Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients
- Conditions
- Shoulder Injury
- Interventions
- Device: Blood Flow RestrictionDevice: "sham" Blood Flow Restriction
- Registration Number
- NCT06223373
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blood Flow Restriction (BFR) Blood Flow Restriction Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol "sham" Blood Flow Restriction (BFR) "sham" Blood Flow Restriction rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol
- Primary Outcome Measures
Name Time Method GH levels - Day 1 Day 1 Patients will receive the blood draws in the physical therapy clinic -ELISA will be used to quantify plasma levels
Change in Shoulder muscle strength Week 6 measuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine.
Change in cross sectional area (CSA) Week 6 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.
IL-6 levels - Day 1 Day 1 Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
functional Shoulder scores - Baseline 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
functional Shoulder scores - Month 12 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
GH levels - Baseline Baseline Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 levels - Baseline Baseline Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 levels - Week 3 Week 3 Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 levels - Week 6 Week 6 Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
functional Shoulder scores - Return to Sport up to Month 12 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
functional Shoulder scores - Month 6 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
GH levels - Week 3 Week 3 Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IL-6 levels - Week 6 Week 6 Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
GH levels - Week 6 Week 6 Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IL-6 levels - Baseline Baseline Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IL-6 levels - Week 3 Week 3 Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 levels - Day 1 Day 1 Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States