BFRT for Subacromial Pain

University of Florida

Status: Enrolling

Conditions: Shoulder Pain

Treatments: Device: Active BFRT; Behavioral: Strengthening Exercises with BFRT; Device: Sham BFRT; Behavioral: Skilled Physical Therapy Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06873113

IRB202302184

R21AR082588-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
• primary complaint of shoulder instability/dislocation
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Active BFRT

Experimental group

Treatment:

Behavioral: Skilled Physical Therapy Care

Behavioral: Strengthening Exercises with BFRT

Device: Active BFRT

Sham BFRT

Sham Comparator group

Treatment:

Behavioral: Skilled Physical Therapy Care

Behavioral: Strengthening Exercises with BFRT

Device: Sham BFRT