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Blood Flow Restriction Therapy for Wrist Fractures

N/A
Recruiting
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Outpatients undergoing distal radius fracture open reduction internal fixation using volar plating (CPT 25607, 25608, and 25609)
Age 50 - 75
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial is studying whether blood flow restriction therapy is better than traditional therapy for people recovering from surgery to fix a broken wrist.

Who is the study for?
This trial is for outpatients aged 50-75 who have had a distal radius fracture fixed with volar plating after falling on an outstretched hand. It's not for those with uncontrolled high blood pressure, blood clotting disorders, certain vascular issues, or severe injuries like from car accidents or falls from heights.Check my eligibility
What is being tested?
The study compares traditional physical therapy to the same therapy supplemented with blood flow restriction (BFR) in patients recovering from wrist surgery due to fractures. Participants are randomly placed into one of these two groups and will complete questionnaires about pain and wrist function.See study design
What are the potential side effects?
While specific side effects aren't listed here, BFR therapy may cause discomfort, bruising or swelling at the restriction site. Standard physical therapy could lead to muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having surgery to fix a wrist fracture with a specific technique.
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I am between 50 and 75 years old.
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I injured myself by falling on an outstretched hand.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PROMIS Pain interference SF V1.1
PRWE

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Blood Flow Restriction SupplementedExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor
73 Previous Clinical Trials
12,699 Total Patients Enrolled
Virginia Polytechnic Institute and State UniversityOTHER
145 Previous Clinical Trials
27,919 Total Patients Enrolled

Media Library

Standard of Care Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05396521 — N/A
Distal Radius Fracture Research Study Groups: Blood Flow Restriction Supplemented, Standard of Care
Distal Radius Fracture Clinical Trial 2023: Standard of Care Physical Therapy Highlights & Side Effects. Trial Name: NCT05396521 — N/A
Standard of Care Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05396521 — N/A
~26 spots leftby May 2025
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