Clinical trial NCT04248413: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Musculoskeletal Injury
Keywords: Shoulder injury
Baseball injury
Muscle strength
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) questionnaire
timeFrame: Questionnaire assigned at baseline prior to the rehabilitation protocol.
measure: American Shoulder and Elbow Surgeons (ASES) questionnaire
timeFrame: Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
measure: American Shoulder and Elbow Surgeons (ASES) questionnaire
timeFrame: 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.
measure: American Shoulder and Elbow Surgeons (ASES) questionnaire
timeFrame: Questionnaire assigned 6-months after completing the rehabilitation protocol.
measure: American Shoulder and Elbow Surgeons (ASES) questionnaire
timeFrame: Questionnaire assigned 12-months after completing the rehabilitation protocol.
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: Questionnaire assigned at baseline prior to the rehabilitation protocol.
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: 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.
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: Questionnaire assigned 6-months after completing the rehabilitation protocol.
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: Questionnaire assigned 12-months after completing the rehabilitation protocol.
measure: Return to sport questionnaire
timeFrame: Questionnaire assigned 6-months after completing the rehabilitation protocol.
measure: Return to sport questionnaire
timeFrame: Questionnaire assigned 12-months after completing the rehabilitation protocol.
Secondary outcomes:
measure: Muscle Strength
timeFrame: Measured at baseline prior to the rehabilitation protocol.
measure: Muscle Strength
timeFrame: Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
measure: Muscle Strength
timeFrame: 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.
measure: 3D throwing motion analysis
timeFrame: Performed at baseline prior to the rehabilitation protocol.
measure: 3D throwing motion analysis
timeFrame: 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.
measure: Human Growth Hormone (GH)
timeFrame: Measured at baseline prior to the rehabilitation protocol.
measure: Human Growth Hormone (GH)
timeFrame: Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
measure: Human Growth Hormone (GH)
timeFrame: 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.
measure: Interleukin 6 (IL-6)
timeFrame: Measured at baseline prior to the rehabilitation protocol.
measure: Interleukin 6 (IL-6)
timeFrame: Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
measure: Interleukin 6 (IL-6)
timeFrame: 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.
measure: Insulin-Like Growth Factor (IGF)
timeFrame: Measured at baseline prior to the rehabilitation protocol.
measure: Insulin-Like Growth Factor (IGF)
timeFrame: Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
measure: Insulin-Like Growth Factor (IGF)
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kristen F Nicholson, PhD
role: PRINCIPAL_INVESTIGATOR
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