跳至主要内容
临床试验/CTRI/2023/10/058431
CTRI/2023/10/058431招募中1 期

Effect of Repetitive Transcranial Magnetic Stimulation on Pain and Quality of Life inPost-Mastectomy Pain Syndrome

AIIMS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月10日最近更新:
适应症

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

研究者

发起方
AIIMS
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验