bearing Assessment of Pain (DAP) from baseline

  At baseline, Post 5 minutes, Post 24 hours

• Change of 30-second Chair Stand Test (30s-CST) from baseline

  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)

  At baseline, Post 5 minutes, Post 24 hours

Other Outcomes (4)

• Douleur Neuropathique 4 questionnaire (DN4 greek)

  At least 72 hours prior the intervention

• Knee Osteoarthritis Outcome Scale (KOOS greek)

  At least 72 hours prior the intervention

• 1 Repetition Maximum (1RM)

  At least 72 hours prior the intervention

Study Arms (2)

BFR group

EXPERIMENTAL

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

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.

Device: Sham Blood Flow Restriction (sham BFR)

Interventions

Blood Flow Restriction (BFR) DEVICE

* 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.

Also known as: Kaatsu

BFR group

Sham Blood Flow Restriction (sham BFR) DEVICE

* 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.

Also known as: Sham Kaatsu

Sham BFR group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of West Attica: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• George Gioftsos

  University of West Attica

  STUDY DIRECTOR

Central Study Contacts

Christos D. Anagnostis

CONTACT

+306909921606; mscphys18003@uniwa.gr

George Gioftsos

CONTACT

+302105387485; gioftsos@uniwa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 8, 2021
• Study Start: June 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share