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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to aid recovery from Achilles tendon injuries using blood flow restriction (BFR) therapy. BFR uses a special cuff to limit blood flow during light exercises, which can enhance strength. Participants will join one of two groups: one receiving standard physical therapy and the other undergoing BFR therapy. This trial suits individuals diagnosed with an Achilles injury who plan to undergo physical therapy.

As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods.

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 prior data suggests that blood flow restriction therapy is safe for Achilles tendon injury rehabilitation?

Research has shown that blood flow restriction (BFR) therapy is safe and aids individuals with orthopedic issues, such as those recovering from surgery, in gaining strength. Studies have found BFR therapy effective in promoting tendon healing.

For instance, one study discovered that BFR therapy improved tendon function more than a similar therapy without blood flow restriction. Another study found that BFR therapy increased tendon thickness and stiffness, indicators of healing. This therapy involves placing a cuff on the limb and adjusting the pressure, and participants in these studies tolerated it well.

Overall, no major safety concerns have been reported, and BFR therapy is considered a safe and effective method for strengthening muscles and tendons. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Blood flow restriction (BFR) therapy is unique because it uses a special cuff to restrict blood flow to the injured Achilles tendon, creating a low-oxygen environment that can stimulate muscle growth and strength. Unlike the standard physical therapy that primarily focuses on exercises to gradually build strength, BFR offers a novel approach by enhancing muscle adaptation and recovery even with lower intensity exercises. Researchers are excited about BFR because it could potentially speed up recovery times and improve outcomes for tendon injuries, providing an innovative alternative to traditional rehabilitation methods.

What evidence suggests that blood flow restriction therapy is effective for Achilles injuries?

Research has shown that blood flow restriction (BFR) therapy, one of the treatments studied in this trial, can improve tendon health and function. Studies have found that BFR therapy strengthens the Achilles tendon similarly to lifting heavy weights, but without the need for heavy weights. Some reports also indicate that BFR therapy reduces pain and enhances movement for individuals with tendon issues. Even with short-term use, patients have experienced improved strength and blood flow in their tendons. This trial will compare BFR therapy to standard care physical therapy, another treatment arm in the study. Overall, BFR therapy appears to be a promising method for recovering from Achilles injuries. ^{1 2 4 6 7}

Who Is on the Research Team?

Guillem Gonzalez-Lomas, MD

Principal Investigator

New York Langone Health

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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) 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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9083008/

Blood Flow Restriction Training for Tendon Rehab Data were extracted on physiological tendon effects, intervention parameters and outcomes with BFRT. Results. Thirteen studies were included, three on ...

2. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08734-5

Blood Flow Restriction Training: Tendon Adaptation & Rehab Additionally, five case reports using BFRT demonstrated improvements in functional outcomes and pain [35, 48,49,50,51]. However, one study ...

3. journals.physiology.org journals.physiology.org/doi/abs/10.1152/japplphysiol.00602.2019

Low-load BFR training vs. high-load resistance training Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12096532/

Blood Flow Restriction Training for Tendon Adaptation & Rehab BRFT produced significantly better results compared to LLRT-sham for all primary outcomes and at 6 and 12weeks. Patients in BRFT group had ...

5. mdpi.com mdpi.com/2674-0621/3/1/3

Blood Flow Restriction Training for Tendinopathy Rehabilitation Despite the intervention being short-term, all patients improved clinical outcomes (pain and function), strength (dynamometry), and tendon vascularity ( ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1360859223002565

Effects of low-load blood flow restriction training in healthy ... LL-BFR decreases the Achilles tendon thickness immediately after exercise. LL-BFR increase the tendon thickness and stiffness after a > 8-week intervention.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04104126

Blood Flow Restriction Therapy in Achilles Injury It is a safe and effective method of improving strength in healthy and active individuals, recovering from orthopedic pathologies and procedures. This ...