Contribution of an Electrotherapy Technique Such as TENS ECOMODYN® vs Electrotherapy Only Type TENS in the Management of Myofascial Syndrome After Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- The main objective is to evaluate the effectiveness of TENS and TENS ECOMODYN® on the management of chronic breast pain after surgery.
研究概览
简要总结
Myofascial syndrome is defined as "musculoskeletal pain characterized by local and referred pain perceived to be deep and constant, and by the presence of myofascial trigger points in any part of the body" Post-breast surgery myofascial syndrome affects up to 44.7% of operated women, mainly on the muscles of the greater shoulder girdle. The repercussions are significant, functional, somatic, psychological and socio-professional affecting the quality of life. The treatments offered may or may not be medicinal. Transcutaneous electrical nerve stimulation (TENS) is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Male or female who had first breast cancer surgery, regardless of the type of surgery
- •Age ≥ 18 years
- •Patients with refractory pain with myofascial syndrome, with a numerical scale ≥ 4
- •Topical treatment for refractory pain completed more than 30 days ago
- •Healthy, non-irritated skin on painful areas to treat
- •Patient with a third party who can attend visits M0 and M2.5
- •Obtaining the signed written consent of the patient
- •Major patient affiliated to a social security scheme
排除标准
- •Patient who has used TENS before on the muscles affected by the myofascial syndrome
- •Post-surgery management of the affected area by a physiotherapist
- •Person with venous thrombosis
- •Contraindications specific to the treatments studied
结局指标
主要结局
The main objective is to evaluate the effectiveness of TENS and TENS ECOMODYN® on the management of chronic breast pain after surgery.
时间窗: 16,5 months
Chronic pain is assessed using the Digital Pain Rating Scale (0 worse outcome to 10 better outcome) before and after using the method (TENS and TENS ECOMODYN®) at M0, M2, M2.5 and M4.5.
次要结局
- Evaluate the changes made by the treatment felt by the patient(16.5 months)