Blood Flow Restriction Therapy for Lower Limb Injury

Overseen By Michael Moore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Impaired circulation, Severe hypertension, Cancer, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

128 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Blood Flow Restriction Therapy for lower limb injury?

Research shows that Blood Flow Restriction Therapy (BFR) can improve strength, endurance, and function while reducing pain in various musculoskeletal injuries. It has been effective in knee osteoarthritis and knee injuries, suggesting potential benefits for lower limb injuries as well. ^{1 2 3 4 5}

Is Blood Flow Restriction Therapy generally safe for humans?

Blood Flow Restriction Therapy is generally considered safe, with most side effects being minor, such as bruising, lightheadedness, and cramping. In a survey of healthcare professionals, 89% believed it was safe for people with neurologic conditions, and no side effects requiring medical attention were reported. ^{1 2 6 7 8}

How is Blood Flow Restriction Therapy different from other treatments for lower limb injury?

Blood Flow Restriction Therapy is unique because it allows for muscle strengthening with low-weight exercises by partially restricting blood flow using an inflatable cuff, reducing stress on tissues and joints compared to traditional high-load exercises. ^{1 9 10 11 12}

What is the purpose of this trial?

The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.

Research Team

Guillem Gonzales-Lomas, MD

Principal Investigator

NYU Langone

Eligibility Criteria

This trial is for adults aged 18-65 with lower limb extensor injuries who plan to undergo physical therapy. It's not suitable for those under 18 or over 65, mentally impaired individuals, people using mobility aids before injury, patients with prior similar injuries, circulation issues, severe hypertension, additional leg trauma, sickle cell anemia, venous thromboembolism or cancer.

Inclusion Criteria

I have an injury to my lower limb's extensor (like a torn quadriceps or patella tendon, or a broken kneecap).

ASA class I-II

I plan to undergo physical therapy as part of my treatment.

Exclusion Criteria

Any patient considered a vulnerable subject

I am legally competent and mentally sound.

I plan to receive the standard treatment, not the study therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo blood flow restriction therapy with a pressure cuff to enhance muscle hypertrophy and rehabilitation

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Blood Flow Restriction Therapy

Trial Overview The study tests the effectiveness of blood flow restriction therapy in treating lower limb extensor injuries. Participants will receive physical therapy either with a pressure cuff that restricts blood flow or a placebo cuff without this effect to compare results on muscle strength and mass.

Participant Groups

Group I: blood flow restriction therapy (pressure cuff) Experimental Treatment 1 Intervention

The cuff will be placed around the upper thigh of the injured leg and set at a pressure that will prevent approximately 80% arterial blood flow. The machine will determine what pressure is required to reach that 80%, when placed on the leg and turned on.

Group II: blood flow restriction therapy (placebo) Placebo Group 1 Intervention

Patients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm

Blood Flow Restriction Therapy is already approved in United States, Japan, European Union for the following indications:

Approved in United States as Blood Flow Restriction Therapy for:

• Musculoskeletal injuries
• Pre-surgical strengthening
• Post-surgical rehabilitation
• Arthritis
• Tendinitis
• Non-union fractures
• IT band issues

Approved in Japan as KAATSU Training for:

• Muscle hypertrophy
• Muscle strengthening
• Rehabilitation after injury or surgery

Approved in European Union as Blood Flow Restriction Therapy for:

• Orthopedic rehabilitation
• Muscle strengthening
• Pain relief

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

A survey of 250 orthopedic surgeons revealed that 59.8% currently use blood flow restriction (BFR) therapy, primarily for rehabilitation after anterior cruciate ligament reconstruction (ACLR), indicating its growing acceptance in clinical practice.

BFR therapy is typically applied 2-3 times per week, allowing patients to achieve benefits similar to high-intensity training while using lighter weights, which can be particularly useful for those recovering from musculoskeletal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. Castle, JP., Tramer, JS., Turner, EHG., et al.[2023]

Blood flow restriction training (BFRT) does not show significantly greater efficacy than conventional resistance training for treating knee osteoarthritis, based on a meta-analysis of 5 studies with low to moderate risk of bias.

BFRT may have a lower incidence of adverse events compared to high-load resistance training, suggesting it could be a safer option for patients with knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Wang, HN., Chen, Y., Cheng, L., et al.[2022]

This clinical trial will evaluate the effectiveness of different levels of blood flow restriction (BFR) combined with low load or rest in reducing pain for 165 patients aged 50 and older with knee osteoarthritis, comparing these methods to high-intensity resistance exercise.

The study aims to determine if BFR training can provide similar pain relief as high-intensity workouts while causing less immediate discomfort, potentially leading to better adherence to exercise regimens for patients with knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial. Jardim, RAC., de Sousa, TS., Dos Santos, WNN., et al.[2022]

Low-load resistance training with blood flow restriction (L-BFR) significantly increased muscle strength in patients with knee injuries, showing a standardized mean difference of 0.83, indicating its effectiveness in rehabilitation.

L-BFR also led to a significant reduction in pain scores compared to high-load and low-load resistance training, suggesting it may be a beneficial intervention for managing pain during knee rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Blood Flow Restriction Training on Muscle Strength and Pain in Patients With Knee Injuries: A Meta-Analysis. Li, S., Shaharudin, S., Abdul Kadir, MR.[2023]

In a study of 48 patients who underwent total knee arthroplasty (TKA), blood flow restriction (BFR) therapy did not lead to significant improvements in quadriceps and hamstring strength compared to standard physical therapy (PT) alone after a 6-week program.

Both groups, regardless of BFR use, showed a high preference for avoiding revision TKA, with over 80% of patients opting not to undergo further surgery after completing their rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Blood Flow Restriction Therapy Improve Leg Strength in Patients With a Painful Total Knee Arthroplasty? Majors, IB., Mears, SC., Oholendt, CK., et al.[2023]

A survey of 108 participants using BFR/KAATSU devices revealed that 61.4% used inflatable devices, and most had received some form of education before using the equipment, indicating a commitment to safe application of the training method.

Adverse effects such as bruising, lightheadedness, and cramping were reported by 21.4% of users, highlighting the need for careful monitoring and screening before administering BFR/KAATSU training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Trends in Blood Flow Restriction. Cuffe, M., Novak, J., Saithna, A., et al.[2022]

A survey of 112 healthcare professionals revealed that 89% believe blood flow restriction (BFR) training is safe for individuals with neurologic conditions, indicating a positive perception of its safety despite limited evidence.

While 38% of respondents reported using BFR, primarily with resistance training to improve strength, the most common side effect was intolerance to pressure, with no serious medical issues reported, highlighting the need for further research to validate its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of blood flow restriction in people with neurologic conditions: a cross-sectional survey. Mañago, MM., Kimbrell, K., Hager, ER., et al.[2022]

Resistance training with blood flow restriction (BFR) at low loads can produce muscle fatigue comparable to high-load training, with 21 participants showing that 20% maximal voluntary contraction (MVC) with continuous partial occlusion caused greater fatigue than high-load training (31% vs 19% decrement in MVC).

The study suggests that specific BFR protocols, particularly the 20% MVC with continuous partial occlusion, may be more effective for muscle fatigue than other BFR methods or high-load training, indicating potential for optimizing resistance training strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise load and blood-flow restriction on skeletal muscle function. Cook, SB., Clark, BC., Ploutz-Snyder, LL.[2022]

A randomized controlled trial with 26 healthy participants showed that low-load blood flow restriction (BFR) training significantly increased muscle strength and limb circumference compared to a control group, with no reported adverse events.

BFR training was effective for strengthening muscle groups both proximal and distal to the tourniquet, and even improved strength in the non-restricted extremity, suggesting a systemic benefit from this training method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Bowman, EN., Elshaar, R., Milligan, H., et al.[2020]

Blood flow restriction (BFR) training is effective for increasing muscle size and strength, making it a promising option for treating musculoskeletal issues and aiding in postoperative recovery.

The article highlights the need for more research on BFR's applications in rehabilitation, while also sharing the authors' practical experiences with its use after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. Wilkinson, BG., Donnenwerth, JJ., Peterson, AR.[2019]

Blood flow restriction (BFR) training at low loads (20% of 1RM) is effective in improving muscle strength in patients with chronic quadriceps and hamstring weakness, as demonstrated in a case series of seven patients with traumatic lower extremity injuries.

After 2 weeks of BFR therapy, all patients showed significant improvements in muscle strength metrics, with peak torque increasing by 13% to 37% and average power improving by 42% to 81%, indicating that BFR can be a valuable treatment for those who struggle with traditional rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction rehabilitation for extremity weakness: a case series. Hylden, C., Burns, T., Stinner, D., et al.[2022]

In a study of 39 female patients with chronic ankle instability, Blood Flow Restriction (BFR) training alone did not improve muscle strength, dynamic balance, or physical function, while combined BFR with rehabilitation and rehabilitation alone showed significant improvements.

Both the BFR+R and R groups demonstrated enhanced muscle strength and dynamic balance, indicating that BFR is more effective when used alongside rehabilitation rather than as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of blood flow restriction as a stand-alone treatment on muscle strength, dynamic balance, and physical function in female patients with chronic ankle instability. Mahmoud, WS., Radwan, NL., Ibrahim, MM., et al.[2023]

References

1. India pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Blood Flow Restriction Training on Muscle Strength and Pain in Patients With Knee Injuries: A Meta-Analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Does Blood Flow Restriction Therapy Improve Leg Strength in Patients With a Painful Total Knee Arthroplasty? [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Current Trends in Blood Flow Restriction. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

Clinical use of blood flow restriction in people with neurologic conditions: a cross-sectional survey. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise load and blood-flow restriction on skeletal muscle function. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Blood flow restriction rehabilitation for extremity weakness: a case series. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Effect of blood flow restriction as a stand-alone treatment on muscle strength, dynamic balance, and physical function in female patients with chronic ankle instability. [2023]