Effect of Repetitive Transcranial Magnetic Stimulation on Pain and Quality of Life inPost-Mastectomy Pain Syndrome
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- AIIMS
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Quality of life
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
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 ≥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.
Outcomes
Primary Outcomes
Quality of life
Time Frame: Two: Baseline and 3 weeks
To study the effect of repetitive transcranial magnetic stimulation on following aspects of post mastectomy pain syndrome:
Time Frame: Two: Baseline and 3 weeks
Pain status
Time Frame: Two: Baseline and 3 weeks
Thermal thresholds
Time Frame: Two: Baseline and 3 weeks
Secondary Outcomes
- Quality of life