Return to Baseball After BFR Therapy for Shoulder Injury

Not Applicable

Withdrawn

• Conditions: Musculoskeletal Injury
• Interventions: Device: Blood Flow Restriction Therapy; Other: Standard physical rehabilitation

• Registration Number: NCT04248413
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Status Verified: 2022-05
• Study Start: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-16
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard rehabilitation plus Blood Flow Restriction Therapy	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.
Standard rehabilitation plus Blood Flow Restriction Therapy	Standard physical rehabilitation	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.
Standard rehabilitation protocol	Standard physical rehabilitation	Patients with non-operative rotator cuff and biceps tendinopathy assigned to this study arm will undergo the standardized physical rehabilitation protocol at our institution.

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	Questionnaire assigned 12-months after completing the rehabilitation protocol.	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.
American Shoulder and Elbow Surgeons (ASES) questionnaire	Questionnaire assigned 12-months after completing the rehabilitation protocol.	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.
Return to sport questionnaire	Questionnaire assigned 12-months after completing the rehabilitation protocol.	Patient-reported questionnaire evaluating physical performance and re-injury after undergoing rehabilitation. Patient-reported outcome questionnaire with a score ranging from 0 to 10. A higher score denotes a better outcome.

Secondary Outcome Measures

Name	Time	Method
Human Growth Hormone (GH)	Measured at the end of the rehabilitation protocol, corresponding to when the patient is cleared to return to sport, which is approximately 12-14 weeks from start of rehabilitation.	GH will be quantified from blood draws and compared between the two study groups.
Insulin-Like Growth Factor (IGF)	Measured at the end of the rehabilitation protocol, corresponding to when the patient is cleared to return to sport, which is approximately 12-14 weeks from start of rehabilitation.	IGF will be quantified from blood draws and compared between the two study groups.
Muscle Strength	Measured at the end of the rehabilitation protocol, corresponding to when the patient is cleared to return to sport, which is approximately 12-14 weeks from start of rehabilitation.	Upper extremity muscle strength will be measured using a biodex strength training machine. Physiological parameters will include peak torque (measured as Newtons) and time to peak torque (measured in seconds), which is time from the start of the muscular contraction to the point of highest torque.
3D throwing motion analysis	Performed at the end of the rehabilitation protocol, corresponding to when the patient is cleared to return to sport, which is approximately 12-14 weeks from start of rehabilitation.	Throwing biomechanics will be evaluated using 3D motion analysis and will be compared to 3D throwing motion captured at baseline prior to beginning rehabilitation.
Interleukin 6 (IL-6)	Measured at the end of the rehabilitation protocol, corresponding to when the patient is cleared to return to sport, which is approximately 12-14 weeks from start of rehabilitation.	IL-6 will be quantified from blood draws and compared between the two study groups.