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

Wake Forest University (WFU)

Status: Terminated

Conditions: Shoulder Injury

Treatments: Device: "sham" Blood Flow Restriction; Device: Blood Flow Restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT06223373

IRB00103746

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Blood Flow Restriction (BFR)

Experimental group

Description:

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

Treatment:

Device: Blood Flow Restriction

"sham" Blood Flow Restriction (BFR)

Sham Comparator group

Description:

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

Treatment:

Device: "sham" Blood Flow Restriction