| CTRI Number |
CTRI/2025/03/082989 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of Poor Posture on Cervical Spine an Observational Study on Structural Changes |
|
Scientific Title of Study
|
An Observational Study Of Structural Change In Cervical Vertebrae Due To Inappropriate Postural Behaviour |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Lohiya |
| Designation |
Pg Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurveda University, Haridwar |
| Address |
P.G. Department of Rachana Sharir, Anatomy Hall, Rishikul Campus, Haridwar
Uttarakhand
249401
Hardwar UTTARANCHAL 249401 India |
| Phone |
7456968067 |
| Fax |
|
| Email |
lohiyagarima05@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Naresh Kumar |
| Designation |
Professor (Head Of Department) |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurveda University, Haridwar |
| Address |
P.G. Department of Rachana Sharir, Anatomy Hall, Rishikul Campus, Haridwar
Hardwar UTTARANCHAL 249401 India |
| Phone |
9837352202 |
| Fax |
|
| Email |
drnaresh2266@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Naresh Kumar |
| Designation |
Professor (Head Of Department) |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurveda University, Haridwar |
| Address |
P.G. Department of Rachana Sharir, Anatomy Hall, Rishikul Campus, Haridwar
Hardwar UTTARANCHAL 249401 India |
| Phone |
9837352202 |
| Fax |
|
| Email |
drnaresh2266@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rachana Sharir Department, Rishikul Campus, Uttarakhand Ayurveda University, Haridwar, Uttarakhand
249401 |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus , Uttarakhand Ayurveda University, Haridwar |
| Address |
Rishikul Campus, Uttarakhand Ayurveda University, Haridwar
District- Haridwar
State- Uttarakhand
Pin Code-249401 |
| Type of Sponsor |
Government medical college |
|
|
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 Garima Lohiya |
Rishikul Campus, UAU, Haridwar |
Department of Rachana Sharir, Rishikul Campus, Uttarakhand Ayurveda University, Haridwar Uttarakhand Hardwar UTTARANCHAL |
7456968067
lohiyagarima05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Uttarakhand Ayurveda University, Rishikul Campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
age group 25-60yrs |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | nil | nil |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Volunteer / Case selection will be irrespective of gender, religion, education .
2) Volunteer age between 25-60 yrs.
3) Volunteer having inappropriate postural habitual tendency of at least 3 yrs.
4) Volunteer having 6-8 hours daily inappropriate posturing.
5) Volunteer willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Person having traumatic injuries, infections of cervical spine.
2) Person suffering from rheumatoid arthritis, ankylosing spondylitis.
3) Person having congenital structural deformities of cervical spine.
4) Person who have previously undergone cervical spinal surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the following-
1.pain in neck
2.restricted neck movement
3.stiffness
4.radiation of pain
5.numbness |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. X-ray of cervical spine
2. Goniometry |
1-2 days |
|
|
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)
|
20/03/2025 |
| 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="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Ayurveda and contemporary anatomy describe the cervical spine as an essential structure supporting the head and facilitating movement, and the study focuses on the structural changes in the cervical vertebrae brought on by poor postural habits. Postural deformities like "text neck" or "tech neck," which cause neck pain and cervical spondylosis, have increased due to modern lifestyle changes, including prolonged use of digital devices. The purpose of the study is to compare Ayurvedic and contemporary anatomical views of the cervical spine by radiographic analysis, survey-based research, and cadaveric dissection. Participants in this observational research must be between the ages of 25yrs and 60yrs and have had bad posture for at least three years. Objective X-ray evaluations and subjective pain measures are examples of assessments. The results will provide light on the structural alterations brought on by extended poor posture, assisting in the development of cervical health prevention and treatment strategies. According to the research, maintaining good posture is crucial for preventing long-term spine problems and enhancing general health. |