| CTRI Number |
CTRI/2024/05/067138 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Developing a Cognitive Assessment Tool for Cervicogenic Headache Patients |
|
Scientific Title of Study
|
DEVELOPMENT AND VALIDATION OF A COMPREHENSIVE COGNITIVE ASSESSMENT QUESTIONNAIRE FOR CERVICOGENIC HEADACHE PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayantika |
| Designation |
PG student |
| Affiliation |
Dr. D.Y Patil College of Physiotherapy |
| Address |
Room number-1,Department of musculoskeletal physiotherapy, 3rd floor
Dr.D.Y Patil College of Physiotherapy, Sant Tukaram Nagar,Pimpri Colony, Pimpri- Chinchwad, Maharashtra Pune
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9560181892 |
| Fax |
|
| Email |
jayantika.bhardwaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Saini |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y Patil College of Physiotherapy |
| Address |
Room number-1,Department of musculoskeletal physiotherapy, 3rd floor
Dr.D.Y Patil College of Physiotherapy, Sant Tukaram Nagar,Pimpri Colony, Pimpri- Chinchwad, Maharashtra Pune
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seema.saini@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Saini |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y Patil College of Physiotherapy |
| Address |
Room number-1,Department of musculoskeletal physiotherapy, 3rd floor
Dr.D.Y Patil College of Physiotherapy, Sant Tukaram Nagar,Pimpri Colony, Pimpri- Chinchwad, Maharashtra Pune
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seema.saini@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y Patil college of Physiotherapy, Sant Tukaram Nagar, Pimpri colony, Pimpri- Chinchwad, Pune,411018 |
|
|
Primary Sponsor
|
| Name |
Jayantika Bhardwaj |
| Address |
Dr. D.Y Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra, India 411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jayantika Bhardwaj |
Dr. D.Y Patil, Pune |
Room number-1,Department of
Musculoskeletal Physiotherapy, 3rd floor DR. D.Y Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA |
9560181892
jayantika.bhardwaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Dr. D.Y. Patil College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed with cervicogenic headache (IHS, CGH diagnostic criteria)
Participants between the age of 18-60 years.
Willingness to participate in this study.
|
|
| ExclusionCriteria |
| Details |
Individuals with coexisting neurological conditions (e.g., migraine, epilepsy) that may confound CGH-related cognitive assessments.
Those with a history of traumatic brain injury or neurodegenerative diseases.
Participants with any coexisting psychological disorders.
Recent fracture of cervical vertebrae.
Congenital conditions of cervical spine.
If they have received a medical procedure for pain relief (such as myofascial trigger point injection, or denervation procedure) within the last three months.
Participants who are unable to provide informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| development and validation of a comprehensive cognitive assessment questionnaire for cervicogenic headache patients |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "125"
Final Enrollment numbers achieved (India)="125" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
16/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
in process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: Development and validation of a comprehensive cognitive assessment questionnaire explicitly tailored for individuals suffering from cervicogenic headache (CGH).
Objective: To develop the comprehensive cognitive assessment questionnaire and to check its reliability and validity.
Need for study: Individuals with CGH demonstrate poorer cognitive abilities which led to lower quality of life. So limited attention is given to the cognitive aspect in CGH and there is a lack of specialized cognitive assessment tool for CGH patients.This tool can facilitate patient-centered care by identifying cognitive needs and personalized treatment plans.
Delphi method will be used in which there are two phases of the study. In phase 1 questionnaire will be developed with the help of an expert panel with a minimum 5 years of clinical experience and questions will be refined and finalized. In phase 2 of the study validity and reliability will be checked of the questionnaire on patients with cervicogenic headache
|