Effect of Repetitive Transcranial Magnetic Stimulation on Pain and Quality of Life inPost-Mastectomy Pain Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- AIIMS
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
This is a double blind, randomized control trial. Aim is to study the effect of repetitive transcranial magnetic stimulation on pain and quality of life in post-mastectomy pain syndrome. Objective is to study the effect of repetitive transcranial magnetic stimulation on Pain status, Quality of life and Thermal thresholds in post mastectomy pain syndrome. Participants will be referred from Department of Onco-Anaesthesiology and Palliative Medicine, BRA IRCH, AIIMS, New Delhi after a thorough check-up by the clinicians in the mentioned departments. All testing will be performed at Pain Research Laboratory (PRL), Room 6007, Department of Physiology, All India Institute of Medical Sciences, New Delhi. Patients will be randomly allocated in to two groups only after obtaining Ethical approval. Subjective assessment, objective assessment and intervention will be done as per protocol. Data/ results will be analysed and compared to assess any possible change in the pain status and quality of life. This study will have significance for health professionals and researchers involved in the management of post mastectomy pain syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women aged between 18 years to 65 years, who have had undergone modified radical mastectomy and whose surgery took place at least three months prior having ≥3 score in a visual analogue scale (VAS) of pain will be included.
排除标准
- •patients having Cardiac pacemaker, Metal Implants, Neuropsychiatric disorders, H/O Epilepsy, brain surgery, head injury Local or distant metastases or any other type of cancer and Any other chronic pain condition than PMPS will be excluded.
结局指标
主要结局
Quality of life
时间窗: Two: Baseline and 3 weeks
To study the effect of repetitive transcranial magnetic stimulation on following aspects of post mastectomy pain syndrome:
时间窗: Two: Baseline and 3 weeks
Pain status
时间窗: Two: Baseline and 3 weeks
Thermal thresholds
时间窗: Two: Baseline and 3 weeks
次要结局
- Quality of life
