Effectiveness of High Frequency Currents (Tecarethérapie) in Patients With Lateral Elbow Tendonopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- change in the "Patient-Rated Tennis Elbow Evaluation" score
研究概览
简要总结
This RCT aims at investigating the effectiveness of the "Tecaretherapy" in patients with lateral elbow tendinopathy.
60 patients will be randomized into one of the following 3 groups:
- "Conventional physiotherapy treatment (CPT)" (massage, eccentric exercises, stretching);
- "CPT + Tecare" (idem CPT group + tecaretherapy during the eccentric exercises)
- "CPT + Placebo Tecare" (idem "CPT + Tecare" group but with an inactive Tecare device) The treatment will include 18 30-minute sessions
详细描述
This RCT aims at investigating the effectiveness of the "Tecaretherapy" in patients with lateral elbow tendinopathy.
60 patients will be randomized into one of the following 3 groups:
- "Conventional physiotherapy treatment (CPT)" (massage, eccentric exercises by means of an isokinetic dynamometer, stretching);
- "CPT + Tecare" (idem CPT group + Tecaretherapy during the eccentric exercises)
- "CPT + Placebo Tecare" (idem "CPT + Tecare" group but with an inactive "Tecare" device) The treatment will include 18 30-minute sessions.
The "Tecaretherapy" consists in using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process.
Outcome sessions will be organized at baseline, after the first 9 sessions, at the end of the treatment as well as 3 and 6 months after the initial treatment session.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The patients receiving the "Placebo Tecare" will be blinded by using an identical device as in the active group but which cannot provide any current
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from a chronic lateral elbow tendinopathy confirmed by echography
排除标准
- •with contra-indications for a Tecaretherapy (Pace maker, insuline pump, pregnancy, infection, fever, cancer, thrombophlebitis)
- •reporting injections and/or shockwaves in the past (for the tendinopathy)
- •with an associated neurogenic dysfunction
结局指标
主要结局
change in the "Patient-Rated Tennis Elbow Evaluation" score
时间窗: up to 6 months
This questionnaire, developped for patients with elbow tendinopathy, consists of one part dealing with pain and a second part dealing with function. Each of the 5 items in part 1 is scored using a NRS, ranging from 0 (no pain) to 10 (worst pain imaginable). Part 2 is subdivided into Specific Activities (6 items) and Usual Activities (4 items). The 10 items of part 2 use a scale of 0 (no difficulty) to 10 (unable to perform an activity) to rate function. The total score is the combined score that rates pain and disability of equal importance. The pain score total (out of 50 points) and the functional subscale (60 points for specific activities, plus 40 points for usual activities to give a function subscale out of 100 points /2 to provide the remaining 50%) provide a total score, ranging from 0 (no pain and no functional impairment) to 100 (worst pain imaginable with a very significant functional deficit).
次要结局
- change in pain Intensity(up to 6 months)
- change in pain Pressure thresholds(up to 6 months)
研究者
Christophe Demoulin
Associated Professor
University of Liege