Return to Baseball After BFR Therapy for Shoulder Injury

NCT ID: NCT04248413

Last Updated: 2022-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Musculoskeletal Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The PI who will be performing the analysis will be blinded to patients who underwent routine physical rehabilitation vs those who underwent routine rehabilitation plus blood flow restriction therapy.

Study Groups

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Standard rehabilitation protocol

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

Group Type OTHER

Standard physical rehabilitation

Intervention Type OTHER

Patients diagnosed with non-operative rotator cuff or biceps tendinopathy will undergo physical rehabilitation under the supervision of the same physical therapists who will be performing the BFR therapy.

Standard rehabilitation plus Blood Flow Restriction Therapy

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.

Group Type EXPERIMENTAL

Blood Flow Restriction Therapy

Intervention Type DEVICE

The blood flow restriction cuff, which is regulated by the FDA under 878.5910 and is registered under number 9681444, is manufactured by Delfi Medical. The cuff will be used as recommended by the manufacturer and Owens Recovery Science, the company who provides certificating of blood flow restriction training.

Standard physical rehabilitation

Intervention Type OTHER

Patients diagnosed with non-operative rotator cuff or biceps tendinopathy will undergo physical rehabilitation under the supervision of the same physical therapists who will be performing the BFR therapy.

Interventions

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Blood Flow Restriction Therapy

The blood flow restriction cuff, which is regulated by the FDA under 878.5910 and is registered under number 9681444, is manufactured by Delfi Medical. The cuff will be used as recommended by the manufacturer and Owens Recovery Science, the company who provides certificating of blood flow restriction training.

Intervention Type DEVICE

Standard physical rehabilitation

Patients diagnosed with non-operative rotator cuff or biceps tendinopathy will undergo physical rehabilitation under the supervision of the same physical therapists who will be performing the BFR therapy.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristen F Nicholson, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

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Other Identifiers

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IRB00062859

Identifier Type: -

Identifier Source: org_study_id

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