Shoulder Injury
Conditions
Keywords
Upper extremity injuries, muscle atrophy, tendinopathy
Brief 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.
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.
Interventions
DEVICEBlood Flow Restriction
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.
In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second) | 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 (180 Degrees/Second) | 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) | 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) | 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) | 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) | Baseline | Low Score indicates low torque/strength, high score indicates high torque/strength |
| Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus | 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 | 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. |
| Visual Analog Scale (VAS) for PAIN - Baseline Scores | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline | Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels |
| GH Levels - Week 3 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Week 6 | Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blood Flow Restriction (BFR) Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol
Blood Flow Restriction: 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. | 1 |
| Sham Blood Flow Restriction (BFR) rehabilitation using sham BFR as well as our institutional rehabilitation protocol
sham Blood Flow Restriction: In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place. | 2 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Sham Blood Flow Restriction (BFR) | Total | Blood Flow Restriction (BFR) |
|---|---|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 10.6 | 42.3 years STANDARD_DEVIATION 7.6 | 44 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Baseline Scores | 73 score on a scale | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Baseline Scores | 42.5 score on a scale | Standard Deviation 6.6 |
Primary
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
Time frame: Month 12
Population: Patient lost to follow up, value never collected -Patient lost to follow up, value never collected
Primary
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
Time frame: Month 6
Population: 2 Sham patients lost to follow up and measure was never reported or collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Month 6 Scores | 100 score on a scale | Standard Deviation 0 |
Primary
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
Time frame: Week 6
Population: Patient elected to do PT at home and was lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Week 6 Scores | 95 score on a scale | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Week 6 Scores | 42 score on a scale | Standard Deviation 0 |
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Baseline Scores | 35.5 score on a scale | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Baseline Scores | 62.6 score on a scale | Standard Deviation 27.4 |
Primary
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
Time frame: Month 12
Population: Patient lost to follow up, value never collected - Patient lost to follow up, value never collected
Primary
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
Time frame: Month 6
Population: 2 Sham patients lost to follow up and measure was never reported or collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Month 6 Scores | 0 score on a scale | Standard Deviation 0 |
Primary
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
Time frame: Week 6
Population: Patient elected to do PT at home and was lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Week 6 Scores | 0 score on a scale | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Week 6 Scores | 68.4 score on a scale | Standard Deviation 0 |
Primary
GH Levels - Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Time frame: Baseline
Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Primary
GH Levels - Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Time frame: Week 3
Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Primary
GH Levels - Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Time frame: Week 6
Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Primary
IGF-1 Levels - Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Time frame: Baseline
Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Primary
IGF-1 Levels - Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Time frame: Week 3
Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Primary
IGF-1 Levels - Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Time frame: Week 6
Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Primary
IL-6 Levels - Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Time frame: Baseline
Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Primary
IL-6 Levels - Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Time frame: Week 3
Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Primary
IL-6 Levels - Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
Time frame: Week 6
Population: The lab test required to run these data is a 96+ well plate that costs nearly $1000+. Our department could not financially justify buying this test to analyze 3 data points that would not provide reliable data for publication. Therefore, this test was never performed or analyzed.
Primary
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.
Time frame: Week 6
Population: Patient elected to do PT at home and was lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus | 12.33 cm2 | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus | 11.76 cm2 | Standard Deviation 0 |
Primary
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.
Time frame: Week 3
Population: Patient elected to do PT at home and was lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus | 11.89 cm2 | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus | 11.24 cm2 | Standard Deviation 0 |
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus | 11.84 cm2 | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus | 11.48 cm2 | Standard Deviation 0.24 |
Primary
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.
Time frame: Week 6
Population: Patient elected to do PT at home and was lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus | 10.34 cm2 | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus | 6.48 cm2 | Standard Deviation 0 |
Primary
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.
Time frame: Week 3
Population: Patient elected to do PT at home and was lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus | 10.15 cm2 | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus | 6.33 cm2 | Standard Deviation 0 |
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus | 10.04 cm2 | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus | 7.29 cm2 | Standard Deviation 1.23 |
Primary
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
Time frame: Week 6
Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second) | 16.6 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second) | 13.9 ft-lb (pound foot) | Standard Deviation 0 |
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second) | 19.0 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second) | 11.1 ft-lb (pound foot) | Standard Deviation 5.9 |
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second) | 14.4 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second) | 7.0 ft-lb (pound foot) | Standard Deviation 0.28 |
Primary
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
Time frame: Week 6
Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second) | 11.2 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second) | 13.6 ft-lb (pound foot) | Standard Deviation 0 |
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second) | 28.6 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second) | 13.1 ft-lb (pound foot) | Standard Deviation 8.3 |
Primary
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
Time frame: Week 6
Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second) | 23.2 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second) | 19.2 ft-lb (pound foot) | Standard Deviation 0 |
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second) | 23.5 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second) | 15.6 ft-lb (pound foot) | Standard Deviation 7.8 |
Primary
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
Time frame: Week 6
Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second) | 26.7 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second) | 7.6 ft-lb (pound foot) | Standard Deviation 0 |
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second) | 23.5 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second) | 14.5 ft-lb (pound foot) | Standard Deviation 2.3 |
Primary
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
Time frame: Week 6
Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second) | 26.6 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second) | 6.6 ft-lb (pound foot) | Standard Deviation 0 |
Primary
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
Time frame: Week 6
Population: Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second) | 27.2 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second) | 9.9 ft-lb (pound foot) | Standard Deviation 0 |
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second) | 23.2 ft-lb (pound foot) | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second) | 11.0 ft-lb (pound foot) | Standard Deviation 9.5 |
Primary
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.
Time frame: Baseline
Population: 1 patient did not have any data collected at this field
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Visual Analog Scale (VAS) for PAIN - Baseline Scores | 3 score on a scale | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Visual Analog Scale (VAS) for PAIN - Baseline Scores | 5 score on a scale | Standard Deviation 0 |
Primary
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.
Time frame: Month 12
Population: All patients lost to follow up, value never collected
Primary
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.
Time frame: Month 6
Population: 1 patient elected to do PT at home and 1 patient had surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Visual Analog Scale (VAS) for PAIN - Month 6 Scores | 0 Score on a scale | Standard Deviation 0 |
Primary
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.
Time frame: Week 6
Population: Patient elected to do PT at home and was lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Visual Analog Scale (VAS) for PAIN - Week 6 Scores | 0 score on a scale | Standard Deviation 0 |
| Sham Blood Flow Restriction (BFR) | Visual Analog Scale (VAS) for PAIN - Week 6 Scores | 4 score on a scale | Standard Deviation 0 |