Repetitive Transcranial Magnetic Stimulation inPost-Mastectomy Pain Syndrome.

Phase 1

Recruiting

Conditions: Malignant neoplasm of breast of unspecified site,

Registration Number: CTRI/2023/10/058431

Lead Sponsor: AIIMS

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 40

Inclusion Criteria

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 â‰¥3 score in a visual analogue scale (VAS) of pain will be included.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the effect of repetitive transcranial magnetic stimulation on following aspects of post mastectomy pain syndrome:	Two: Baseline and 3 weeks
Pain status	Two: Baseline and 3 weeks
Quality of life	Two: Baseline and 3 weeks
Thermal thresholds	Two: Baseline and 3 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life

Trial Locations

Locations (1): All India Institute of Medical Science, New Delhi
🇮🇳
West, DELHI, India
All India Institute of Medical Science, New Delhi
🇮🇳West, DELHI, India
Renu Bhatia
Principal investigator
8860169671
renuaiims28@gmail.com