BFRT for Subacromial Pain
Blood Flow Restriction Training for Subacromial Pain: A Pilot Randomized Controlled Trial
2 other identifiers
interventional
36
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2025
CompletedFirst Posted
Study publicly available on registry
March 12, 2025
CompletedStudy Start
First participant enrolled
May 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 8, 2025
May 1, 2025
1.9 years
March 3, 2025
July 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recruitment
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.
Monthly report from beginning to completion of recruitment (anticipated 2 years)
Intervention feasibility
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.
Weekly record from enrollment to the end of treatment at 8 weeks.
Secondary Outcomes (13)
Retention
Weekly record from enrollment to 26 weeks (end of the trial).
Intervention safety
Weekly record from enrollment to 26 weeks (end of the trial).
Participants masking feasibility
At 8 weeks
Patient acceptability
At 8 weeks
Range of motion
From enrollment to 4 weeks, 8 weeks and 6 months
- +8 more secondary outcomes
Other Outcomes (8)
Western Ontario Rotator Cuff Index (WORC)
From enrollment to 4 weeks, 8 weeks and 6 months
Brief Pain Inventory (BPI)
From enrollment to 4 weeks, 8 weeks and 6 months
Patient Acceptable Symptoms State (PASS)
At 8 weeks and 6 months
- +5 more other outcomes
Study Arms (2)
Active BFRT
EXPERIMENTALSham BFRT
SHAM COMPARATORInterventions
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.
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.
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.
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).
Eligibility Criteria
You may qualify if:
- 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
- out of 5 positive tests to define subacromial pain.
You may not qualify if:
- 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
- contraindications to BFRT (sickle cell anemia, deep vein thrombosis, peripheral circulatory diseases)
- taking anticoagulant or antiplatelet drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2025
First Posted
March 12, 2025
Study Start
May 13, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
July 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Study protocol \& statistical analysis plan: A manuscript describing the study protocol and statistical analysis plan will be submitted for publication within the first year of starting the clinical trial. Clinical study report and analytic code: Individual data and analytic code will be made available after the publication of the primary results of this trial.
- Access Criteria
- Study protocol and statistical analysis plan: The manuscript will be published as open access. Clinical study report and analytic code: Data will be shared on NIH/NIAMS approvved data repository (i.e., Dataverse). Access will follow repository guidelines.