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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard rehabilitation protocol | Other | Patients with non-operative rotator cuff and biceps tendinopathy assigned to this study arm will undergo the standardized physical rehabilitation protocol at our institution. |
|
| Standard rehabilitation plus Blood Flow Restriction Therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Therapy | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen F Nicholson, PhD | Wake Forest University Health Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24149640 | Background | Abe T, Fujita S, Nakajima T, Sakamaki M, Ozaki H, Ogasawara R, Sugaya M, Kudo M, Kurano M, Yasuda T, Sato Y, Ohshima H, Mukai C, Ishii N. Effects of Low-Intensity Cycle Training with Restricted Leg Blood Flow on Thigh Muscle Volume and VO2MAX in Young Men. J Sports Sci Med. 2010 Sep 1;9(3):452-8. eCollection 2010. | |
| Background | Abe T, Yasuda T, Midorikawa T, et al. Skeletal muscle size and circulating IGF-1 are increased after two weeks of twice daily "KAATSU" resistance training. International Journal of KAATSU Training Research. 2005;1(1):6-12. | ||
| 27661420 |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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.
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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.
|
| Standard physical rehabilitation | Other | 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. |
|
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. |
| 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. |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |