Return to Baseball After BFR Therapy for Shoulder Injury

Blood Flow Restriction Training Following Acute Shoulder Injury In Baseball Players: Assessment of Efficacy in Return to Sport

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.

Study Overview

• Status: Withdrawn
• Conditions: Musculoskeletal Injury
• Intervention / Treatment: Other: Standard physical rehabilitation; Device: Blood Flow Restriction Therapy

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Other: 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.
EXPERIMENTAL: 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.	Other: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons (ASES) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.	Questionnaire assigned at baseline prior to the rehabilitation protocol.
American Shoulder and Elbow Surgeons (ASES) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.	Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
American Shoulder and Elbow Surgeons (ASES) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.	Questionnaire assigned 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.
American Shoulder and Elbow Surgeons (ASES) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.	Questionnaire assigned 6-months after completing the rehabilitation protocol.
American Shoulder and Elbow Surgeons (ASES) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.	Questionnaire assigned 12-months after completing the rehabilitation protocol.
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.	Questionnaire assigned at baseline prior to the rehabilitation protocol.
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.	Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.	Questionnaire assigned 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.
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.	Questionnaire assigned 6-months after completing the rehabilitation protocol.
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.	Questionnaire assigned 12-months after completing the rehabilitation protocol.
Return to sport questionnaire	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.	Questionnaire assigned 6-months after completing the rehabilitation protocol.
Return to sport questionnaire	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.	Questionnaire assigned 12-months after completing the rehabilitation protocol.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength	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.	Measured at baseline prior to the rehabilitation protocol.
Muscle Strength	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.	Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
Muscle Strength	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.	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.
3D throwing motion analysis	Throwing biomechanics will be evaluated using 3D motion analysis.	Performed at baseline prior to the rehabilitation protocol.
3D throwing motion analysis	Throwing biomechanics will be evaluated using 3D motion analysis and will be compared to 3D throwing motion captured at baseline prior to beginning rehabilitation.	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.
Human Growth Hormone (GH)	GH will be quantified from blood draws and compared between the two study groups.	Measured at baseline prior to the rehabilitation protocol.
Human Growth Hormone (GH)	GH will be quantified from blood draws and compared between the two study groups.	Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
Human Growth Hormone (GH)	GH will be quantified from blood draws and compared between the two study groups.	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.
Interleukin 6 (IL-6)	IL-6 will be quantified from blood draws and compared between the two study groups.	Measured at baseline prior to the rehabilitation protocol.
Interleukin 6 (IL-6)	IL-6 will be quantified from blood draws and compared between the two study groups.	Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
Interleukin 6 (IL-6)	IL-6 will be quantified from blood draws and compared between the two study groups.	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.
Insulin-Like Growth Factor (IGF)	IGF will be quantified from blood draws and compared between the two study groups.	Measured at baseline prior to the rehabilitation protocol.
Insulin-Like Growth Factor (IGF)	IGF will be quantified from blood draws and compared between the two study groups.	Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
Insulin-Like Growth Factor (IGF)	IGF will be quantified from blood draws and compared between the two study groups.	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.

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Kristen F Nicholson, PhD, Wake Forest University Health Sciences

Publications and helpful links

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Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Muscle strength; Shoulder injury; Baseball injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: IRB00062859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes