BFRT for Subacromial Pain

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

Interventions

DEVICE

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.

DEVICE

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.

BEHAVIORAL

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.

BEHAVIORAL

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).

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• University of Florida

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-13

Primary Completion

2027-03-31

Completion

2028-12-31

FDA Device

Yes

Countries

• United States

Study Locations