UnknownNot Applicable

Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia Traditional Treatment

United States104 participantsStarted 2021-03-01

Plain-language summary

The purpose of this study is to compare the clinical effectiveness and outcomes between current evidence based clinical care and use of personalized blood flow restriction training in the treatment of lateral epicondylalgia ("tennis elbow").

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of lateral elbow pain (e.g. "tennis elbow" or wrist extensor tendinopathy)
. Between the ages of 18-65
. Elbow pain for 4 weeks or more

Exclusion criteria

. Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
. Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow.
. Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
. Current fracture in affected arm
. History of crush injury to affected arm
. Any surgery on affected arm in last 1 year
. Surgery within last year on contralateral upper extremity
. History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numerical Pain Rating Scale

Timeframe: Taken at initial intake, after completion of each treatment session (up to 12 total sessions following initial evaluation), and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions

Patient-rated tennis elbow evaluation (PRTEE)

Timeframe: Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions

Grip Strength

Timeframe: Taken at initial intake, and at the 3-week, 6-week, 3-month, and 6-month follow-up sessions

Trial details

NCT IDNCT04607356

SponsorUnited States Naval Medical Center, San Diego

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-05-15

Contact for this trial

Tara Haugen, MSOT

570-856-4375 tara.a.haugen.mil@mail.mil

View on ClinicalTrials.gov More Tennis Elbow trials