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Blood Flow Restriction Therapy for Tennis Elbow
N/A
Recruiting
Led By Julia Nuelle, MD
Research Sponsored by Julie Nuelle
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-65 years of age
Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks to 6 months
Awards & highlights
Study Summary
This trial is investigating whether a new pain medication can help people with tennis elbow.
Who is the study for?
This trial is for adults aged 18-65 with tennis elbow confirmed by a surgeon and ultrasound. Participants must read/write English and consent themselves. Excluded are those with vascular diseases, bruising issues, infections, cancer, diabetes, prior injections for the condition, recent deep vein thrombosis, other arm disabilities, anticoagulant use or pregnancy.Check my eligibility
What is being tested?
The study tests a Blood Flow Restriction Device against Standard Physical Therapy to treat tennis elbow. It aims to see if reducing blood flow can quickly lessen pain and improve recovery compared to usual therapy methods.See study design
What are the potential side effects?
Potential side effects may include discomfort from the restriction device or standard physical therapy techniques like soreness or increased pain in the treated area during rehabilitation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
My elbow pain has been confirmed as tennis elbow by a surgeon and ultrasound.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Define the effect of BFR training on pain with activity in patients with LE.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Blood Flow Restricted Physical TherapyActive Control1 Intervention
Physical therapy assisted by blood flow restriction per standard physical therapy protocol.
Group II: Physical TherapyPlacebo Group1 Intervention
For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham.
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Who is running the clinical trial?
Julie NuelleLead Sponsor
Julia Nuelle, MDPrincipal InvestigatorUniversity of Missouri Department of Orthopaedic Surgery
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I bruise easily.I have had surgery to remove lymph nodes in the upper part of my body.I have had a deep vein clot in the last year.I have an infection in my injured arm.I have had injections for tennis elbow before.I am between 18 and 65 years old.I am over 65 years old.My opposite arm has limited movement, weakness, or daily pain more than slight.I have cancer.My elbow pain has been confirmed as tennis elbow by a surgeon and ultrasound.I am currently on blood thinners.My diabetes is not well-controlled.I have uncontrolled issues with my blood vessels outside of my heart and brain.
Research Study Groups:
This trial has the following groups:- Group 1: Physical Therapy
- Group 2: Blood Flow Restricted Physical Therapy
Awards:
This trial has 0 awards, including: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.
Are individuals over fifty being enrolled in this trial?
"This experiment requires participants to be of legal age and not exceed 65 years old."
Answered by AI
Could I become a participant in this research initiative?
"This medical study is hoping to recruit 250 participants who have been diagnosed with lateral epicondylitis by an orthopaedic specialist and can confirm the diagnosis via ultrasound. Prospective volunteers must be aged 18-65, literate in English, and capable of providing written consent."
Answered by AI
Are there opportunities to participate in this experiment at the current time?
"Affirmative. According to clinicaltrials.gov, this medical trial is in the recruitment process and has been since May 20th 2022 when it was initially posted. It has been updated most recently on November 1st 2022 with a goal of enrolling 250 patients from one site."
Answered by AI
How many participants are engaged in this clinical research?
"Affirmative. According to clinicaltrials.gov, this medical study is recruiting participants at present - it was first advertised on May 20th 2022 and most recently modified on November 1st 2022. Presently, the trial requires 250 volunteers from one site."
Answered by AI
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