BFRT for Subacromial Pain

Official title

Blood Flow Restriction Training for Subacromial Pain: A Pilot Randomized Controlled Trial

Overview

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).

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 s
• 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 th

Primary outcome measures

• 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.]

Secondary outcome measures (12)

• Retention [Time frame: Weekly record from enrollment to 26 weeks (end of the trial).]
• Intervention safety [Time frame: Weekly record from enrollment to 26 weeks (end of the trial).]
• Participants masking feasibility [Time frame: At 8 weeks]
• Patient acceptability [Time frame: At 8 weeks]
• Range of motion [Time frame: From enrollment to 4 weeks, 8 weeks and 6 months]
• Strength [Time frame: From enrollment to 4 weeks, 8 weeks and 6 months]
• Timed Functional Arm and Shoulder Test (TFAST) [Time frame: From enrollment to 4 weeks, 8 weeks and 6 months]
• Supraspinatus and infraspinatus muscle cross-sectional area [Time frame: From enrollment to 4 weeks, 8 weeks and 6 months]
• Supraspinatus tendon morphology [Time frame: From enrollment to 4 weeks, 8 weeks and 6 months]
• Supraspinatus tendon elastography [Time frame: From enrollment to 4 weeks, 8 weeks and 6 months]
• Pennsylvania Shoulder Score (PENN) [Time frame: From enrollment to 4 weeks, 8 weeks and 6 months]
• Global rating of change (GROC) [Time frame: At 4 weeks, 8 weeks and 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

United States · 1 center

• University of Florida — Gainesville

Identifiers

NCT: NCT06873113 · IRB202302184 · R21AR082588-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