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| Name | Class |
|---|---|
| Virginia Polytechnic Institute and State University | OTHER |
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This study's goal is to evaluate whether blood flow restriction supplemented therapy is a superior therapy compared to traditional standard of care while recovering from a surgery that repairs distal radius fractures. In order to measure this, subjects will be randomly assigned to either the traditional therapy group (with standard of care) or a blood flow restriction supplemented therapy group. All patients involved in this study will have had a distal radius fracture that is repaired with a technique called volar plating and the procedure will be done via an open technique. All subjects will be asked to fill out questionnaires that assess their pain and wrist functionality throughout the course of the study. These measurements will help understand whether the supplemented therapy is effective at reducing pain and improving functionality for patients who are recovering from this injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator |
| |
| Blood Flow Restriction Supplemented | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction | Other | Group 2 (experimental) will receive standard of care physical therapy to be done with blood flow restriction therapy (BFR). This method includes standard of care physical therapy while occluding blood flow. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Pain interference SF V1.1 | 3 months | |
| PRWE | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
High energy mechanism
any concomitant injury to the affected limb
Bilateral distal radius fracture
Revision procedures
Worker's compensation status
Non-English speaking
No Internet Access
Inability to provide informed consent
Patients with known lymphovascular disorders, including peripheral arterial disease (PAD), prior deep vein thrombosis (DVT) or chronic lymphedema
Patients with known genetic or other hypercoagulability disorders including those on long-term anticoagulation or anti-platelet therapy (other than prophylactic aspirin)
Uncontrolled hypertension
Patients with dialysis catheters or AV fistula
Any other medical condition that affects the risk profile of the patient or that affects the normal physiologic function of the circulatory system of the extremities, based on sole discretion and medical judgement of the Primary Investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30725601 | Background | Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536916/ | |
| 29169594 | Background | Pope D, Tang P. Carpal Tunnel Syndrome and Distal Radius Fractures. Hand Clin. 2018 Feb;34(1):27-32. doi: 10.1016/j.hcl.2017.09.003. |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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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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| Standard of Care Physical Therapy | Other | Group 1 (Control) will receive standard of care physical therapy. |
|
| 33892883 | Background | Kooner P, Grewal R. Is Therapy Needed After Distal Radius Fracture Treatment, What Is the Evidence? Hand Clin. 2021 May;37(2):309-314. doi: 10.1016/j.hcl.2021.02.012. |
| 9459541 | Background | Shinohara M, Kouzaki M, Yoshihisa T, Fukunaga T. Efficacy of tourniquet ischemia for strength training with low resistance. Eur J Appl Physiol Occup Physiol. 1998;77(1-2):189-91. doi: 10.1007/s004210050319. |
| 11128848 | Background | Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011. |
| 24691032 | Background | Gundermann DM, Walker DK, Reidy PT, Borack MS, Dickinson JM, Volpi E, Rasmussen BB. Activation of mTORC1 signaling and protein synthesis in human muscle following blood flow restriction exercise is inhibited by rapamycin. Am J Physiol Endocrinol Metab. 2014 May 15;306(10):E1198-204. doi: 10.1152/ajpendo.00600.2013. Epub 2014 Apr 1. |
| 21840132 | Background | Loenneke JP, Fahs CA, Wilson JM, Bemben MG. Blood flow restriction: the metabolite/volume threshold theory. Med Hypotheses. 2011 Nov;77(5):748-52. doi: 10.1016/j.mehy.2011.07.029. Epub 2011 Aug 12. |
| 21529326 | Background | Fry CS, Rasmussen BB. Skeletal muscle protein balance and metabolism in the elderly. Curr Aging Sci. 2011 Dec;4(3):260-8. doi: 10.2174/1874609811104030260. |
| 22802591 | Background | Nielsen JL, Aagaard P, Bech RD, Nygaard T, Hvid LG, Wernbom M, Suetta C, Frandsen U. Proliferation of myogenic stem cells in human skeletal muscle in response to low-load resistance training with blood flow restriction. J Physiol. 2012 Sep 1;590(17):4351-61. doi: 10.1113/jphysiol.2012.237008. Epub 2012 Jul 16. |
| 1618195 | Background | Moritani T, Sherman WM, Shibata M, Matsumoto T, Shinohara M. Oxygen availability and motor unit activity in humans. Eur J Appl Physiol Occup Physiol. 1992;64(6):552-6. doi: 10.1007/BF00843767. |
| 18466185 | Background | Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3. |
| 34580509 | Background | Shakeel R, Khan AA, Ayyub A, Masood Z. Impact of strengthening exercises with and without blood flow restriction on quadriceps of knee osteoarthritis patients. J Pak Med Assoc. 2021 Sep;71(9):2173-2176. doi: 10.47391/JPMA.377. |
| 35415515 | Background | Cheema AS, O'Brien PJ, Broekhuyse HM, Lefaivre KA. Measuring Outcomes Over Time in Distal Radius Fractures: A Comparison of Generic, Upper Extremity-Specific and Wrist-Specific Outcome Measures. J Hand Surg Glob Online. 2020 Aug 14;2(5):272-276. doi: 10.1016/j.jhsg.2020.06.006. eCollection 2020 Sep. |
| 30922707 | Background | MacDermid JC. The PRWE/PRWHE update. J Hand Ther. 2019 Apr-Jun;32(2):292-294. doi: 10.1016/j.jht.2019.01.001. Epub 2019 Mar 25. No abstract available. |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |