Clinical trial NCT06873113: BFRT for Subacromial Pain
Official title: Blood Flow Restriction Training for Subacromial Pain: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Keywords: blood flow restriction training
BFRT
BFR
exercise
subacromial pain
rotator cuff tendinopathy
subacromial impingement
rotator cuff related shoulder pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2025-03-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


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
* 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

Primary outcomes:
measure: Recruitment
timeFrame: Monthly report from beginning to completion of recruitment (anticipated 2 years)
measure: Intervention feasibility
timeFrame: Weekly record from enrollment to the end of treatment at 8 weeks.
Secondary outcomes:
measure: Retention
timeFrame: Weekly record from enrollment to 26 weeks (end of the trial).
measure: Intervention safety
timeFrame: Weekly record from enrollment to 26 weeks (end of the trial).
measure: Participants masking feasibility
timeFrame: At 8 weeks
measure: Patient acceptability
timeFrame: At 8 weeks
measure: Range of motion
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Strength
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Timed Functional Arm and Shoulder Test (TFAST)
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Supraspinatus and infraspinatus muscle cross-sectional area
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Supraspinatus tendon morphology
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Supraspinatus tendon elastography
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Pennsylvania Shoulder Score (PENN)
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Global rating of change (GROC)
timeFrame: At 4 weeks, 8 weeks and 6 months
measure: Patient specific functional scale (PSFS)
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
Other outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Brief Pain Inventory (BPI)
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Patient Acceptable Symptoms State (PASS)
timeFrame: At 8 weeks and 6 months
measure: Pressure pain sensitivity
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Quick Disability of the Arm and Shoulder (Q-DASH)
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Infraspinatus tendon morphology
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Infraspinatus tendon elastography
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
measure: Optimal Screening for Prediction of Referral and Outcome (OSPRO)
timeFrame: From enrollment to 4 weeks, 8 weeks and 6 months
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: