| CTRI Number |
CTRI/2016/10/007344 [Registered on: 06/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
14/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pain relieving strategies in chronic tension-type headache(CTTH) |
|
Scientific Title of Study
|
Effect of rTMS on central and peripheral pain modulation in chronic tension-type headache |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawna Mattoo |
| Designation |
junior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
room no. 2026,Department of Physiology,Academic Block
All India Institute of medical sciences(AIIMS)
room no. 2026,Department of Physiology,Academic Block
All India Institute of medical sciences(AIIMS)
South
DELHI
110029
India |
| Phone |
09717460911 |
| Fax |
|
| Email |
bhawnamattoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhawna Mattoo |
| Designation |
junior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
room no. 2026,Department of Physiology,Academic Block
All India Institute of medical sciences(AIIMS)
room no. 2026,Department of Physiology,Academic Block
All India Institute of medical sciences(AIIMS)
South
DELHI
110029
India |
| Phone |
09717460911 |
| Fax |
|
| Email |
bhawnamattoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu Bhatia |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr. Renu Bhatia, Assistant Professor, Dept. of Physiology, All India
Institute of Medical Sciences, Ansari Nagar
room no. 2026,Department of Physiology,Academic Block
All India Institute of medical sciences(AIIMS)
South
DELHI
110029
India |
| Phone |
01126596440 |
| Fax |
|
| Email |
renuaiims28@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| 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 |
| Dr Bhawna Mattoo |
Trascranial Magnetic Stimulation lab,Department of physiology |
All India Institute of
Medical Sciences,
Ansari Nagar, New
Delhi-110029
South
DELHI
South
DELHI |
01126549311
bhawnamattoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committtee,All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
chronic tension type headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Sucrose challenge test 2.
Repetitive transcranial magnetic
stimulation(rTMS) |
1. Sucrose 25 gm/100ml orally
pre and post rTMS (4 weeks); 2.
Non invasive transcranial
magnetic stimulation 1.0Hz for
30min/day for five consecutive
days/week) for 4 weeks
3.Patient will be followed up for
pain status and anxiety scores
for 6 months |
| Comparator Agent |
Healthy subjects; chronic tension type headache
subjects |
Normal healthy subjects
and Chronic tension type headache subjects with
age group between 18-50 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
This study is a randomized, parallel group, placebo controlled trial to study the effect of transcranial
magnetic stimulation on pain modulation status in chronic tension-type headache patients. Primary outcomes will be
subjective and objectives assessment of pain, biochemical analysis before and after rTMS therapywhich will be given for four weeks/five consecutive days/week. |
|
| ExclusionCriteria |
| Details |
Use of morphinomimetic drugs,Use of muscle relaxants H/o drug addiction H/o Hormonal therapy H/o vasodilator drugs H/o other pain relieving measure like yoga, acupuncture, acupressure etc. H/o ferromagnetic implants in head and neck regions, cardiac pacemakers H/o abnormal menstrual cycle, pregnancy, lactation
H/o seizure
H/o diabetes
H/o any peripheral neuropathy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Decrease in VAS Pain rating by 50%
2.Improvement decrease in LH level in response to sucrose
challenge test which is deranged in CTTH patients
3.The improvement nociceptive flexion reflex/R-III threshold |
The assessment will be done at the beginning of the treatment and after the completion of 20 days of rTMS therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain in CTTH is mediated by opioids
rTMS is effective therapy for treatment of CTTH
|
Outcome name:Oral sucrose challenge test,
25gm/100 ml, pre and post rTMS, Time points:6
months, 1 year
Outcome name: rTMS, 30 min/day/20 sessions,
Time points:4 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2015 |
| Date of Study Completion (India) |
30/11/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study is a randomized ,parallel group,placebo controlled trial to study the effect of transcranial magnetic stimulation on pain modulation status in chronic tension type headache patients.Primary outcomes will besubjective and objective assessment of pain,biochemical analysis before and after rTMS therapy which will be given for four consecutive weeks for five days a week. |