BFR Therapy Following DRF

NCT05396521 | Completed DMC

• 1 other identifier: IRB-21-1514
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Distal Radius Fracture

Keywords

Blood Flow Restriction

Outcome Measures

Primary Outcomes (2)

• PROMIS Pain interference SF V1.1

  3 months

• PRWE

  3 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Other: Standard of Care Physical Therapy

Blood Flow Restriction Supplemented

EXPERIMENTAL

Other: Blood Flow Restriction

Interventions

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.

Blood Flow Restriction Supplemented

Standard of Care Physical Therapy OTHER

Group 1 (Control) will receive standard of care physical therapy.

Standard of Care

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Related Publications (14)

• Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536916/

  PMID: 30725601 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.

  PMID: 29169594 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.

  PMID: 33892883 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.

  PMID: 9459541 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.

  PMID: 11128848 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.

  PMID: 24691032 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.

  PMID: 21840132 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.

  PMID: 21529326 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.

  PMID: 22802591 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.

  PMID: 1618195 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.

  PMID: 18466185 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.

  PMID: 34580509 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.

  PMID: 35415515 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.

  PMID: 30922707 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: May 26, 2022
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: October 9, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)