Return to Baseball After BFR Therapy for Shoulder Injury

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Musculoskeletal Injury

Treatments: Device: Blood Flow Restriction Therapy; Other: Standard physical rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04248413

IRB00062859

Details and patient eligibility

About

The literature is limited on whether BFR therapy provides improved return to function after acute rotator cuff or biceps rehabilitation in non-operative cases, and whether there is a clear mechanism of action in musculotendinous repair after BFR therapy. The purpose of the study is to 1) evaluate patient reported outcomes and return to play in baseball athletes undergoing rehabilitation with blood flow restriction (BFR) therapy for shoulder injury and 2) evaluate changes in blood biomarkers to assess the mechanism of action of BFR therapy in injured athletes. Investigators will perform a randomized blinded placebo-controlled trial of 2 separate study populations: 1) baseball players with biceps or rotator cuff tendinopathy undergoing non-operative treatment with BFR therapy incorporated into routine physical rehabilitation and 2) baseball players with biceps or rotator cuff tendinopathy undergoing non-operative treatment with routine physical rehabilitation alone.

Primary outcomes will be functional outcomes and evaluation of return to sport. Functional outcomes will be evaluated using validated patient reported outcome surveys that are upper extremity-specific. Return to sport will be assessed by evaluating time to receiving clearance for returning to routine practices and reported level of physical performance and re-injury. Secondary outcomes will be measurement in muscle strength and blood biomarkers, as well as evaluation of 3D throwing motion. Strength will be measured using a biodex system at baseline prior to beginning physical rehabilitation, half-way through the rehabilitation protocol +/- BFR phase, and once cleared for return to play. Blood biomarkers GH, IGF-I, and IL-6 will be quantified at the same time points in order to investigate the mechanism of action of BFR on tissue repair. Patients will be followed longitudinally during this time for rates of reinjury.

Full description

This study will evaluate the efficacy of BFR therapy in physical rehabilitation for baseball athletes with non-operative biceps or rotator cuff tendinopathy. This will be directly measured by evaluation of upper extremity biomechanics measurements, strength testing, patient reported functional outcome scores, and identifying time required for clearance of return to sport. These outcomes in patients undergoing BFR therapy in addition to traditional rehabilitation will be compared to patients undergoing traditional rehabilitation only.

Sex: All

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• any injured baseball athletes ages 14 to 25 years with clinical and radiographic examination (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

Exclusion criteria

• patients younger than 14 or older than 25 years of age
• non-native English speakers
• 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Standard rehabilitation protocol

Other group

Description:

Patients with non-operative rotator cuff and biceps tendinopathy assigned to this study arm will undergo the standardized physical rehabilitation protocol at our institution.

Treatment:

Other: Standard physical rehabilitation

Standard rehabilitation plus Blood Flow Restriction Therapy

Experimental group

Description:

Patients with non-operative rotator cuff and biceps tendinopathy assigned to this study arm will undergo the standardized physical rehabilitation protocol at our institution in addition to the BFR therapy. Per recommendations of Owens Recovery Science, the organization responsible for certifying physical therapists in BFR therapy, the therapy will take place concurrently throughout the duration of the rehabilitation.

Treatment:

Other: Standard physical rehabilitation

Device: Blood Flow Restriction Therapy