Evaluation of the Analgesic and Functional Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
研究概览
简要总结
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.
详细描述
6.1 Type of Study
International multicenter interventional, single-blind, randomized, controlled, parallel-group study in centers with practitioners trained in diagnosis.
Randomization is achieved by dedicated software.
6.2 Primary Endpoint
- Improvement in PRTEE questionnaire scores [10, 11, 12] before and after application of the Control roller (T) or the Joints & Muscles roller (AM) combined with simultaneous delivery of an emulsion composed notably of essential oils. An improvement of 20% [13] (minimum clinically significant threshold for epicondylitis) in the PRTEE score will be used as the success criterion.
- Improvement of the score at 1 month, 2 months, and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lateral epicondylitis of more than 3 months' duration, isolated and confirmed by clinical and ultrasonographic examination.
- •Failure of at least one prior rehabilitation treatment.
- •No ongoing physical treatment (shockwave therapy, physiotherapy) for at least 6 weeks, including a well-conducted rehabilitation.
- •Adults aged over 18 years.
排除标准
- •Manual workers in active employment conducive to lateral epicondylitis.
- •Occupational injury.
- •Patients who have received at least one treatment with PRP (platelet-rich plasma) or any other regenerative treatment.
- •Uncontrolled inflammatory or metabolic diseases.
- •Neuropsychological disorders preventing proper completion of the protocol.
- •Age under 18 years.
- •Person unable to understand French.
- •Associated osteoarticular and neurological pathologies of the upper limb.
- •Known allergy to any component of the essential oils used.