Musculoskeletal Injury
Conditions
Keywords
Shoulder injury, Baseball injury, Muscle strength
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.
Interventions
DEVICEBlood 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.
OTHERStandard 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes 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.
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) questionnaire | Questionnaire assigned at baseline prior to the rehabilitation protocol. | 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 | Questionnaire assigned at baseline prior to the rehabilitation protocol. | Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome. |
| Return to sport questionnaire | Questionnaire assigned 6-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
| Measure | Time frame | Description |
|---|---|---|
| Interleukin 6 (IL-6) | Measured at baseline prior to the rehabilitation protocol. | IL-6 will be quantified from blood draws and compared between the two study groups. |
| Muscle Strength | Measured at baseline prior to the rehabilitation protocol. | 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. |
| Insulin-Like Growth Factor (IGF) | Measured at baseline prior to the rehabilitation protocol. | IGF will be quantified from blood draws and compared between the two study groups. |
| 3D throwing motion analysis | Performed at baseline prior to the rehabilitation protocol. | Throwing biomechanics will be evaluated using 3D motion analysis. |
| Human Growth Hormone (GH) | Measured at baseline prior to the rehabilitation protocol. | GH will be quantified from blood draws and compared between the two study groups. |
Outcome results
None listed