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Return to Baseball After BFR Therapy for Shoulder Injury

Primary Purpose

Musculoskeletal Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood Flow Restriction Therapy
Standard physical rehabilitation
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Injury focused on measuring Shoulder injury, Baseball injury, Muscle strength

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Standard rehabilitation protocol

    Standard rehabilitation plus Blood Flow Restriction Therapy

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    3D throwing motion analysis
    Throwing biomechanics will be evaluated using 3D motion analysis.
    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.
    Human Growth Hormone (GH)
    GH will be quantified from blood draws and compared between the two study groups.
    Human Growth Hormone (GH)
    GH will be quantified from blood draws and compared between the two study groups.
    Human Growth Hormone (GH)
    GH will be quantified from blood draws and compared between the two study groups.
    Interleukin 6 (IL-6)
    IL-6 will be quantified from blood draws and compared between the two study groups.
    Interleukin 6 (IL-6)
    IL-6 will be quantified from blood draws and compared between the two study groups.
    Interleukin 6 (IL-6)
    IL-6 will be quantified from blood draws and compared between the two study groups.
    Insulin-Like Growth Factor (IGF)
    IGF will be quantified from blood draws and compared between the two study groups.
    Insulin-Like Growth Factor (IGF)
    IGF will be quantified from blood draws and compared between the two study groups.
    Insulin-Like Growth Factor (IGF)
    IGF will be quantified from blood draws and compared between the two study groups.

    Full Information

    First Posted
    January 27, 2020
    Last Updated
    May 11, 2022
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04248413
    Brief Title
    Return to Baseball After BFR Therapy for Shoulder Injury
    Official Title
    Blood Flow Restriction Training Following Acute Shoulder Injury In Baseball Players: Assessment of Efficacy in Return to Sport
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Too many obstacles starting study
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Musculoskeletal Injury
    Keywords
    Shoulder injury, Baseball injury, Muscle strength

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard rehabilitation protocol
    Arm Type
    Other
    Arm 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.
    Arm Title
    Standard rehabilitation plus Blood Flow Restriction Therapy
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Blood Flow Restriction Therapy
    Intervention Description
    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
    Other
    Intervention Name(s)
    Standard physical rehabilitation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    American Shoulder and Elbow Surgeons (ASES) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.
    Time Frame
    Questionnaire assigned at baseline prior to the rehabilitation protocol.
    Title
    American Shoulder and Elbow Surgeons (ASES) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.
    Time Frame
    Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
    Title
    American Shoulder and Elbow Surgeons (ASES) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.
    Time Frame
    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.
    Title
    American Shoulder and Elbow Surgeons (ASES) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.
    Time Frame
    Questionnaire assigned 6-months after completing the rehabilitation protocol.
    Title
    American Shoulder and Elbow Surgeons (ASES) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.
    Time Frame
    Questionnaire assigned 12-months after completing the rehabilitation protocol.
    Title
    Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.
    Time Frame
    Questionnaire assigned at baseline prior to the rehabilitation protocol.
    Title
    Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.
    Time Frame
    Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
    Title
    Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.
    Time Frame
    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.
    Title
    Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.
    Time Frame
    Questionnaire assigned 6-months after completing the rehabilitation protocol.
    Title
    Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
    Description
    Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.
    Time Frame
    Questionnaire assigned 12-months after completing the rehabilitation protocol.
    Title
    Return to sport questionnaire
    Description
    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.
    Time Frame
    Questionnaire assigned 6-months after completing the rehabilitation protocol.
    Title
    Return to sport questionnaire
    Description
    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.
    Time Frame
    Questionnaire assigned 12-months after completing the rehabilitation protocol.
    Secondary Outcome Measure Information:
    Title
    Muscle Strength
    Description
    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.
    Time Frame
    Measured at baseline prior to the rehabilitation protocol.
    Title
    Muscle Strength
    Description
    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.
    Time Frame
    Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
    Title
    Muscle Strength
    Description
    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.
    Time Frame
    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.
    Title
    3D throwing motion analysis
    Description
    Throwing biomechanics will be evaluated using 3D motion analysis.
    Time Frame
    Performed at baseline prior to the rehabilitation protocol.
    Title
    3D throwing motion analysis
    Description
    Throwing biomechanics will be evaluated using 3D motion analysis and will be compared to 3D throwing motion captured at baseline prior to beginning rehabilitation.
    Time Frame
    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.
    Title
    Human Growth Hormone (GH)
    Description
    GH will be quantified from blood draws and compared between the two study groups.
    Time Frame
    Measured at baseline prior to the rehabilitation protocol.
    Title
    Human Growth Hormone (GH)
    Description
    GH will be quantified from blood draws and compared between the two study groups.
    Time Frame
    Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
    Title
    Human Growth Hormone (GH)
    Description
    GH will be quantified from blood draws and compared between the two study groups.
    Time Frame
    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.
    Title
    Interleukin 6 (IL-6)
    Description
    IL-6 will be quantified from blood draws and compared between the two study groups.
    Time Frame
    Measured at baseline prior to the rehabilitation protocol.
    Title
    Interleukin 6 (IL-6)
    Description
    IL-6 will be quantified from blood draws and compared between the two study groups.
    Time Frame
    Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
    Title
    Interleukin 6 (IL-6)
    Description
    IL-6 will be quantified from blood draws and compared between the two study groups.
    Time Frame
    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.
    Title
    Insulin-Like Growth Factor (IGF)
    Description
    IGF will be quantified from blood draws and compared between the two study groups.
    Time Frame
    Measured at baseline prior to the rehabilitation protocol.
    Title
    Insulin-Like Growth Factor (IGF)
    Description
    IGF will be quantified from blood draws and compared between the two study groups.
    Time Frame
    Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
    Title
    Insulin-Like Growth Factor (IGF)
    Description
    IGF will be quantified from blood draws and compared between the two study groups.
    Time Frame
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristen F Nicholson, PhD
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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