Distal Radius Fracture
Conditions
Keywords
Blood Flow Restriction
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.
Interventions
OTHERBlood 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.
Group 1 (Control) will receive standard of care physical therapy.
Sponsors
Virginia Polytechnic Institute and State University
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PROMIS Pain interference SF V1.1 | 3 months |
| PRWE | 3 months |
Countries
United States
Outcome results
None listed