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BFR Therapy for Biceps Tendon Rupture
N/A
Waitlist Available
Led By Kelechi Okoroha, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Awards & highlights
Study Summary
This trial will study the effects of using BFR therapy after surgically repairing a torn biceps tendon or medial patellofemoral ligament.
Who is the study for?
This trial is for adults aged 18-80 who have experienced a biceps tendon tear or patellar dislocation and are undergoing repair surgery. Candidates must be able to tolerate blood flow restriction (BFR) therapy and complete physical therapy. People with a history of deep vein thrombosis, neurovascular injury, peripheral vascular disease, or those needing revision surgeries are not eligible.Check my eligibility
What is being tested?
The study is testing the effectiveness of Blood Flow Restriction (BFR) Therapy when used alongside standard physical therapy after surgical repair of either the biceps tendon or medial patellofemoral ligament due to tears.See study design
What are the potential side effects?
Participants may experience discomfort from BFR therapy such as muscle soreness or fatigue. If they cannot tolerate BFR or develop complications like swelling or numbness in the limb, they will be removed from the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in strength
Secondary outcome measures
Change in range of motion
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Conventional rehabilitation plus blood flow restriction (BFR) therapyExperimental Treatment1 Intervention
Following standard of care surgery, subjects will immediately be started in standard of care physical therapy. Additionally, a BFR Cuff will be applied during physical therapy.
Group II: Conventional rehabilitationActive Control1 Intervention
Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,016 Total Patients Enrolled
Kelechi Okoroha, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
188 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between the ages of 18 and 80 and have torn your biceps, and are scheduled to have surgery to repair it. You may also be eligible if you have a similar knee condition called MPFLR.You have had a previous surgery on your biceps or MPFLR, have a history of blood clot, nerve injury or poor blood circulation, cannot handle BFR treatment or physical therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional rehabilitation plus blood flow restriction (BFR) therapy
- Group 2: Conventional rehabilitation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment accommodate participants who are over 30 years of age?
"This clinical investigation is accepting individuals between the ages of 18 to 80 years old."
Answered by AI
Are there any openings for participants in this experiment?
"Based on the latest evidence from clinicaltrials.gov, this particular medical trial is no longer actively recruiting; it was initially posted to the website on January 1st 2023 and last updated September 28th 2022. Nevertheless, 131 alternative trials are currently seeking participants."
Answered by AI
Is my participation eligible for this trial?
"This experiment is open to 68 people who have experienced dislocations. The age range accepted goes from 18 - 80. Enrollees must come from the ambulatory sports medicine clinics and meet either of two criteria: having undergone biceps repair or MPFLR (Medial Patellofemoral Ligament Reconstruction)."
Answered by AI
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