CLINICAL TRIAL

Blood flow restriction tourniquet for Tennis Elbow

Recruiting · 18+ · All Sexes · Akron, OH

This study is evaluating whether a blood flow restriction tourniquet may help improve tennis elbow.

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About the trial for Tennis Elbow

Eligible Conditions
Tennis Elbow · Lateral Epicondylitis

Treatment Groups

This trial involves 2 different treatments. Blood Flow Restriction Tourniquet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Blood flow restriction tourniquet
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Evidence based physical/occupational therapy
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The diagnoses included are lateral elbow pain, lateral epicondylitis, or lateral epicondylalgia, more general diagnoses elbow tendinitis or elbow pain will be included if their clinical picture at physical therapy meets criteria for lateral epicondylitis.
If the inclusion diagnosis is other than lateral epicondylitis or tennis elbow (such as elbow pain), we will confirm the diagnosis at the first therapy visit with tenderness at the lateral epicondyle and/or pain with resisted wrist/long finger extension at the lateral epicondyle.
Pain for 4 weeks or more.
All participants must be between the age of 18 and 70 years old and have had pain for 4 weeks or more.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Blood flow restriction tourniquet will improve 1 primary outcome and 4 secondary outcomes in patients with Tennis Elbow. Measurement will happen over the course of at final therapy visit up to 12 weeks after enrollment.

Maximum grip strength
AT FINAL THERAPY VISIT UP TO 12 WEEKS AFTER ENROLLMENT
Change in maximum grip strength on dynamometer
Pain free grip strength
AT FINAL THERAPY VISIT UP TO 12 WEEKS AFTER ENROLLMENT
Change in pain free grip strength on dynamometer
Numeric pain rating scale
12 MONTHS
change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain.
Other treatments received
12 MONTHS
We will collect data on whether the patient sought or received treatments beyond physical/occupational therapy over the 12 months of enrollment in the study
Patient rated tennis elbow evaluation (PRTEE)
12 MONTHS
Change in score on 'Patient rated tennis elbow evaluation' total score. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100. Includes pain subscale (0-50) Specific activities subscale (0-60) Usual activities subscale (0-40) Function Subscale= (specific activities score + usual activities score)/2 (0-50) Total Score= Pain subscale + Function Subscale (0-100)

Who is running the study

Principal Investigator
A. L.
Aaron Lear, Director of Primary Care Sports Medicine
Akron General Medical Center

Patient Q & A Section

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

What are common treatments for tennis elbow?

Tennis elbow can respond to splinting with a combination of conservative treatment (e.g. rest, elevation, and compression) and manual therapy (e.g. heat and ice) with variable success rates using no conservative treatment. Additional studies examining these therapies are warranted.

Anonymous Patient Answer

Can tennis elbow be cured?

There is no cure for tennis elbow. Exercise of some degree of repetitive use may reduce symptoms, but a large degree of repetitive use does not.

Anonymous Patient Answer

What causes tennis elbow?

The pathogenesis of tennis elbow and golfer's elbow is similar and likely the result of repetitive microtrauma which causes fatigue and muscle denervation. There is evidence for the development of tenosynovitis (inflammation of a tendon sheath) which may lead to the development of tendinitis. It is unknown how a causative link exists between this pathological process and pain, which may therefore represent an inappropriate response.

Anonymous Patient Answer

What is tennis elbow?

Tennis elbow is a disorder of the proximal humeral collateral ligament that presents with pain and stiffness most often in the elbow, wrist and forearm. It usually strikes tennis and squash players in their mid 30s. Tennis elbow is more than likely to occur when tennis players develop a rapid, repetitive wrist extension while playing squash or tennis. Treatment for tennis elbow is variable depending on the cause. There are several different explanations for tennis elbow, but a combination of the repetitive wrist extension, local hyperaesthesia (numbness) and peripheral neuropathy suggests that the compression of some nerve (or nerve roots) is happening. There is however no single definitive treatment yet and most doctors are unable to provide a correct diagnosis and advice for tennis elbow.

Anonymous Patient Answer

How many people get tennis elbow a year in the United States?

Tennis elbow is common: in this study, 24.7% of participants reported tennis elbow symptoms at some point in their lives. Tennis elbow may affect boys and girls of all ages, and is common among men and women.

Anonymous Patient Answer

What are the signs of tennis elbow?

Tennis elbow can be diagnosed before major signs occur and treated with a high percentage of patients being back in sports and activity in 3 months. This would have a tremendous impact on return to competitive tennis.

Anonymous Patient Answer

Has blood flow restriction tourniquet proven to be more effective than a placebo?

No evidence was found to support the claims that WBFRT is effective in reducing discomfort or improving outcome from the tennis shoulder. Based on our experience using WBFRT, this treatment does not appear to be a useful tool for reducing injury to the shoulder.

Anonymous Patient Answer

How serious can tennis elbow be?

Tennis elbow has been shown to affect up to 8% of amateur tennis players, but it can be prevented by practicing proper technique. Most tennis players will be free of pain or discomfort after a period of rest. However, tennis elbow is a chronic condition in which a tennis player should seek medical consultation. Treatment options for tennis elbow may include medication or physical therapy. Tennis elbow has not been listed as a permanent injury category by the United States Tennis Association (USTA), but an injury may be incurred if the use of a tennis racket or any strokes improperly applied could potentially cause pain for the player. tennis elbow or tennis arm is not always seen as a serious issue because most tennis players will experience the condition less than 2 years.

Anonymous Patient Answer

What are the common side effects of blood flow restriction tourniquet?

There might be some degree of pain, irritation and hematoma at the application site that may require more time for healing. For beginners and those who want to avoid a prolonged tourniquet, it is advisable to use the tourniquet for short periods and move towards a more experienced person before using it for prolonged sessions with a longer tourniquet and a more painful application site.

Anonymous Patient Answer

What is the average age someone gets tennis elbow?

Tennis elbow is not a rare condition. At least one review has estimated the incidence of tennis elbow in symptomatic individuals at 1 per 10 000 per year or about 40 per 1000 in the general population. However, this estimate did not appear consistent with our own data. Studies have found that roughly one-third of players with tennis elbow do not improve with proper treatment and that about half of patients do not respond to medication. Results from a recent paper suggest that tennis elbow should be considered one of the most common tennis-related conditions. Although tennis elbow is not a rare condition, it may be underrecognized. Studies and treatments may overestimate what is seen in the population as a whole.

Anonymous Patient Answer

Who should consider clinical trials for tennis elbow?

Although evidence to support or refute the use of medication to prevent tennis elbow is poor, more prospective, well-designed studies of medication for treating tennis elbow are needed.

Anonymous Patient Answer

How does blood flow restriction tourniquet work?

Tourniquet application decreases the elbow extension torque and velocity, while knee flexion torque, velocity and range of motion remain constant at 5 minutes in a resting forearm position, and therefore the blood flow restriction is less effective during exercise. Application of the tourniquet did not cause pain.

Anonymous Patient Answer
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