Trials Today

BFRT for Subacromial Pain

Purpose

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).

Condition

Shoulder Pain

Eligibility

Eligible Ages: Between 18 Years and 50 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Other
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Active BFRT		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. 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).
Sham Comparator Sham BFRT		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).

Recruiting Locations

University of Florida
Gainesville, Florida 32610

Contact:
Shea Herlihy, MS
352-273-7361
herliso@ortho.ufl.edu

More Details

NCT ID: NCT06873113
Status: Recruiting
Sponsor: University of Florida

Study Contact

Federico Pozzi, PT, MA, PhD
(352) 273-6957
fpozzi@phhp.ufl.edu