Blood Flow Restriction Training in Tennis Elbow (NCT07710976) | Clinical Trial Compass
CompletedNot Applicable
Blood Flow Restriction Training in Tennis Elbow
Turkey (Türkiye)60 participantsStarted 2025-02-28
Plain-language summary
Lateral epicondylitis (LE) is a common musculoskeletal disorder caused by repetitive overuse of the forearm extensor muscles. It is characterized by pain over the lateral epicondyle of the humerus, which may radiate to the surrounding tissues at the origin of the wrist extensor tendons. LE is one of the most frequent causes of lateral elbow pain, with a reported prevalence of approximately 1-3% in the general population.
Among conservative interventions, exercise-based rehabilitation is considered a cornerstone of management. In particular, exercise programs incorporating eccentric contractions have demonstrated superior clinical outcomes compared with several other exercise approaches and are therefore widely recommended.
Blood flow restriction training (BFRT) has recently emerged as an alternative rehabilitation strategy that promotes neuromuscular adaptations while using low mechanical loads. BFRT involves the application of a pneumatic cuff, tourniquet, or elastic band around the proximal portion of an extremity to partially restrict arterial inflow while substantially reducing venous return, thereby creating localized metabolic and hemodynamic stress during exercise.
The primary aim of this randomized controlled trial was to investigate the effects of BFRT on pain, functional status, pain-free grip strength, health-related quality of life, and ultrasonographic characteristics of the common extensor tendon in patients with lateral epicondylitis.
Who can participate
Age range
18 Years – 75 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:
* age between 18 and 75 years;
* clinical diagnosis of lateral epicondylitis based on medical history and physical examination;
* pain intensity of ≥4 on a 10-cm Visual Analog Scale (VAS) during daily activities;
* provision of written informed consent.
Exclusion Criteria:
* hypertension, diabetes mellitus, cardiovascular disease, peripheral vascular disease, previous deep vein thrombosis, or lymphedema;
* orthopedic, rheumatologic, or neurological disorders affecting the upper extremity;
* fibromyalgia;
* congenital or acquired elbow deformity;
* previous trauma, fracture, or surgery involving the affected upper extremity;
* cervical radiculopathy or peripheral neuropathy affecting the involved limb;
* receipt of any treatment for lateral epicondylitis within the preceding 3 months;
* skin lesions, infection, or open wounds at the cuff application site;
* bleeding disorders or current anticoagulant therapy;
* pregnancy;
* active malignancy or a history of malignancy;
* cognitive impairment or neurological or psychiatric disorders that could interfere with comprehension of study procedures or completion of outcome assessments.
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
1
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Timeframe: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).