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

24 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Blood Flow Restriction Therapy for shoulder injury?

Blood flow restriction therapy has shown benefits in improving strength, endurance, and reducing pain for various musculoskeletal injuries, and it may help strengthen shoulder muscles, although most research focuses on lower body applications. ^{1 2 3 4 5}

Is Blood Flow Restriction Therapy safe for humans?

Blood Flow Restriction Therapy (BFR) is generally considered safe for humans, including those with neurologic conditions, as no side-effects requiring medical attention have been reported. However, some people may experience discomfort from the pressure, and more research is needed to fully understand its safety across different conditions. ^{1 3 6 7 8}

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

Blood Flow Restriction Therapy is unique because it involves restricting blood flow to the muscles during low-load exercises, which can enhance muscle strength and size without the need for heavy weights. This approach is particularly novel for shoulder injuries, as it has primarily been used for lower body rehabilitation. ^{1 2 3 6 9}

What is the purpose of this trial?

Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.

Research Team

Kristen Nicholson, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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) 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 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]

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 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]

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 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]

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]

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

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

3. 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]

4. 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]

5. South Africa pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in South Africa - a panel discussion. [2023]

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

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

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

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

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