Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients (BFR)

Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients: Assessment of Efficacy in Return to Activity

Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.

Study Overview

• Status: Terminated
• Conditions: Shoulder Injury
• Intervention / Treatment: Device: Blood Flow Restriction; Device: "sham" Blood Flow Restriction

Detailed Description

Blood flow restriction (BFR) therapy is one such therapeutic tool that has received increasing attention, which involves application of a pressurized tourniquet to the injured limb during rehabilitation that limits atrophy when performing strength training with weight that otherwise would not produce enough of a contraction to prevent muscular atrophy. To date, several studies have been performed on BFR therapy, however, the effect of therapy on ligamentous and tendinous injury in the upper extremity remain unclear as most studies have focused on muscular strengthening in healthy individuals and on lower extremity injuries distal to the tourniquet.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Flow Restriction (BFR); Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol	Device: 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.; Other Names: BFR
Sham Comparator: "sham" Blood Flow Restriction (BFR); rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol	Device: "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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Kristen Nicholson, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2024
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: tendinopathy; muscle atrophy; Upper extremity injuries
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Wounds and Injuries; Pathological Conditions, Anatomical; Tendon Injuries; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Injuries; Muscular Atrophy; Tendinopathy; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: IRB00103746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes