CompletedNot Applicable

Effectiveness of Low-Load Resistance Training With Blood Flow Restriction in Lateral Epicondylitis

Turkey (Türkiye)58 participantsStarted 2025-07-14

Plain-language summary

Lateral epicondylitis, commonly known as tennis elbow, is a frequent musculoskeletal condition that causes pain, reduced grip strength, and functional limitations in daily activities. Exercise-based rehabilitation is a key component of treatment; however, the optimal exercise approach remains uncertain. Low-load resistance training combined with blood flow restriction (LLRT-BFR) has emerged as a promising method that may enhance training effects while using lower exercise loads, potentially reducing mechanical stress on the affected tissues while providing benefits comparable to high-load resistance training. The purpose of this study is to evaluate the clinical and ultrasonographic effects of LLRT-BFR in patients with lateral epicondylitis. Adults aged 18-65 years with a recent diagnosis of lateral epicondylitis who meet predefined inclusion and exclusion criteria will be enrolled and randomly assigned to one of two exercise-based treatment groups. Both groups will participate in the same supervised low-load resistance exercise program, while one group will perform the exercises with blood flow restriction and the other group will receive a sham application without meaningful blood flow restriction. Participants will undergo supervised exercise sessions twice weekly for six weeks. Outcomes will be assessed at baseline, on the first day after completion of treatment, and at 4 and 12 weeks during follow-up. The primary outcome will focus on functional status, while secondary outcomes will include pain intensity, pain sensitivity, grip strength, ultrasonographic measurements of tendon and muscle structure, and patient-reported treatment satisfaction. By comparing these two exercise approaches, this study aims to provide evidence regarding the effectiveness and safety of LLRT-BFR and to clarify its potential role in the rehabilitation of patients with lateral epicondylitis.

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: * Patients with a clinical diagnosis of lateral epicondylitis established by a physician * Presence of symptoms consistent with lateral epicondylitis for more than 2 weeks and less than 12 weeks * Adults aged 18 to 65 years * Visual Analog Scale (VAS) pain score ≥ 3 * Willingness to participate in the study and provision of written informed consent Exclusion Criteria: * History of major trauma to the elbow or surrounding region within the past 1 month * Receipt of physical therapy for the elbow or surrounding region within the past 1 year * History of corticosteroid or other injection therapies to the elbow or surrounding region within the past 1 year * History of fracture involving the elbow or surrounding region * History of surgery involving the elbow or surrounding region * Presence of rheumatologic diseases affecting the elbow or surrounding region * History of peripheral vascular disease * History of coagulation disorders * History of severe cardiovascular disease * History of uncontrolled hypertension * History of uncontrolled diabetes mellitus * Clinical findings consistent with cervical radiculopathy causing elbow pain or muscle weakness in the affected upper extremity * Clinical findings consistent with shoulder pathologies causing elbow pain or muscle weakness in the affected upper extremity * Restricted range of motion of the elbow joint detected on clinical examination * History of severe psychiatric disorders * History of malignancy * Preg…

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

Patient-Rated Tennis Elbow Evaluation (PRTEE) Total Score

Timeframe: Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

Trial details

NCT IDNCT07351942

SponsorSisli Hamidiye Etfal Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-15

View on ClinicalTrials.gov More Lateral Epicondylitis trials