Recruiting

BFRT

Sponsor:

University of Florida

Code:

NCT06873113

Conditions

Shoulder Pain

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Active BFRT

Sham BFRT

Strengthening Exercises with BFRT

Skilled Physical Therapy Care

Study Details

Brief 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).

Conditions

Shoulder Pain

Study ID

NCT06873113

Start date

May 13, 2025

Status verified date

May, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Active BFRT

sham comparator: Sham BFRT

Interventions

Active BFRT

The BFR device is applied unilaterally on participants involved upper extremity. The BFR device maintains 50% of participants limb occlusion pressure for the duration of each strengthening exercise.

Sham BFRT

The BFR device is applied unilaterally on participants involved upper extremity. The BFR device maintains a pressure of 20mmHg for the duration of each strengthening exercise.

Strengthening Exercises with BFRT

Participants perform 4 strengthening exercises while using the BFR device: seated scapular plane elevation, prone horizontal abduction, side-lying external rotation, and prone scapular plane elevation. Each exercise is performed unilaterally. Participants perform 1 set of 30 repetitions followed by 3 sets of 15 repetitions (4 total sets, 75 total repetitions). Participants are given 30 seconds rest between sets and 2 minutes of rest between strengthening exercises. Selected resistance for each strengthening exercise is equal to 20% of the participant's maximal force production as measured by handheld dynamometry. Resistance is adjusted weekly.

Skilled Physical Therapy Care

Participants perform non-strengthening interventions as part of skilled physical therapy care. Non-strengthening interventions include an upper arm ergometer for warm-up, active assisted range of motion of the shoulder, shoulder stretching, shoulder joint mobilizations, and cryotherapy. Non-strengthening interventions are prescribed at the discretion of the treating physical therapist. Participants are enrolled in physical therapy for a minimum of 4 weeks. After 4 weeks, the treating physical therapist can discharge a participant based on their progress in meeting their rehabilitation goals. Participants discharged from skilled physical therapy care will continue to complete strengthening exercises with BFRT until the end of the trial period (8 weeks).

Primary outcome measure

  • Recruitment [ Time Frame: Monthly report from beginning to completion of recruitment (anticipated 2 years) ]
  • Intervention feasibility [ Time Frame: Weekly record from enrollment to the end of treatment at 8 weeks. ]

Central Contacts and Locations

Central contacts

Federico Pozzi, PT, MA, PhD

(352) 273-6957fpozzi@phhp.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Shea Herlihy, MS

352-273-7361herliso@ortho.ufl.edu

Principal Investigator:

Federico Pozzi, PT, MA, PhD

More Information

Sponsor

University of Florida

Last update posted

Jul 8, 2025

Last verified

May, 2025

Keywords

  • blood flow restriction training
  • BFRT
  • BFR
  • exercise
  • subacromial pain
  • rotator cuff tendinopathy
  • subacromial impingement
  • rotator cuff related shoulder pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-07-08.