36 Participants Needed

Blood Flow Restriction Training for Shoulder Pain

FP
Overseen ByFederico Pozzi, PT, MA, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.14678

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.12379

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.
See 1 more

Exclusion Criteria

Imaging evidence of rotator cuff tears
Pregnancy
My diabetes is not under control.
See 7 more

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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active BFRTExperimental Treatment3 Interventions
Group II: Sham BFRTPlacebo Group3 Interventions

Find a Clinic Near You

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

References

Blood Flow Restriction Training for Subacromial Pain: Two Case Reports. [2023]
Blood Flow Restriction Training in Patients With Rotator Cuff Tendinopathy: A Randomized, Assessor-Blinded, Controlled Trial. [2023]
Blood Flow Restriction Training in Rehabilitation: A Useful Adjunct or Lucy's Latest Trick? [2020]
Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial. [2020]
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]
The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. [2020]
Blood flow restriction training in South Africa - a panel discussion. [2023]
A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. [2022]
[Blood flow restriction training as a treatment option for lateral elbow tendinopathy-a study presentation]. [2023]
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