Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients

Shoulder Injury Clinical Trial

— BFR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223373
• Other study ID #: IRB00103746
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2024
• Est. completion date: July 2026

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: Edward Beck, MD
• Phone: 630.9678844
• Email: ecbeck[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Injuries
• Shoulder Injury
• Wounds and Injuries

Intervention

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.
• "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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	GH levels - Baseline	Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels	Baseline
Primary	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
Primary	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
Primary	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
Primary	IL-6 levels - Baseline	Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels	Baseline
Primary	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
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	Week 3
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	Week 6
Primary	IGF-1 levels - Baseline	Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels	Baseline
Primary	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
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	Week 3
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	Week 6