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unable to finish the study prior to graduation from residency
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Flow Restriction (BFR) | Experimental | Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol |
|
| "sham" Blood Flow Restriction (BFR) | Sham Comparator | rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Nicholson, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | "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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Baseline |
|
Month 6
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Faith Nicholson, PhD | Wake Forest University Health Sciences | 704-355-2000 | Kristen.Nicholson@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2024 | Sep 12, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2024 | Aug 28, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| D009133 | Muscular Atrophy |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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.
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|
| "sham" Blood Flow Restriction | Device | In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place. |
|
| 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Month 12 |
| GH Levels - Baseline | Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels | Baseline |
| GH Levels - Week 3 | Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Week 6 |
| BG001 |
| "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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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. |
|
|
| 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 | Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up. | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Week 6 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Baseline |
|
|
|
| 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 | Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up. | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Week 6 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Baseline |
|
|
|
| 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 | Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up. | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Week 6 |
|
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| 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 | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Baseline |
|
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| 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 | Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up. | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Week 6 |
|
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| 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 | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Baseline |
|
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| 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 | Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up. | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Week 6 |
|
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| 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 | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Baseline |
|
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|
| 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 | Follow up measure was never performed or recorded for 1 sham patient due to loss of follow up. | Posted | Mean | Standard Deviation | ft-lb (pound foot) | Week 6 |
|
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|
| 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. | Posted | Median | Standard Deviation | cm2 | Baseline |
|
|
|
| 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. | Patient elected to do PT at home and was lost to follow up | Posted | Mean | Standard Deviation | cm2 | Week 3 |
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| 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. | Patient elected to do PT at home and was lost to follow up | Posted | Mean | Standard Deviation | cm2 | Week 6 |
|
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| 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. | Posted | Mean | Standard Deviation | cm2 | Baseline |
|
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| 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. | Patient elected to do PT at home and was lost to follow up | Posted | Mean | Standard Deviation | cm2 | Week 3 |
|
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| 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. | Patient elected to do PT at home and was lost to follow up | Posted | Mean | Standard Deviation | cm2 | Week 6 |
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| 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. | 1 patient did not have any data collected at this field | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | Patient elected to do PT at home and was lost to follow up | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
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| 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. | 1 patient elected to do PT at home and 1 patient had surgery | Posted | Mean | Standard Deviation | Score on a scale | Month 6 |
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| 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. | All patients lost to follow up, value never collected | Posted | Month 12 |
|
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| 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 | Patient elected to do PT at home and was lost to follow up | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
|
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| 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 | 2 Sham patients lost to follow up and measure was never reported or collected. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
|
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| 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 | Patient lost to follow up, value never collected -Patient lost to follow up, value never collected | Posted | Month 12 |
|
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| 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 | Patient elected to do PT at home and was lost to follow up | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
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| 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 | 2 Sham patients lost to follow up and measure was never reported or collected. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| 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 | Patient lost to follow up, value never collected - Patient lost to follow up, value never collected | Posted | Month 12 |
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| Primary | GH Levels - Baseline | Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels | 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. | Posted | Baseline |
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| Primary | GH Levels - Week 3 | Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels | 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. | Posted | Week 3 |
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| Primary | GH Levels - Week 6 | Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels | 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. | Posted | Week 6 |
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| Primary | IGF-1 Levels - Baseline | Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels | 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. | Posted | Baseline |
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| 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 | 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. | Posted | Week 3 |
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| 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 | 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. | Posted | Week 6 |
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| Primary | IL-6 Levels - Baseline | Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels | 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. | Posted | Baseline |
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| 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 | 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. | Posted | Week 3 |
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| 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 | 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. | Posted | Week 6 |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | "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. | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |