Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients

NCT06223373 | Terminated Results FDA Device

• 1 other identifier: IRB00103746
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Injury

Keywords

Upper extremity injuries; muscle atrophy; tendinopathy

Outcome Measures

Primary Outcomes (39)

• 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

Study Arms (2)

Blood Flow Restriction (BFR)

EXPERIMENTAL

Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol

Device: Blood Flow Restriction

"sham" Blood Flow Restriction (BFR)

SHAM COMPARATOR

rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol

Device: "sham" Blood Flow Restriction

Interventions

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.

Also known as: BFR

Blood Flow Restriction (BFR)

"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.

"sham" Blood Flow Restriction (BFR)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Shoulder Injuries; Muscular Atrophy; Tendinopathy

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Kristen Faith Nicholson, PhD
• Organization: Wake Forest University Health Sciences

Kristen.Nicholson@advocatehealth.org

704-355-2000

Study Officials

• Kristen Nicholson, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: April 13, 2024
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)