| CTRI Number |
CTRI/2023/10/058431 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Repetitive transcranial magnetic stimulation] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Repetitive Transcranial Magnetic Stimulation in
Post-Mastectomy Pain Syndrome. |
|
Scientific Title of Study
|
Effect of Repetitive Transcranial Magnetic Stimulation on Pain and Quality of Life in
Post-Mastectomy Pain Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renu Bhatia |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
6007, 6th floor, convergence block, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
8860169671 |
| Fax |
|
| Email |
renuaiims28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Bhatia |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
6007, 6th floor, convergence block, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
8860169671 |
| Fax |
|
| Email |
renuaiims28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Kataria |
| Designation |
PG Student |
| Affiliation |
All India Institute of Medical Science |
| Address |
Pain Research and TMS Laboratory, 6th floor, Convergence block, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
8802383171 |
| Fax |
|
| Email |
monika.kataria1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar- 110029, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Renu Bhatia |
All India Institute of Medical Science, New Delhi |
6007, 6th floor, Department of Physiology, convergence block, AIIMS
South West
DELHI |
8860169671
renuaiims28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Repetitive Transcranial magnetic Stimulation (rTMS) |
It is a non-invasive, cortical stimulation approach that transmits magnetic fields through the scalp and skull, evoking electrical responses in cortical neurons.
rTMS would be given by Neurosoftâ„¢ï¸ Neuro MS/D TMS device by placing figure of eight coil (F8 coil) on contralateral motor cortex at an intensity of 80% of Resting Motor Threshold for each participant as per group allocation with each session containing 1200 pulses in 20 trains at 60 second inter-train interval with a frequency of 10 Hz. Total duration of the therapy will be 20-25 mins/day. rTMS therapy was given for 5 consecutive days for three weeks (total 15) sessions. |
| Comparator Agent |
Sham rTMS |
Same parameters as intervention but coil elevated and angled away from the head to produce subjective sensation of rTMS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of repetitive transcranial magnetic stimulation on following aspects of post mastectomy pain syndrome:
Pain status
Quality of life
Thermal thresholds
|
Two: Baseline and 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life
|
Two: Baseline & 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
07/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |