BFR Therapy Following DRF

Distal Radius Fracture Clinical Trial

Official title:

Utilizing Blood Flow Restriction Therapy Following ORIF Treated Distal Radius Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396521
• Other study ID #: IRB-21-1514
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2022
• Source: Carilion Clinic
• Contact: Evan P Sandefur
• Phone: 262-893-2786
• Email: evansandefur[@]vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: April 1, 2025
• Est. primary completion date: May 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Outpatients undergoing distal radius fracture open reduction internal fixation using volar plating (CPT 25607, 25608, and 25609)

• Age 50 - 75

• Fall onto outstretched hand injury

Exclusion Criteria:

• High energy mechanism

• Fall from an elevated position greater than 12 inches

• Motor vehicle collision

• Any activity involving a powered vehicle (scooter, car, truck, ATV, motorcycle, tractor, etc.)

• 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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Radius Fractures

Intervention

Other:
• Blood Flow Restriction
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.
• Standard of Care Physical Therapy
Group 1 (Control) will receive standard of care physical therapy.

Locations

Country	Name	City	State
United States	Carilion Clinic	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Carilion Clinic	Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. 2022 May 1. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536916/ — View Citation

Fry CS, Rasmussen BB. Skeletal muscle protein balance and metabolism in the elderly. Curr Aging Sci. 2011 Dec;4(3):260-8. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS Pain interference SF V1.1		3 months
Primary	PRWE		3 months