Musculoskeletal InjuryNCT04248413
Return to Baseball After BFR Therapy for Shoulder Injury
A study testing Blood Flow Restriction Therapy and Standard physical rehabilitation in people with Musculoskeletal Injury, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Blood Flow Restriction Therapy and Standard physical rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Injury
- Being tested
- Blood Flow Restriction Therapy, Standard physical rehabilitation
- Keywords
- Shoulder injury, Baseball injury, Muscle strength
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TherapyDevice
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.
Standard physical rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard physical rehabilitation |
| 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. Receives: Device: Blood Flow Restriction Therapy; Other: Standard physical rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Questionnaire assigned 12-months after completing the rehabilitation protocol.
Secondary outcomes (14)
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: 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: 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: 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.
Measured: 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.
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study startMay 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Too many obstacles starting study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen F Nicholson, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248413
- Sponsor's protocol ID
- IRB00062859
- Status last verified
- May 2022
- First submitted
- 27 Jan 2020
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24149640Abe 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.
Blair JA, Eisenstein ED, Pierrie SN, Gordon W, Owens JG, Hsu JR. Lower Extremity Limb Salvage: Lessons Learned From 14 Years at War. J Orthop Trauma. 2016 Oct;30 Suppl 3:S11-S15. doi: 10.1097/BOT.0000000000000669.
PubMed 27661420Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Sports Health. 2019 Mar/Apr;11(2):149-156. doi: 10.1177/1941738118821929. Epub 2019 Jan 14.
PubMed 30638439Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
PubMed 12671624Cancio J, Rhee P. Blood Flow Restriction Therapy after Non-Operative Management of Distal Radius Fracture: A Randomized Controlled Pilot Study. Journal of Hand Therapy. 2018;31(1).
Clarsen B, Myklebust G, Bahr R. Development and validation of a new method for the registration of overuse injuries in sports injury epidemiology: the Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire. Br J Sports Med. 2013 May;47(8):495-502. doi: 10.1136/bjsports-2012-091524. Epub 2012 Oct 4.
PubMed 23038786Conte S, Camp CL, Dines JS. Injury Trends in Major League Baseball Over 18 Seasons: 1998-2015. Am J Orthop (Belle Mead NJ). 2016 Mar-Apr;45(3):116-23.
PubMed 26991562Credeur DP, Hollis BC, Welsch MA. Effects of handgrip training with venous restriction on brachial artery vasodilation. Med Sci Sports Exerc. 2010 Jul;42(7):1296-302. doi: 10.1249/MSS.0b013e3181ca7b06.
PubMed 20019641Cvetanovich GL, Gowd AK, Liu JN, Nwachukwu BU, Cabarcas BC, Cole BJ, Forsythe B, Romeo AA, Verma NN. Establishing clinically significant outcome after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2019 May;28(5):939-948. doi: 10.1016/j.jse.2018.10.013. Epub 2019 Jan 24.
PubMed 30685283Dahlgren LA, Mohammed HO, Nixon AJ. Temporal expression of growth factors and matrix molecules in healing tendon lesions. J Orthop Res. 2005 Jan;23(1):84-92. doi: 10.1016/j.orthres.2004.05.007.
PubMed 15607879Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.
PubMed 26446893Dines JS, Frank JB, Akerman M, Yocum LA. Glenohumeral internal rotation deficits in baseball players with ulnar collateral ligament insufficiency. Am J Sports Med. 2009 Mar;37(3):566-70. doi: 10.1177/0363546508326712. Epub 2008 Dec 4.
PubMed 19059890Erickson LN, Lucas KCH, Davis KA, Jacobs CA, Thompson KL, Hardy PA, Andersen AH, Fry CS, Noehren BW. Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial. Phys Ther. 2019 Aug 1;99(8):1010-1019. doi: 10.1093/ptj/pzz062.
PubMed 30951598Escamilla RF, Barrentine SW, Fleisig GS, Zheng N, Takada Y, Kingsley D, Andrews JR. Pitching biomechanics as a pitcher approaches muscular fatigue during a simulated baseball game. Am J Sports Med. 2007 Jan;35(1):23-33. doi: 10.1177/0363546506293025. Epub 2006 Sep 14.
PubMed 16973902
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training Following Acute Shoulder Injury In Baseball Players: Assessment of Efficacy in Return to Sport
- ClinicalTrials.gov ID
- NCT04248413
- Acronym / sponsor ID
- IRB00062859
- Conditions
- Musculoskeletal Injury
- Keywords
- Shoulder injury, Baseball injury, Muscle strength
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Too many obstacles starting study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation protocol | Other | Other: Standard physical rehabilitationPatients 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 | Device: Blood Flow Restriction Therapy, Other: Standard physical rehabilitationPatients 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. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction TherapyThe 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. | Device | Standard rehabilitation plus Blood Flow Restriction Therapy |
| Standard physical rehabilitationPatients 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. | Other | Standard rehabilitation plus Blood Flow Restriction Therapy, Standard rehabilitation protocol |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) questionnaire
Time frame: 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.
American Shoulder and Elbow Surgeons (ASES) questionnaire
Time frame: Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
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
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.
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
Time frame: Questionnaire assigned 6-months after completing the rehabilitation protocol.
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
Time frame: Questionnaire assigned 12-months after completing 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
Time frame: 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.
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time frame: Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
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
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.
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
Time frame: Questionnaire assigned 6-months after completing the rehabilitation protocol.
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
Time frame: Questionnaire assigned 12-months after completing 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
Time frame: 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.
Return to sport questionnaire
Time frame: Questionnaire assigned 12-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.
14 secondary outcomes
Muscle Strength
Time frame: Measured at baseline prior to the rehabilitation protocol.
Muscle Strength
Time frame: Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
Muscle Strength
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.
3D throwing motion analysis
Time frame: Performed at baseline prior to the rehabilitation protocol.
3D throwing motion analysis
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.
Human Growth Hormone (GH)
Time frame: Measured at baseline prior to the rehabilitation protocol.
Human Growth Hormone (GH)
Time frame: Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
Human Growth Hormone (GH)
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.
Interleukin 6 (IL-6)
Time frame: Measured at baseline prior to the rehabilitation protocol.
Interleukin 6 (IL-6)
Time frame: Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.
Interleukin 6 (IL-6)
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.
Insulin-Like Growth Factor (IGF)
Time frame: Measured at baseline prior to the rehabilitation protocol.
Insulin-Like Growth Factor (IGF)
Time frame: 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)
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Background: PubMed 24149640Abe 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.
- BackgroundAbe 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.
- Background: PubMed 27661420Blair JA, Eisenstein ED, Pierrie SN, Gordon W, Owens JG, Hsu JR. Lower Extremity Limb Salvage: Lessons Learned From 14 Years at War. J Orthop Trauma. 2016 Oct;30 Suppl 3:S11-S15. doi: 10.1097/BOT.0000000000000669.
- Background: PubMed 30638439Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Sports Health. 2019 Mar/Apr;11(2):149-156. doi: 10.1177/1941738118821929. Epub 2019 Jan 14.
- Background: PubMed 12671624Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
- BackgroundCancio J, Rhee P. Blood Flow Restriction Therapy after Non-Operative Management of Distal Radius Fracture: A Randomized Controlled Pilot Study. Journal of Hand Therapy. 2018;31(1).
- Background: PubMed 23038786Clarsen B, Myklebust G, Bahr R. Development and validation of a new method for the registration of overuse injuries in sports injury epidemiology: the Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire. Br J Sports Med. 2013 May;47(8):495-502. doi: 10.1136/bjsports-2012-091524. Epub 2012 Oct 4.
- Background: PubMed 26991562Conte S, Camp CL, Dines JS. Injury Trends in Major League Baseball Over 18 Seasons: 1998-2015. Am J Orthop (Belle Mead NJ). 2016 Mar-Apr;45(3):116-23.
- Background: PubMed 20019641Credeur DP, Hollis BC, Welsch MA. Effects of handgrip training with venous restriction on brachial artery vasodilation. Med Sci Sports Exerc. 2010 Jul;42(7):1296-302. doi: 10.1249/MSS.0b013e3181ca7b06.
- Background: PubMed 30685283Cvetanovich GL, Gowd AK, Liu JN, Nwachukwu BU, Cabarcas BC, Cole BJ, Forsythe B, Romeo AA, Verma NN. Establishing clinically significant outcome after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2019 May;28(5):939-948. doi: 10.1016/j.jse.2018.10.013. Epub 2019 Jan 24.
- Background: PubMed 15607879Dahlgren LA, Mohammed HO, Nixon AJ. Temporal expression of growth factors and matrix molecules in healing tendon lesions. J Orthop Res. 2005 Jan;23(1):84-92. doi: 10.1016/j.orthres.2004.05.007.
- Background: PubMed 26446893Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen F Nicholson, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Therapy and Standard physical rehabilitation in people with Musculoskeletal Injury, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) questionnaire (time frame: Questionnaire assigned at baseline prior to the rehabilitation protocol.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04248413, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.