FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/11/060041 [Registered on: 20/11/2023] Trial Registered Prospectively
Last Modified On: 01/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Examining Cervical Spine in Migraine Patients at Tertiary Care hospital in Sikkim. 
Scientific Title of Study   A Study of Musculoskeletal Evaluation Of Cervical Spine Among Migraine Patient in Tertiary Care Hospital in Sikkim: A Cross-Sectional Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Siwani Agarwal 
Designation  Post Graduate. 
Affiliation  Sikkim Manipal University 
Address  Sikkim Manipal College Of Physiotherapy,5th Mile Tadong, East Sikkim.

East
SIKKIM
737102
India 
Phone  9851277747  
Fax    
Email  siwani_202204002@smims.smu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Prof.Nikita Joshi Sonowal 
Designation  Principal,Head of the department 
Affiliation  Sikkim Manipal University 
Address  Sikkim Manipal College Of Physiotherapy,5th Mile Tadong, East Sikkim.

East
SIKKIM
737102
India 
Phone  9932470754  
Fax    
Email  nikita.j@smims.smu.edu.in  
 
Details of Contact Person
Public Query  
Name  Siwani Agarwal 
Designation  Post Graduate. 
Affiliation  Sikkim Manipal University 
Address  Sikkim Manipal College Of Physiotherapy,5th Mile Tadong, East Sikkim.

East
SIKKIM
737102
India 
Phone  9851277747  
Fax    
Email  siwani_202204002@smims.smu.edu.in  
 
Source of Monetary or Material Support  
Central Referral Hospital,Sikkim Manipal University, Gangtok, East Sikkim, 737102, India 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Siwani Agarwal  Central Referral Hospital  Central Referral Hospital, Sikkim Manipal University, Gangtok, East Sikkim
East
SIKKIM 		 9064030395

siwani_202204002@smims.smu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMIMS INSTITUTION ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R51||Headache,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Age:18 years and above.
2.All genders.
3.Patient classified under IHS classification.
4.Patient taking medications/without medication.

 
 
ExclusionCriteria 
Details  1.Any other types of headaches (tension type headache, cervicogenic headache, medication overuse headache) etc.
2.Diagnosed pathology in the cervical spine (e.g., disc disease)
3.History of trauma to the head or neck (e.g., whiplash associated disorder)
4.Other musculoskeletal, neurological, or psychiatric disease
5.Participant refused to give consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Migraine Disability Index(MIDAS)
2.Neck Disability Index(NDI) 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   20/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is the study of Musculoskeletal Evaluation of Cervical Spine In Migraine patient in a tertiary care hospital in Sikkim. In this study Migraine Patient will be selected on the basic of IHS criteria (ICHD-2 CRITERIA).The referred case will be screened for the fulfilment of eligibility criteria. Participant Information Sheet will be provided and signed Informed consent will be obtained before collecting data. The assessment duration will take about 30 minutes. The descriptive data including age, gender, occupation, Duration of Migraine, Stages, contextual factors, and complaints will be recorded. The Musculoskeletal Evaluation of cervical spine in migraine patients will be done using Universal Goniometer for checking range of motion(ROM), Pressure Algometer to check pain pressure threshold, Plumb line to assess posture, and the outcome measure which will be used are MIDAS and NDI. Further data will be collected and Analysed.

Through skillful evaluation for cervical musculoskeletal impairment, a detailed treatment can be introduced which will help in a comprehensive management of migraine patients and improvise the treatment outcomes in near future.

 
Close