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NCT07615972
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Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis

Sponsor: Puressentiel

View on ClinicalTrials.gov

Summary

Tennis elbow, also known as lateral epicondylitis, is a pathology of the enthesis of tendons attaching near or directly on the lateral epicondyle of the humerus. Lateral epicondylitis is characterized by progressive pain localized on the outer edge of the elbow, reproduced by palpation, stretching, and/or isometric resistance contraction of the lateral epicondylar muscles. This pain may be accompanied by a deficit in muscle strength compared to the opposite side. The diagnosis is mainly clinical, although imaging tests may be considered in cases of doubt or if the pain persists despite appropriate therapeutic management. There is no specific treatment for tennis elbow that has been proven to be effective. However, starting treatment can speed up the return to sporting activities and prevent the condition from becoming chronic. This study aims to fill this gap by evaluating the effectiveness of a simple and natural treatment for the symptoms of tennis elbow: a roller equipped with a ball that facilitates self-massage with simultaneous diffusion of an essential oil-based emulsion. Objective : To evaluate the analgesic and functional efficacy of a roller device that facilitates mechanical self-massage through the simultaneous diffusion of an emulsion composed mainly of essential oils in the treatment of chronic lateral epicondylitis. Participants : Lateral epicondylitis lasting more than 3 months, isolated and confirmed by clinical examination and ultrasound, in subjects aged 18 years and older. Procedures : Clinical examination to confirm the diagnosis of lateral epicondylitis (specific tests for pain on stretching and palpation, elimination of differential diagnoses), and ultrasound. * Assessment using the PRTEE (Patient-Rated Tennis Elbow Evaluation) questionnaire (French version). * Assessment using the numerical pain rating scale (0-10), * Assessment of the location associated with the pain. * Treatment instructions: 2 daily applications, morning and evening, involving mechanical friction of the epicondylar and muscular area for 2 minutes, i.e., a total of 2 x 70 roller rotations (70 roller rotations on the tendon and 70 roller rotations on the muscle) for 3 months. The same parameters will be assessed one month, two months, and three months after use of the device. Patients will be randomized to receive either an Articulations \& Muscles (AM) roller or a Control (T) roller. * Assessment of analgesic and anti-inflammatory consumption. Each participant will be given a daily monitoring diary to record their analgesic and anti-inflammatory intake.

Official title: Evaluation of the Analgesic and Functional Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-06-01

Completion Date

2028-09-01

Last Updated

2026-05-29

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Active comparator

Active automassage with roller Puressentiel

DEVICE

auto massage twice a day

automassage twice a day with a non active roller Puressentiel

DEVICE

automassge with an empty roller Puressentiel

To evaluate the analgesic and functional efficacy of a roller device that facilitates mechanical self-massage through the simultaneous diffusion of an emulsion composed mainly of essential oils in the treatment of chronic lateral epicondylitis.