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Behavioural Intervention
Blood Flow Restriction + Physical Therapy for Tennis Elbow
N/A
Waitlist Available
Led By Aaron Lear, MD, CAQ
Research Sponsored by Akron General Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All participants must be between the age of 18 and 70 years old and have had pain for 4 weeks or more.
Pain for 4 weeks or more.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial compares two different types of therapy for tennis elbow.
Who is the study for?
This trial is for individuals aged 18-70 with tennis elbow experiencing pain for at least 4 weeks. It's not suitable for pregnant women, those unable to consent, recent surgery on the arms, active infections, cancer treatments, certain blood and vascular disorders, or if they've had injections in the affected area within the last 3 months.Check my eligibility
What is being tested?
The study compares standard physical therapy against a combination of physical therapy with a blood flow restriction tourniquet to treat tennis elbow. Participants are randomly assigned to one of these two approaches in an open label setting.See study design
What are the potential side effects?
Potential side effects may include discomfort from the tourniquet, bruising or swelling at the application site. Since it involves restricting blood flow temporarily, there might be temporary numbness or tingling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old and have had pain for over 4 weeks.
Select...
I have been experiencing pain for over 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient rated tennis elbow evaluation (PRTEE)
Secondary outcome measures
Maximum grip strength
Numeric pain rating scale
Other treatments received
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Blood flow restriction with physical/occupational therapyExperimental Treatment1 Intervention
physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period).
Group II: Evidence based physical/occupational therapyActive Control1 Intervention
evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet
Find a Location
Who is running the clinical trial?
Akron General Medical CenterLead Sponsor
6 Previous Clinical Trials
238 Total Patients Enrolled
Cleveland Clinic Akron GeneralLead Sponsor
7 Previous Clinical Trials
442 Total Patients Enrolled
Aaron Lear, MD, CAQPrincipal Investigator - Cleveland Clinic Akron General
Akron Children's Hospital, Akron General Medical Center, Akron General Orthopaedic Clinic
Ohio State University College Of Medicine (Medical School)
Fairview Hlth Sys-Fairview Gen (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have sickle cell anemia or the trait.I have a broken bone in my arm.I am between 18 and 70 years old and have had pain for over 4 weeks.I am currently diagnosed with cancer and receiving treatment.I had surgery on the opposite arm within the last year.I have had surgery to remove lymph nodes due to cancer.I do not have elbow sprain, elbow osteoarthritis, or nerve pain in my arm.I have not had injections for pain or inflammation in the affected area in the last 3 months.You have previously experienced a serious injury to your arm that caused it to be crushed.I have had surgery on my elbow for ligament, bone, or soft tissue repair.I have had surgery on my affected arm in the past year.I do not have an active infection.I am unable to give consent for medical procedures.My elbow pain will be diagnosed at my first therapy visit.I have a history of blood clots or vascular disease.You have a history of fainting or passing out when pressure is applied to your body, like during a massage or when a blood pressure cuff is used.I am on kidney dialysis.I have been diagnosed with tennis elbow or similar elbow pain.I have been experiencing pain for over 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Evidence based physical/occupational therapy
- Group 2: Blood flow restriction with physical/occupational therapy
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.
Is recruitment for this experiment still ongoing?
"Clinicaltrials.gov lists this trial as being in the process of recruiting patients, which began on July 1st 2019 and was last updated on December 8th 2021."
Answered by AI
To what extent are participants participating in this research?
"Affirmative. The details on clinicaltrials.gov make clear that as of today, this medical trial is recruiting participants. It was initially posted on the 1st of July 2019 and most recently updated on 8th December 2021. 44 individuals need to be enrolled at a single site for it to reach completion."
Answered by AI
Who is eligible to participate in this research study?
"To be considered for this clinical trial, individuals between the age of majority and 70 must have been diagnosed with lateral epicondylitis. There is space allocated on the study to admit forty-four eligible patients."
Answered by AI
Does the minimum age requirement for this trial extend beyond 20 years?
"Those of legal age (over 18) and under the age of 70 are eligible to sign up for this trial."
Answered by AI
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