BFRT for Subacromial Pain

Last updated: May 1, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Skilled Physical Therapy Care

Sham BFRT

Active BFRT

Clinical Study ID

NCT06873113
IRB202302184
R21AR082588-01A1
  • Ages 18-50
  • All Genders

Study Summary

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

Inclusion

Inclusion criteria

  • Between 18 and 50 years of age

  • Unilateral pain in the anterolateral shoulder

  • Self-reported shoulder function of ≤7 (10, full function)

  • At least 90° of active shoulder elevation

  • 3 out of 5 positive tests to define subacromial pain.

Exclusion Criteria (general):

  • history of shoulder fracture, frozen shoulder, or shoulder surgery

  • history of cardiovascular, neurologic, and pulmonary conditions that would impair the subject's ability to participate in physical therapy

  • active treatment for cancer

  • uncontrolled diabetes

  • uncontrolled high blood pressure

  • corticosteroid injection at the shoulder within 6 weeks

  • imaging evidence of rotator cuff tears

  • pregnancy

Exclusion criteria (Blood flow restriction training specific)

  • contraindications to BFRT (sickle cell anemia, deep vein thrombosis, peripheral circulatory diseases)

  • taking anticoagulant or antiplatelet drugs

Study Design

Total Participants: 36
Treatment Group(s): 4
Primary Treatment: Skilled Physical Therapy Care
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

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