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CTRI Number  CTRI/2021/12/038734 [Registered on: 20/12/2021] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   MANAGEMENT OF CHRONIC MIGRAINE 
Scientific Title of Study   TRANSCRANIAL STIMULATION AND CRANIO- CERVICAL RELEASE TECHNIQUE FOR THE MANAGEMENT OF CHRONIC MIGRAINE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepti Agrawal Garg 
Designation  Assistant Professor 
Affiliation  Sri Aurobindo Institute of Medical Sciences 
Address  1607,Pinnacle Dreams,PT-1,, Pipliakumar,Nipania Road, Indore (M.P.)

Indore
MADHYA PRADESH
452010
India 
Phone  9179394871  
Fax    
Email  deepti.agrawal6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Chandra Patra  
Designation  Asso. Professor 
Affiliation  Lovely Professional University 
Address  Phagwara, Punjab

Jalandhar
PUNJAB
144411
India 
Phone  9653174563  
Fax    
Email  rameshpatra2208@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deepti Agrawal Garg 
Designation  Assistant Professor 
Affiliation  Sri Aurobindo Institute of Medical Sciences 
Address  1607,Pinnacle Dreams,PT-1,, Pipliakumar,Nipania Road, Indore (M.P.)

Indore
MADHYA PRADESH
452010
India 
Phone  9179394871  
Fax    
Email  deepti.agrawal6@gmail.com  
 
Source of Monetary or Material Support  
Sri Aurobindo Institute of Allied Health and Paramedical Sciences 
 
Primary Sponsor  
Name  Dr Ramesh Chandra Patra 
Address  Sri Aurobindo Institute of Allied Health and Paramedical Sciences 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand Misra  Sri Aurobindo Institute of Medical Sciences  Physiotherapy Department, Indore-Ujjain State Highway, Gram: Bhanwrasla,Tehsil: Sanwer Dist:Indore(M.P.) PIN- 453555
Indore
MADHYA PRADESH 		 9827242576

anand5556@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Aurobindo Institute of Alied Health & Paramedical Sciences(Institutional Ethics Committee)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G892||Chronic pain, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Migraine  Conventional Physiotherapy, 3 days in a week for 4 weeks 
Intervention  Physiotherapy   Conventional Physiotherapy, Brain Stimulaion & Manual Therapy. 3 days in a week for 4 weeks 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  17
4.3 Study Duration- 3 years
4.4 Treatment Duration- 3 times a week, for 4 weeks
4.5 Selection Criteria:
4.5.1 Inclusion Criteria-
Based on the following conditions the individuals are included in the study:
1. Both male and female with the age group of 20-50 years.
2. The diagnosis must meet the 2018 IHS criteria (30) for migraine without aura, migraine with aura, or chronic migraine;
3. The duration of the disease must be at least 12 months; 
 
ExclusionCriteria 
Details  Other primary headache types (e.g. cluster headache, short-lasting unilateral neuralgia form headache with conjunctival injection and tearing (SUNCT))
2. Secondary headache due to a pathology not located in the cervical spine.
3. Cervical spine injury, fracture or surgery.
4. Congenital spinal deformity.
5. The participants not meeting age criteria for inclusion. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
MIDAS
VAS
SF-36
Frequency of migraine attack
Duration of migraine
Intensity of migraine
Pressure pain threshold 		 before starting a treatment 
 
Secondary Outcome  
Outcome  TimePoints 
MIDAS
VAS
SF-36
Frequency of migraine attack
Duration of migraine
Intensity of migraine
pressure pain threshold 		 after 4 weeks of treatment 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/12/2021 
Date of Study Completion (India) 22/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 review article related to this study have been published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  can mail me at deepti.agrawal6@gmail.com

  6. For how long will this data be available start date provided 27-10-2021 and end date provided 31-12-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - once the data will be collected, will share soon.
Brief Summary   The study is going to perform on chronic migraine patients diagnosed via a neurologist. The patients will then be assessed on the basis of outcome measures before applying any treatment in both control group as well as in experimental group. Then will be reassess on the outcome measured quantitatively. All  the patients will be given some home based program along with dietary suggestions. 
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