Shoulder PainNCT06873113
BFRT for Subacromial Pain
A study testing Active BFRT, Strengthening Exercises with BFRT and Skilled Physical Therapy Care in people with Shoulder Pain, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Active BFRT, Strengthening Exercises with BFRT and Skilled Physical Therapy Care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Shea Herlihy, MS, 352-273-7361, herliso@ortho.ufl.edu
Federico Pozzi, PT, MA, PhD
About this study
Official title: Blood Flow Restriction Training for Subacromial Pain: A Pilot Randomized Controlled Trial
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?
Read more
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).
- Conditions
- Shoulder Pain
- Being tested
- Active BFRT, Sham BFRT, Strengthening Exercises with BFRT, Skilled Physical Therapy Care
- Keywords
- blood flow restriction training, BFRT, BFR, exercise, subacromial pain, rotator cuff tendinopathy, subacromial impingement, rotator cuff related shoulder pain
- Medical subject headings
- Shoulder Pain, Motor Activity, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active BFRTDevice
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.
Sham BFRTDevice
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.
Strengthening Exercises with BFRTBehavioural
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.
Skilled Physical Therapy CareBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Active BFRT | Experimental | Not described Receives: Device: Active BFRT; Behavioral: Strengthening Exercises with BFRT; Behavioral: Skilled Physical Therapy Care |
| Sham BFRT | Sham comparator | Not described Receives: Device: Sham BFRT; Behavioral: Strengthening Exercises with BFRT; Behavioral: Skilled Physical Therapy Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Weekly record from enrollment to the end of treatment at 8 weeks.
Secondary outcomes (13)
Retention
Identify the number of dropouts and reasons impacting participation in follow-up visits.
Measured: Weekly record from enrollment to 26 weeks (end of the trial).
Intervention safety
Monitor the occurrance of severe adverse events and exercise-related adverse events.
Measured: Weekly record from enrollment to 26 weeks (end of the trial).
Participants masking feasibility
At the primary endpoint, participants will be asked to guess the treatment allocation to evaluate participant masking feasibility.
Measured: At 8 weeks
Patient acceptability
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.
Measured: At 8 weeks
Range of motion
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.
Measured: From enrollment to 4 weeks, 8 weeks and 6 months
Strength
The investigators will measure shoulder elevation in the scapular plane and external rotation strength using a handheld dynamometer.
Measured: From enrollment to 4 weeks, 8 weeks and 6 months
Timed Functional Arm and Shoulder Test (TFAST)
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.
Measured: From enrollment to 4 weeks, 8 weeks and 6 months
Supraspinatus and infraspinatus muscle cross-sectional area
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.
Measured: From enrollment to 4 weeks, 8 weeks and 6 months
Supraspinatus tendon morphology
The investigators will use ultrasound to take pictures of the supraspinatus tendons. Established ultrasound procedures will be used to measure supraspinatus tendon thickness.
Measured: From enrollment to 4 weeks, 8 weeks and 6 months
Supraspinatus tendon elastography
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.
Measured: From enrollment to 4 weeks, 8 weeks and 6 months
Pennsylvania Shoulder Score (PENN)
The PENN is a valid and reliable self-reported questionnaire for patients with shoulder pain.
Measured: From enrollment to 4 weeks, 8 weeks and 6 months
Global rating of change (GROC)
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).
Measured: At 4 weeks, 8 weeks and 6 months
Patient specific functional scale (PSFS)
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.
Measured: From enrollment to 4 weeks, 8 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start13 May 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873113
- Sponsor's protocol ID
- IRB202302184
- Other IDs
- R21AR082588-01A1
- Status last verified
- May 2025
- First submitted
- 3 Mar 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training for Subacromial Pain: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06873113
- Acronym / sponsor ID
- IRB202302184
- Conditions
- Shoulder Pain
- Keywords
- blood flow restriction training, BFRT, BFR, exercise, subacromial pain, rotator cuff tendinopathy, subacromial impingement, rotator cuff related shoulder pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 13 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active BFRT | Experimental | Device: Active BFRT, Behavioral: Strengthening Exercises with BFRT, Behavioral: Skilled Physical Therapy Care |
| Sham BFRT | Sham comparator | Device: Sham BFRT, Behavioral: Strengthening Exercises with BFRT, Behavioral: Skilled Physical Therapy Care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active BFRTThe 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 | Active BFRT |
| Sham BFRTThe 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. | Device | Sham BFRT |
| Strengthening Exercises with BFRTParticipants 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. | Behavioural | Active BFRT, Sham BFRT |
| Skilled Physical Therapy CareParticipants 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). | Behavioural | Active BFRT, Sham BFRT |
Primary outcome
Recruitment
Time frame: 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.
Intervention feasibility
Time frame: 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.
13 secondary outcomes
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
Patient specific functional scale (PSFS)
Time frame: From enrollment to 4 weeks, 8 weeks and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Yes
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Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active BFRT, Strengthening Exercises with BFRT and Skilled Physical Therapy Care in people with Shoulder Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Pozzi, PT, MA, PhD ((352) 273-6957, fpozzi@phhp.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Monthly report from beginning to completion of recruitment (anticipated 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.