Shoulder InjuryBFRNCT06223373
Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients
A study testing Blood Flow Restriction in people with Shoulder Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Shoulder Injury
- What is being tested?
- Blood Flow Restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2024to 18 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- injured patient with clinical and magnetic resonance imaging (MRI) consistent with a formal diagnosis of non-operative rotator cuff and/or biceps tendinopathy
- no prior upper extremity ipsilateral procedures or history of deep vein thrombosis
- those willing to be part of the study
Who cannot join
- patients younger than 18 or older than 55 years of age
- a history of revision surgery or prior ipsilateral upper extremity surgery
- concomitant ligamentous, tendinous, or cartilage injury that would alter postoperative rehabilitation protocol
- inability to comply with the proposed follow-up clinic visits
- patients lacking decisional capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients: Assessment of Efficacy in Return to Activity
Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.
Read the detailed description
Blood flow restriction (BFR) therapy is one such therapeutic tool that has received increasing attention, which involves application of a pressurized tourniquet to the injured limb during rehabilitation that limits atrophy when performing strength training with weight that otherwise would not produce enough of a contraction to prevent muscular atrophy. To date, several studies have been performed on BFR therapy, however, the effect of therapy on ligamentous and tendinous injury in the upper extremity remain unclear as most studies have focused on muscular strengthening in healthy individuals and on lower extremity injuries distal to the tourniquet.
- Conditions
- Shoulder Injury
- Being tested
- Blood Flow Restriction, "sham" Blood Flow Restriction
- Keywords
- Upper extremity injuries, muscle atrophy, tendinopathy
- Medical subject headings
- Shoulder Injuries, Muscular Atrophy, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionDevice
Also called BFR
In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.
"sham" Blood Flow RestrictionDevice
In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction (BFR) | Experimental | Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol Receives: Device: Blood Flow Restriction |
| "sham" Blood Flow Restriction (BFR) | Sham comparator | rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol Receives: Device: "sham" Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second)
measuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine - Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Baseline
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second)
measuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine - Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Week 6
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Baseline
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Week 6
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Baseline
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Week 6
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Baseline
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Week 6
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Baseline
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Week 6
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Baseline
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second)
Low Score indicates low torque/strength, high score indicates high torque/strength
Measured: Week 6
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Measured: Baseline
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Measured: Week 3
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Measured: Week 6
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Measured: Baseline
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Measured: Week 3
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Measured: Week 6
Visual Analog Scale (VAS) for PAIN - Baseline Scores
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity:
0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Measured: Baseline
Visual Analog Scale (VAS) for PAIN - Week 6 Scores
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity:
0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Measured: Week 6
Visual Analog Scale (VAS) for PAIN - Month 6 Scores
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity:
0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Measured: Month 6
Visual Analog Scale (VAS) for PAIN - Month 12 Scores
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity:
0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Measured: Month 12
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Baseline Scores
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Measured: Baseline
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Week 6 Scores
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Measured: Week 6
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Month 6 Scores
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Measured: Month 6
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Month 12 Scores
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Measured: Month 12
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Baseline Scores
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Measured: Baseline
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Week 6 Scores
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Measured: Week 6
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Month 6 Scores
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Measured: Month 6
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Month 12 Scores
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Measured: Month 12
GH Levels - Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Measured: Baseline
GH Levels - Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Measured: Week 3
GH Levels - Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Measured: Week 6
IGF-1 Levels - Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Measured: Baseline
IGF-1 Levels - Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Measured: Week 3
IGF-1 Levels - Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Measured: Week 6
IL-6 Levels - Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Measured: Baseline
IL-6 Levels - Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Measured: Week 3
IL-6 Levels - Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start13 Apr 2024
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Why it stopped: unable to finish the study prior to graduation from residency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder InjuryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients who will be recruited into randomized into 1 of 2 study arms: 1) those undergoing rehabilitation using Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol or 2) those undergoing rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen Nicholson, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223373
- Sponsor's protocol ID
- IRB00103746
- Acronym
- BFR
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2024
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients: Assessment of Efficacy in Return to Activity
- ClinicalTrials.gov ID
- NCT06223373
- Acronym / sponsor ID
- BFR / IRB00103746
- Conditions
- Shoulder Injury
- Keywords
- Upper extremity injuries, muscle atrophy, tendinopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to finish the study prior to graduation from residency
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 13 Apr 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Posted 4 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.
