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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
3
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.
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
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
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
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
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
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
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
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Low Score indicates low torque/strength, high score indicates high torque/strength
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 12
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
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
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
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
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
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
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
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
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