Blood Flow Restriction Therapy for Shoulder Injury

(BFR Trial)

Overseen By Kristen Nicholson, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Age, Prior surgery, Others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Blood Flow Restriction Therapy might aid recovery from shoulder injuries, focusing on muscle loss and weakness. It compares two groups: one receiving the actual therapy and another receiving a "sham" version, which appears real but is inactive. The trial targets individuals with shoulder issues such as rotator cuff or biceps tendinopathy who have not undergone surgery on that shoulder and are willing to participate. Participants must be able to attend follow-up visits. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for shoulder injuries.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Blood Flow Restriction Therapy is safe for shoulder injury rehabilitation?

Research has shown that Blood Flow Restriction (BFR) Therapy is generally well-tolerated. BFR Therapy uses a tight band or cuff to reduce blood flow to muscles during exercise, which can help strengthen and grow muscles, especially after injuries.

A study from Houston Methodist found that BFR Therapy can enhance physical therapy for shoulder injuries by determining the right pressure to limit blood flow. The study did not report any serious side effects, suggesting BFR Therapy is relatively safe when performed correctly. However, discussing any concerns with a healthcare provider before starting a new treatment is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Blood Flow Restriction Therapy (BFR) for shoulder injuries because it offers a novel approach to rehabilitation. Unlike traditional methods like physical therapy and surgery, BFR uses pressurized cuffs to restrict blood flow, which can enhance muscle strength and recovery with less stress on the joints. This technique allows for effective muscle building at lower intensity levels, potentially speeding up recovery time. Additionally, by using a "sham" BFR group, researchers aim to isolate the specific benefits of actual blood flow restriction, providing clearer insights into its effectiveness.

What evidence suggests that Blood Flow Restriction Therapy is effective for shoulder injury?

Research has shown that Blood Flow Restriction Therapy (BFRT), which participants in this trial may receive, can greatly improve muscle strength and size, even with lighter exercise. Studies have found that BFRT leads to noticeable increases in muscle mass and strength, especially after shoulder injuries. For instance, twenty cadets who used BFRT experienced significant improvements after about 11 sessions over six weeks. Additionally, BFRT helps prevent muscle loss during periods of reduced activity, which often occur after shoulder injuries. This therapy works by partially limiting blood flow to the muscle, enhancing the effects of exercise and speeding up recovery. Participants in this trial may also receive a "sham" version of BFRT, serving as a comparator to evaluate the effectiveness of the actual BFRT. ^{3 4 5 6 7}

Who Is on the Research Team?

Kristen Nicholson, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals who have recently suffered from a shoulder injury. Specific details about eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

I have a shoulder injury diagnosed by MRI, not requiring surgery.

I am willing to participate in the study.

I have never had surgery on my arm on the same side or a deep vein clot.

Exclusion Criteria

I am unable to make my own medical decisions.

I have injuries to ligaments, tendons, or cartilage that could affect my rehab plan.

I have had surgery before on the same arm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of GH, IGF-1, IL-6 levels, and functional shoulder scores are taken

1 day

1 visit (in-person)

Treatment

Participants undergo Blood Flow Restriction (BFR) therapy or sham BFR therapy as part of rehabilitation

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for changes in shoulder muscle strength and functional scores

6-12 months

Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Blood Flow Restriction Therapy
• Sham Blood Flow Restriction

Trial Overview The study is examining the effectiveness of Blood Flow Restriction Therapy in preventing muscle loss after a shoulder injury. Participants will be randomly assigned to receive either actual Blood Flow Restriction or a 'sham' version that mimics the treatment without active intervention.

How Is the Trial Designed?

Group I: Blood Flow Restriction (BFR) Experimental Treatment 1 Intervention

Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol

Group II: "sham" Blood Flow Restriction (BFR) Placebo Group 1 Intervention

rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol

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?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

Blood flow restriction (BFR) training is considered a safe and effective method for improving musculoskeletal training outcomes, supported by 25 years of research.

There is a need for standardized, evidence-based protocols for BFR training among health professionals in South Africa to ensure its proper and safe application during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in South Africa - a panel discussion. Evans, RW., Ganda, J., van Schalkwyk, L., et al.[2023]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11987155/

Effects of exercise therapy with blood flow restriction on ... Blood flow restriction therapy (BFRT) has gained attention for its capacity to induce substantial muscle hypertrophy and strength gains even when employing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9981204/

The Effect of Blood Flow Restriction Therapy on Shoulder ... Twenty cadets performed an average 10.9 BFR training sessions over six weeks. Statistically significant and clinically meaningful increases in ...

3. houstonmethodist.org houstonmethodist.org/leading-medicine-blog/articles/2023/oct/blood-flow-restriction-study-identifies-optimal-occlusion-pressure-for-shoulder-rehabilitation/

Blood Flow Restriction Study Identifies Optimal Occlusion ... A Houston Methodist study confirms blood flow restriction enhances physical therapy after shoulder injury and identifies ideal occlusion ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05506072

Blood Flow Restriction Training Versus Standard Physical ... The purpose of this Randomized Controlled Trial is to evaluate the effectiveness of Blood Flow Restriction (BFR) training with standard care of physical therapy ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X24001652

Blood Flow Restriction Training: A Tool to Enhance ... BFRT facilitates gains in muscular strength and hypertrophy at lower loads, allowing for accelerated recovery and less disuse atrophy. BFRT must be applied ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8811521/

Blood Flow Restriction Therapy and Its Use for ... Blood flow restriction (BFR) is an expanding rehabilitation modality that uses a tourniquet to reduce arterial inflow and occlude venous outflow.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34110960/

Blood Flow Restriction Training for the Shoulder: A Case ... Conclusion: Combined BFR-LIX may yield greater increases in shoulder and arm lean mass, strength, and muscular endurance compared with fatiguing ...