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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor

71 Previous Clinical Trials

12,628 Total Patients Enrolled

Virginia Polytechnic Institute and State UniversityOTHER

142 Previous Clinical Trials

27,679 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any further participants being welcomed into this experiment?

"Clinicaltrials.gov confirms that this medical trial is still in search of patients, having been originally posted on May 26th 2022 and last modified one day prior."

Answered by AI

What demographics are considered ideal participants for this research?

"This research study is looking for 78 volunteers aged 50-75 with distal radius fractures that were caused by a fall onto an outstretched hand. Furthermore, open reduction internal fixation using volar plating (CPT 25607, 25608 and 25609) must be conducted to fulfil the requirements of this trial."

Answered by AI

How many applicants are being considered for this experiment?

"Yes, according to the information present on clinicaltrials.gov this research is presently searching for volunteers. This trial was first made available to the public on May 26th 2022 and has been updated just recently (May 25th). 78 participants are required from 1 medical centre."

Answered by AI