Effectiveness of Mechanical Stimulation on Pain Level and Functional Discomfort Following a Total Mastectomy and Exploratory Axillary Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Mobility of the shoulders
研究概览
简要总结
This study evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months, in breast cancer needing physiotherapy, following a total mastectomy and exploratory axillary surgery.
详细描述
A prospective, monocentric, randomized, open-labelled in two parallel groups study that evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months in breast cancer patients needing physiotherapy, following a total mastectomy and exploratory axillary surgery.
Other objectives of the study include:
- Evaluate the efficacy of mechanical stimulation technique compared to massages on pain and functional discomfort (on the mobility of the shoulder) 15 days after the end of physiotherapy.
- Evaluate the impact of mechanical stimulation on the quality of life of patients, in comparison to those receiving massages
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patient who had total mastectomy for a breast cancer or pre-cancerous lesions
- •Associated with axillary dissection or removal of the sentinel lymph nodes
- •Presenting with functional discomfort and/or pain at the control consultation, 3 weeks after the mastectomy and justifying the prescription of physiotherapy
- •Possibility to be treated by a physiotherapist who can carry out both techniques and accepts to perform either one of the techniques according to the randomized allocation of the treatment
- •Patient covered by the French social security regime
- •Signed and informed consent
排除标准
- •Immediate breast reconstruction
- •Total bilateral mastectomy
- •Contraindication to mechanical stimulation technique
- •Patient who are planning to move houses in the next 6 months
- •Patients under guardianship
研究组 & 干预措施
Arm A - Mechanical Stimulation
Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation
干预措施: Mechanical Stimulation (Procedure)
Arm B - Massages
Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages.
干预措施: Massages (Procedure)
结局指标
主要结局
Mobility of the shoulders
时间窗: 6 months after randomization
Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4. Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.
Pain level by a numerical scale
时间窗: 6 months after randomization
Pain level will be evaluated using a numerical scale of pain
Pain level by using Brief Pain Inventory
时间窗: 6 months after randomization
Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Pain level by using QDN4 questionnaire
时间窗: 6 months after randomization
Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
次要结局
- Pain level by using Brief Pain Inventory(15 days after the end of physiotherapy)
- Pain level by a numerical scale(15 days after the end of physiotherapy)
- Pain level by using QDN4 questionnaire(15 days after the end of physiotherapy)
- Anxiety(at the baseline and 6 months after)
- Mobility of the shoulders(15 days after the end of physiotherapy)
- Quality of Life (QoL) with EORTC-QLQ-C30(at the baseline and 6 months after)
- Quality of Life (QoL) with EORTC-QLQ-BR23(at the baseline and 6 months after)