Blood Flow Restriction Therapy for Achilles Tendon Injury

Overseen By Larry Chen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Impaired circulation, Hypertension, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

57 Participants Needed

Trial Summary

What is the purpose of this trial?

Blood flow restriction (BFR) therapy is a brief and partial restriction of venous outflow of an extremity during low load resistance exercises. It is a safe and effective method of improving strength in healthy and active individuals, recovering from orthopedic pathologies and procedures. This prospective, randomized study will look at the implications this form of treatment has on the rehabilitation of Achilles injuries.

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 Achilles Tendon Injury?

Research shows that blood flow restriction therapy (BFRT) can help improve strength, endurance, and function, and reduce pain in various musculoskeletal injuries, which suggests it may be beneficial for Achilles tendon injuries as well. ^{1 2 3 4 5}

Is Blood Flow Restriction Therapy generally safe for humans?

Blood Flow Restriction Therapy (BFRT) can be safe for healthy individuals, but it may cause increased blood pressure and other cardiovascular issues. People with conditions like heart disease, high blood pressure, or diabetes should be cautious and consult a doctor before trying BFRT. ^{1 5 6 7 8}

How does blood flow restriction therapy differ from other treatments for Achilles tendon injury?

Blood flow restriction therapy is unique because it involves exercising with a cuff that restricts blood flow to the muscles, which can stimulate tendon healing and strength with lower intensity exercises compared to traditional high-intensity workouts. This method may lead to a positive response in Achilles tendon thickness, making it a novel approach for tendon rehabilitation. ^{1 3 5 7 9}

Research Team

Guillem Gonzalez-Lomas, MD

Principal Investigator

New York Langone Health

Eligibility Criteria

This trial is for adults aged 18-65 with an Achilles tendon injury who plan to undergo standard physical therapy. It's not suitable for those under 18 or over 65, individuals with mental impairments, patients not opting for the study therapy, vulnerable subjects, or anyone with poor blood circulation or severe high blood pressure.

Inclusion Criteria

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

I have been diagnosed with an Achilles injury.

I am between 18 and 65 years old.

Exclusion Criteria

I have poor blood flow in my limbs, had surgery to improve this, or have severe high blood pressure.

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

I am either under 18 or over 65 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo blood flow restriction therapy or standard physical therapy for Achilles injury rehabilitation

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Blood flow restriction

Trial Overview The study is testing Blood Flow Restriction (BFR) Therapy alongside regular physical therapy exercises to see if it helps improve strength and recovery in people rehabilitating from Achilles injuries. Participants will be randomly assigned to receive either BFR or just standard care.

Participant Groups

Group I: Blood flow restriction (BFR) therapy Experimental Treatment 1 Intervention

Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff.

Group II: Standard of Care Physical Therapy Active Control 1 Intervention

Patients with Achilles injury are prescribed PT for their treatment, therefore physical therapy is a standard of care treatment for patients with tendon pathology.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

Blood flow restriction training (BFRT) shows promising preliminary evidence for improving tendon health and clinical outcomes, based on a review of 13 studies involving various tendon conditions.

However, due to the limited number of studies and the variability in intervention parameters, more research is needed to establish definitive conclusions and recommendations for BFRT in tendon rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Resistance Training in Tendon Rehabilitation: A Scoping Review on Intervention Parameters, Physiological Effects, and Outcomes. Burton, I., McCormack, A.[2022]

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]

In a controlled study involving 40 rats, ischemic therapies like blood flow restriction therapy (BFRT) and repetitive restriction of muscle blood flow (RRMBF) did not lead to improvements in muscle mass, strength, or satellite cell density, suggesting limited efficacy for these methods in enhancing muscle function.

However, the RRMBF group showed significantly elevated growth hormone (GH) levels, indicating a potential biochemical response to this type of ischemic therapy, even though it did not translate to physical improvements in muscle characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local and Systemic Effects of Blood Flow Restriction Therapy in an Animal Model. Ramme, AJ., Darcy, R., Rourke, BJ., et al.[2020]

Blood flow restriction therapy (BFRT) uses a pneumatic cuff to restrict blood flow, creating a hypoxic environment that promotes muscle growth and strength gains, making it particularly beneficial for postoperative rehabilitation.

BFRT allows for effective low-load resistance training that achieves similar strength and hypertrophy results as higher-load training, but with less muscle swelling and pain, making it a safer option for those recovering from surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. Watson, R., Sullivan, B., Stone, A., et al.[2023]

Blood flow restriction training (BFRT) is generally safe for patients with musculoskeletal disorders, with a systematic review of 19 studies involving 322 participants showing that most did not report adverse events.

While some rare adverse events were noted, such as deep vein thrombosis and rhabdomyolysis, individuals undergoing BFRT did not experience more adverse events compared to those doing regular exercise, indicating its potential as a safe strengthening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Minniti, MC., Statkevich, AP., Kelly, RL., et al.[2020]

Blood flow restriction training (BFRT) can be beneficial for rehabilitation but poses risks such as increased blood pressure and adverse cardiovascular responses, especially in individuals with pre-existing conditions like hypertension and diabetes.

To ensure safety, a risk stratification tool is recommended for clinicians to assess patients' medical histories and identify those who may be at higher risk for complications when undergoing BFRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. Nascimento, DDC., Rolnick, N., Neto, IVS., et al.[2022]

In a study involving 52 participants, blood flow restriction (BFR) training during low-intensity exercise significantly reduced Achilles tendon thickness immediately after, 60 minutes, and 24 hours post-exercise, indicating a unique response to this training method.

In contrast, high-intensity exercise and low-intensity exercise without BFR did not change Achilles tendon thickness, suggesting that BFR may be an effective strategy for enhancing tendon adaptations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of Resistance Training with Blood Flow Restriction on Achilles Tendon Thickness. Picón-Martínez, M., Chulvi-Medrano, I., Cortell-Tormo, JM., et al.[2021]

Blood flow restriction therapy (BFRT) has been associated with a low incidence of adverse events, with only 1,672 out of 25,813 individuals reporting issues such as numbness, dizziness, and rhabdomyolysis, indicating it can be safely used in appropriate patient populations.

BFRT shows promise for enhancing rehabilitation and injury prevention, particularly in military settings, but further research is needed to establish its safety and efficacy comprehensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall Safety and Risks Associated with Blood Flow Restriction Therapy: A Literature Review. Anderson, KD., Rask, DMG., Bates, TJ., et al.[2022]

Blood flow restriction training (BFRT) was safely applied to two female athletes with shoulder pain, resulting in significant improvements in shoulder function, range of motion, and muscle strength after 16 to 22 treatment sessions.

The study suggests that BFRT could be an effective addition to traditional rehabilitation methods for managing subacromial pain, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training for Subacromial Pain: Two Case Reports. Miller, M., Zeppieri, G., Farmer, KW., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Resistance Training in Tendon Rehabilitation: A Scoping Review on Intervention Parameters, Physiological Effects, and Outcomes. [2022]

2. India pubmed.ncbi.nlm.nih.gov

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

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

Local and Systemic Effects of Blood Flow Restriction Therapy in an Animal Model. [2020]

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

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. [2023]

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

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. [2020]

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

A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

Acute Effects of Resistance Training with Blood Flow Restriction on Achilles Tendon Thickness. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Overall Safety and Risks Associated with Blood Flow Restriction Therapy: A Literature Review. [2022]

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

Blood Flow Restriction Training for Subacromial Pain: Two Case Reports. [2023]