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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether blood flow restriction training can help individuals with shoulder pain, specifically subacromial pain, a common shoulder condition. Researchers aim to determine if this training is safe and practical as part of physical therapy. Participants will undergo either active blood flow restriction training or a sham procedure for comparison. The trial seeks participants who have shoulder pain in one shoulder, can lift their arm at least 90 degrees, and meet specific test criteria related to subacromial pain. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance physical therapy options for shoulder pain.

Will I have to stop taking my current medications?

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

What prior data suggests that blood flow restriction training is safe for patients with shoulder pain?

Research has shown that blood flow restriction training (BFRT) is generally safe and well-tolerated. One study found it safe to use during the early stages of healing after an injury, indicating it does not harm tissues that are still repairing. Other research indicates that BFRT can help increase muscle strength and size, which is promising for those in rehabilitation.

Most studies focus on how BFRT works and its benefits, reporting that side effects or problems are rare. However, as with any treatment, individual experiences can vary. Overall, the available evidence suggests that BFRT is a safe option for managing shoulder pain and improving muscle health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Blood Flow Restriction Training (BFRT) is unique because it offers a novel approach to managing shoulder pain by partially restricting blood flow during low-intensity exercises. While traditional treatments like physical therapy, anti-inflammatory medications, and sometimes surgery focus on reducing pain and inflammation or repairing tissues, BFRT aims to enhance muscle strength and growth with less strain on the body. Researchers are excited about BFRT because it may allow patients to achieve similar or even superior outcomes with reduced exercise intensity, potentially leading to quicker recovery times and fewer complications.

What evidence suggests that blood flow restriction training is effective for shoulder pain?

Research has shown that blood flow restriction training, which participants in this trial may receive, can help strengthen muscles and improve function, particularly in the arms. Studies have found that this method supports muscle growth and reduces pain. For individuals recovering from shoulder surgery, this training led to significant improvements in shoulder strength and movement. Specifically, another study found that participants experienced noticeable improvements in physical performance after several sessions. Overall, the evidence suggests that blood flow restriction training could be a promising way to enhance shoulder function and reduce pain. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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) 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]

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 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]

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]

Citations

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

Effects of exercise therapy with blood flow restriction on ... It strengthens muscles, improves function and endurance, and alleviates pain. Several recent studies have investigated the effects of upper limb ...

2. 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 ...

3. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/37865-the-effect-of-blood-flow-restriction-therapy-on-shoulder-function-following-shoulder-stabilization-surgery-a-case-series

The Effect of Blood Flow Restriction Therapy on Shoulder ... After shoulder stabilization surgery, significant improvements in shoulder strength, self-reported function, and ROM were observed with six ...

4. 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 ...

5. 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 ...

6. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/118143-effects-of-low-load-blood-flow-restriction-training-on-rotator-cuff-strength-and-hypertrophy-case-series

Effects of Low-Load Blood Flow Restriction Training on ... The purpose of this case series is to explore the effects of low-load BFRT on RC strength, hypertrophy, and tendon thickness in asymptomatic individuals.

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

Blood Flow Restriction Training: A Tool to Enhance ... Blood flow restriction training (BFRT) is a tool utilized in rehabilitation and injury prevention to improve muscle strength and size.

8. mdpi.com mdpi.com/2075-4663/11/10/197

Blood Flow Restriction Training in Nonspecific Shoulder Pain This study aims to examine whether a single BFR session with low-load exercises can alleviate pain perception among nonspecific shoulder pain patients.