Blood Flow Restriction Training for Shoulder Pain

Overseen By Federico Pozzi, PT, MA, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Shoulder surgery, Cardiovascular, Diabetes, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulant or antiplatelet drugs to participate.

What data supports the effectiveness of the treatment Blood Flow Restriction Training for shoulder pain?

Research suggests that Blood Flow Restriction Training (BFRT) can help strengthen shoulder muscles and improve symptoms in conditions like rotator cuff tendinopathy, which is a type of shoulder pain. This training method uses low-weight exercises with a special cuff to restrict blood flow, potentially leading to strength gains similar to high-weight exercises but with less stress on the tissues. ^{1 2 3 4 5}

Is blood flow restriction training generally safe for humans?

Blood flow restriction training (BFRT) has been shown to be relatively safe over the past 25 years, but it can cause increased blood pressure and other cardiovascular responses. It is important to use caution, especially for people with existing health issues like heart disease, high blood pressure, or diabetes, and a risk assessment is recommended before starting BFRT. ^{1 4 6 7 8}

How is blood flow restriction training different from other treatments for shoulder pain?

Blood flow restriction training is unique because it involves performing low-intensity exercises while wearing a cuff that restricts blood flow, which can lead to muscle strengthening and pain reduction without the need for heavy weights. This makes it particularly suitable for individuals who cannot handle high training loads, such as those recovering from injury or surgery. ^{1 2 3 7 9}

What is the purpose of this trial?

The goal of this pilot clinical trial is to learn if blood flow restriction training is safe and feasible in patients with subacromial pain. The main questions the investigators aim to answer are: * What problems do participants with shoulder pain encounter when training with blood flow restriction? * Is it feasible to apply blood flow restriction training as part of a physical therapy intervention? * What are some preliminary effects of blood flow restriction training on the recovery of shoulder function and strength? The investigators will compare active blood flow restriction training to sham (an inactive procedure designed to mimic the active training as closely as possible). Participants will: * Visit the clinic for physical therapy visits and exercise with blood flow restriction training for up to 8 weeks * Visit the clinic for tests before starting the treatment, during the treatment (4 weeks), and after the end of the treatment (8 and 26 weeks).

Eligibility Criteria

This trial is for individuals experiencing subacromial shoulder pain. Participants will engage in physical therapy and exercises with blood flow restriction (BFRT) for up to 8 weeks, with clinic visits before, during, and after treatment to assess progress.

Inclusion Criteria

3 out of 5 positive tests to define subacromial pain

I can lift my arm above my head.

I have pain on one side of my shoulder towards the front.

Exclusion Criteria

Imaging evidence of rotator cuff tears

Pregnancy

My diabetes is not under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive blood flow restriction training as part of physical therapy for up to 8 weeks

8 weeks

Weekly visits for physical therapy and exercise

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

Visits at 8 weeks and 26 weeks post-treatment

Treatment Details

Interventions

• Blood Flow Restriction Training

Trial Overview The study aims to determine the safety and feasibility of BFRT in treating shoulder pain. It involves comparing active BFRT against a sham procedure that simulates the training without actual restriction, as part of skilled physical therapy care.

Participant Groups

Group I: Active BFRT Experimental Treatment 3 Interventions

Group II: Sham BFRT Placebo Group 3 Interventions

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

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]

Blood flow restriction training, which involves low-intensity exercise while wearing a blood pressure cuff, is proposed to enhance strength gains and improve performance, despite skepticism from physical therapists about its effectiveness.

This training method may also lead to shorter recovery times and reduced pain after exercise, suggesting potential benefits for rehabilitation and performance enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training in Rehabilitation: A Useful Adjunct or Lucy's Latest Trick? Whiteley, R.[2020]

In a study involving 24 healthy subjects, low-weight training combined with blood flow restriction (BFR) resulted in significantly greater strength gains in both proximal and distal muscle groups compared to low-weight training without BFR, with increases in shoulder strength by up to 30%.

BFR training also led to significant increases in arm and forearm circumferences, indicating enhanced muscle hypertrophy, while no adverse events were reported, suggesting that this method is safe for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial. Bowman, EN., Elshaar, R., Milligan, H., et al.[2020]

Low load blood flow restriction training (LL-BFRT) significantly improves upper limb strength and muscle size compared to low load resistance training (LL-RT), but not compared to high load resistance training (HL-RT).

The evidence for these findings is of low certainty, indicating that while LL-BFRT can be effective, its benefits in muscle size and strength may not be superior to traditional resistance training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of upper body blood flow restriction training on muscles located proximal to the applied occlusive pressure: A systematic review with meta-analysis. Pavlou, K., Korakakis, V., Whiteley, R., 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 (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]

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) combines low load resistance training with partial arterial and complete venous occlusion to promote muscle growth and strength, making it ideal for individuals recovering from injuries or surgeries.

The article discusses an ongoing randomized controlled trial investigating the effectiveness of BFRT specifically for treating lateral elbow tendinopathy, highlighting its potential therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Blood flow restriction training as a treatment option for lateral elbow tendinopathy-a study presentation]. Hinz, M., Franz, A., Pirker, C., et al.[2023]

References

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

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

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

Blood Flow Restriction Training in Patients With Rotator Cuff Tendinopathy: A Randomized, Assessor-Blinded, Controlled Trial. [2023]

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

Blood Flow Restriction Training in Rehabilitation: A Useful Adjunct or Lucy's Latest Trick? [2020]

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

Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial. [2020]

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

The effects of upper body blood flow restriction training on muscles located proximal to the applied occlusive pressure: A systematic review with meta-analysis. [2023]

6. 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]

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

[Blood flow restriction training as a treatment option for lateral elbow tendinopathy-a study presentation]. [2023]