Actively Recruiting
Blood Flow Restriction Training for Subacromial Pain: A Pilot Randomized Controlled Trial
Led by University of Florida · Updated on 2025-07-08
36
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating blood flow restriction training (BFRT) to see if it is safe and practical for people experiencing subacromial shoulder pain. This pilot clinical trial aims to learn what challenges patients might face when training with BFRT, whether BFRT can be included in physical therapy, and its early effects on shoulder function and strength recovery. The study compares active BFRT to a sham procedure that mimics the training but without therapeutic pressure. Participants will be randomly assigned to either the active BFRT group, where a device applies 50% of limb occlusion pressure during strengthening exercises, or the sham BFRT group, which uses a device set to 20mmHg pressure. Both groups perform four specific strengthening exercises with the BFRT device and receive skilled physical therapy care including warm-up, stretching, mobilizations, and cryotherapy. Physical therapy lasts at least 4 weeks, with ongoing BFRT exercises continuing up to 8 weeks. Participants will visit the clinic for physical therapy sessions and BFRT exercises over 8 weeks. Assessments occur before treatment, midway at 4 weeks, at the end of treatment (8 weeks), and again at 26 weeks. Researchers will monitor recruitment, feasibility, safety, retention, shoulder range of motion, strength, muscle size, tendon health, and patient-reported outcomes. The trial’s total follow-up spans about 6 months to evaluate progress and effects of the interventions.
CONDITIONS
Brief Title
BFRT for Subacromial Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 50 years of age
- Unilateral pain in the anterolateral shoulder
- Self-reported shoulder function of 7 or less on a 10-point scale
- Ability to actively raise the shoulder at least 90 degrees
- At least 3 out of 5 positive clinical tests indicating subacromial pain
You will not qualify if you...
- History of shoulder fracture, frozen shoulder, or shoulder surgery
- Primary complaint of shoulder instability or dislocation
- History of cardiovascular, neurological, or pulmonary conditions limiting physical therapy participation
- Active cancer treatment
- Uncontrolled diabetes
- Uncontrolled high blood pressure
- Corticosteroid injection in the shoulder within the past 6 weeks
- Imaging evidence of rotator cuff tears
- Pregnancy
- Contraindications to blood flow restriction training such as sickle cell anemia, deep vein thrombosis, or peripheral circulatory diseases
- Use of anticoagulant or antiplatelet medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants perform strengthening exercises using a blood flow restriction device combined with skilled physical therapy care. The device is applied to the involved upper extremity with different pressure settings depending on the study group. Strengthening exercises include four specific shoulder movements performed with controlled resistance and rest periods. Participants receive skilled physical therapy interventions including warm-up, range of motion, stretching, joint mobilizations, and cryotherapy for a minimum of 4 weeks. Following physical therapy discharge, participants continue the strengthening exercises with the device until the end of the 8-week treatment period.
Weekly visits for up to 8 weeks
Duration - Up to 26 weeks after enrollment
Participants are monitored for retention, safety, and functional outcomes including range of motion, strength, and shoulder function up to 26 weeks after enrollment.
Visits at 4 weeks, 8 weeks, and 6 months
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
F
Federico Pozzi, PT, MA, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here