Detailed description
Blood flow restriction (BFR) therapy is one such therapeutic tool that has received increasing attention, which involves application of a pressurized tourniquet to the injured limb during rehabilitation that limits atrophy when performing strength training with weight that otherwise would not produce enough of a contraction to prevent muscular atrophy. To date, several studies have been performed on BFR therapy, however, the effect of therapy on ligamentous and tendinous injury in the upper extremity remain unclear as most studies have focused on muscular strengthening in healthy individuals and on lower extremity injuries distal to the tourniquet.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients who will be recruited into randomized into 1 of 2 study arms: 1) those undergoing rehabilitation using Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol or 2) those undergoing rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol.
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction (BFR) | Experimental | Device: Blood Flow RestrictionBlood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol |
| "sham" Blood Flow Restriction (BFR) | Sham comparator | Device: "sham" Blood Flow Restrictionrehabilitation using "sham BFR" as well as our institutional rehabilitation protocol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- injured patient with clinical and magnetic resonance imaging (MRI) consistent with a formal diagnosis of non-operative rotator cuff and/or biceps tendinopathy
- no prior upper extremity ipsilateral procedures or history of deep vein thrombosis
- those willing to be part of the study
Key exclusion criteria (5 listed)
- patients younger than 18 or older than 55 years of age
- a history of revision surgery or prior ipsilateral upper extremity surgery
- concomitant ligamentous, tendinous, or cartilage injury that would alter postoperative rehabilitation protocol
- inability to comply with the proposed follow-up clinic visits
- patients lacking decisional capacity
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 |
|---|---|---|
| Blood Flow RestrictionAlso: BFRIn the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity. | Device | Blood Flow Restriction (BFR) |
| "sham" Blood Flow RestrictionIn the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place. | Device | "sham" Blood Flow Restriction (BFR) |
Primary outcome
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second)
Time frame: Baseline
measuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine - Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second)
Time frame: Week 6
measuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine - Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second)
Time frame: Baseline
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second)
Time frame: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second)
Time frame: Baseline
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second)
Time frame: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second)
Time frame: Baseline
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second)
Time frame: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second)
Time frame: Baseline
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second)
Time frame: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second)
Time frame: Baseline
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second)
Time frame: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
Time frame: Baseline
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
Time frame: Week 3
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
Time frame: Week 6
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
Time frame: Baseline
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
Time frame: Week 3
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
Time frame: Week 6
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Visual Analog Scale (VAS) for PAIN - Baseline Scores
Time frame: Baseline
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Visual Analog Scale (VAS) for PAIN - Week 6 Scores
Time frame: Week 6
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Visual Analog Scale (VAS) for PAIN - Month 6 Scores
Time frame: Month 6
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Visual Analog Scale (VAS) for PAIN - Month 12 Scores
Time frame: Month 12
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Baseline Scores
Time frame: Baseline
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Week 6 Scores
Time frame: Week 6
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Month 6 Scores
Time frame: Month 6
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Month 12 Scores
Time frame: Month 12
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Baseline Scores
Time frame: Baseline
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Week 6 Scores
Time frame: Week 6
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Month 6 Scores
Time frame: Month 6
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Month 12 Scores
Time frame: Month 12
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
GH Levels - Baseline
Time frame: Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
GH Levels - Week 3
Time frame: Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
GH Levels - Week 6
Time frame: Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 Levels - Baseline
Time frame: Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 Levels - Week 3
Time frame: Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 Levels - Week 6
Time frame: Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IL-6 Levels - Baseline
Time frame: Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IL-6 Levels - Week 3
Time frame: Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IL-6 Levels - Week 6
Time frame: Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kristen Nicholson, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction in people with Shoulder Injury, run by Wake Forest University Health Sciences 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Nov 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?
Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second) (time frame: Baseline). The study lists 39 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 4 Nov 2025.