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: Recruiting
• 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 (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward Beck, MD; Phone Number: 630.9678844; Email: ecbeck@wakehealth.edu
• Study Contact Backup: Name: Kristen Nicholson, MD; Phone Number: 336.716.3950; Email: kfnichol@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Eward Beck, MD; Phone Number: 630-967-8844; Email: ecbeck@wakehealth.edu
      • Principal Investigator: Kristen Nicholson, MD

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
Change in Shoulder muscle strength	measuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine.	Week 6
Change in cross sectional area (CSA)	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
functional Shoulder scores - Return to Sport up to Month 12	Patients will receive questionnaires evaluating shoulder function at baseline, once cleared to return to sport, as well as 6 and 12 months after completing rehabilitation	Return to Sport up to Month 12
functional Shoulder scores - Baseline	Patients will receive questionnaires evaluating shoulder function at baseline, once cleared to return to sport, as well as 6 and 12 months after completing rehabilitation	Baseline
functional Shoulder scores - Month 6	Patients will receive questionnaires evaluating shoulder function at baseline, once cleared to return to sport, as well as 6 and 12 months after completing rehabilitation	Month 6
functional Shoulder scores - Month 12	Patients will receive questionnaires evaluating shoulder function at baseline, once cleared to return to sport, as well as 6 and 12 months after completing rehabilitation	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 - Day 1	Patients will receive the blood draws in the physical therapy clinic -ELISA will be used to quantify plasma levels	Day 1
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
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 - Day 1	Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels	Day 1
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
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 - Day 1	Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels	Day 1
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

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 (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

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 (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: tendinopathy; muscle atrophy; Upper extremity injuries
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries
• 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