| CTRI Number |
CTRI/2025/03/083450 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga on Neck pain and Poor Posture in ComputerĀ Workers |
|
Scientific Title of Study
|
Study of comprehensive yoga protocol on craneovertebral angle and neck disability among the computer operator |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Vijay |
| Designation |
Ph.D Scholar in Yoga |
| Affiliation |
Manipur University Canchipur Imphal Manipur India |
| Address |
Department of Yoga Manipur university Canchipur Imphal Manipur India
Imphal East MANIPUR 795003 India |
| Phone |
8839521569 |
| Fax |
|
| Email |
mamtavijay.phd.yoga@manipuruniv.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kuntal Ghosh |
| Designation |
Assistant Professor |
| Affiliation |
Manipur University Canchipur Imphal Manipur India |
| Address |
Department of Yoga Manipur university Canchipur Imphal Manipur India
Imphal East MANIPUR 795003 India |
| Phone |
9986847269 |
| Fax |
|
| Email |
ghosh.kun@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kuntal Ghosh |
| Designation |
Assistant Professor |
| Affiliation |
Manipur University Canchipur Imphal Manipur India |
| Address |
Department of Yoga Manipur university Canchipur Imphal Manipur India
Imphal East MANIPUR 795003 India |
| Phone |
9986847269 |
| Fax |
|
| Email |
ghosh.kun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Monetory support will be done by self and infrastructural support will be taken from Sir Sunderlal Hospital (SSH), I.M.S, B.H.U, Varanasi, Uttar Pradesh- 221005 |
|
|
Primary Sponsor
|
| Name |
Mamta Vijay |
| Address |
Department of Yoga Manipur University Canchipur Imphal Manipur India pin cod- 795003 |
| Type of Sponsor |
Other [Self Sponsure] |
|
|
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 Kuntal Ghosh |
Sir SundarLal Hospital, Banaras Hindu University |
Sir SundarLal Hospital, Banaras Hindu University Banaras Uttar Pradesh India pin cod -221005 Varanasi UTTAR PRADESH |
9986847269
ghosh.kun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instructional Human Ethics Committee, Manipur University, Canchipur-795003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control for 3 months |
No any yogic practices will be given for 3 months |
| Intervention |
Yogic practices for 3 months |
Sukhama vyayama, Asanas, Pranayama and meditation |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
2 Professional Computer Operator working in regular office hours with a average working hour 6 to 7 hours
4 Complain with Neck Pain
With neck pain vague numbness tingling or weakness in upper limbs
Limited range of movement Cervical stiffness reversible or irreversible dizziness and poor balance
|
|
| ExclusionCriteria |
| Details |
1. Recent cervical surgery or spinal fracture.
2. Neck pain due to inflammatory rheumatic diseases.
3. Congenital neck deformative.
4. Sever neck pain and restricted for neck movement.
5. The person who has suffering from severe diseases more than neck pain. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck Disability Index (NDI)
MB-Ruler Software |
10 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life (QoL) |
10 month |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
20/04/2025 |
| 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="1" Months="0" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - NILL
- For how long will this data be available start date provided 03-04-2025 and end date provided 12-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NILL
|
|
Brief Summary
|
The study evaluates the effectiveness of specific yoga modules on craniovertebral angle and neck disability in 90 cases with medically diagnosed neck pain It utilizes the Neck Disability Index NDI Quality of Life QoL Questionnaire and MB Ruler Software to assess improvements in pain intensity functional disability cervical range of motion and overall quality of life between control and experimental groups Measurements will be taken before and after the intervention for both groups |