BFRT for Subacromial Pain

Not Applicable

Recruiting

• Conditions: Shoulder Pain

• Registration Number: NCT06873113
• Lead Sponsor: University of Florida

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Study Start: 2025-06-01
• Primary Completion: 2027-03-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention feasibility	Weekly record from enrollment to the end of treatment at 8 weeks.	The interventionist team will complete standardized notes of the intervention, which will be reviewed weekly to document adherence and protocol fidelity and for early identification of intervention deviations. Outcomes include the number of patients a) completing at least 80% of the assigned BFRT visits, b) requesting to stop BFRT within a session, c) requesting to withdraw from the intervention, and d) requesting to switch intervention arms. The last number is a proxy for patients who do not accept randomization results.
Recruitment	Monthly report from beginning to completion of recruitment (anticipated 2 years)	Record the number of individuals a) approached, b) screened, c) qualified, and d) willing to participate. The reasons for participants who do not qualify or refuse to participate will be recorded.

Secondary Outcome Measures

Name	Time	Method
Retention	Weekly record from enrollment to 26 weeks (end of the trial).	Identify the number of dropouts and reasons impacting participation in follow-up visits.
Intervention safety	Weekly record from enrollment to 26 weeks (end of the trial).	Monitor the occurrance of severe adverse events and exercise-related adverse events.
Participants masking feasibility	At 8 weeks	At the primary endpoint, participants will be asked to guess the treatment allocation to evaluate participant masking feasibility.
Patient acceptability	At 8 weeks	A guided interview using Likert scale-type and open-ended questions will be conducted to gather participant feedback on trial and intervention procedures. An electronic copy of this questionnaire will be sent to patients who withdraw/stop showing up to understand whether trial or intervention procedures impact patient retention.
Range of motion	From enrollment to 4 weeks, 8 weeks and 6 months	The investigators will measure range of motion using an inclinometer or goniometer. The investigators will measure shoulder elevation in the scapular plane, external rotation, and internal rotation. The investigators will also measure coronal, axial, and sagittal rotation of the scapula during shoulder elevation in the scapular plane.
Strength	From enrollment to 4 weeks, 8 weeks and 6 months	The investigators will measure shoulder elevation in the scapular plane and external rotation strength using a handheld dynamometer.
Timed Functional Arm and Shoulder Test (TFAST)	From enrollment to 4 weeks, 8 weeks and 6 months	It includes three tasks: an internal/external rotation task (duration 30s), an outward circular motion task (duration 30s), and a gallon-lift task at the height of a standard counter (duration 30s). In each task, participants repeat movements as fast as possible.
Supraspinatus and infraspinatus muscle cross-sectional area	From enrollment to 4 weeks, 8 weeks and 6 months	The investigators will use ultrasound to take pictures of the supraspinatus and infraspinatus muscles. This outcome represents a marker of hypertrophy, a potential mechanism of strengthening.
Supraspinatus tendon morphology	From enrollment to 4 weeks, 8 weeks and 6 months	The investigators will use ultrasound to take pictures of the supraspinatus tendons. Established ultrasound procedures will be used to measure supraspinatus tendon thickness.
Supraspinatus tendon elastography	From enrollment to 4 weeks, 8 weeks and 6 months	Ultrasound will be used to take pictures of the supraspinatus tendons. The investigators will set the ultrasound parameters to elastography, allowing non-invasive measurement of tendon stiffness and elasticity.
Pennsylvania Shoulder Score (PENN)	From enrollment to 4 weeks, 8 weeks and 6 months	The PENN is a valid and reliable self-reported questionnaire for patients with shoulder pain.
Global rating of change (GROC)	At 4 weeks, 8 weeks and 6 months	The GROC is a rating scale that quantifies participants' improvement or deterioration of symptoms over time. Changes will be measured using a 15-points Likert scale (-7, a very great deal worse to 7, a very great deal better, with 0 indicating no changes).
Patient specific functional scale (PSFS)	From enrollment to 4 weeks, 8 weeks and 6 months	The PSFS asks patients to rate their difficulty performing three activities of their choice. It is advantageous because it asks patients to select the activities rather than providing pre-selected options.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States