| CTRI Number |
CTRI/2023/10/059334 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
28/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Effect of Yoga and Physiotherapy for Computer Users: An Interventional Study |
|
Scientific Title of Study
|
Evaluating The Effect Of Yoga And Physiotherapy On Pain And Functional Disability In Computer Users With Mechanical Neck Pain : An Interventional 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 |
Hinal Bhatt |
| Designation |
Post Graduate Student |
| Affiliation |
RK University |
| Address |
Research Department, Room no. 207,School Of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot Gujarat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9106226765 |
| Fax |
|
| Email |
hbhatt121@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sojitra MPT |
| Designation |
Assistant Professor, School Of Physiotherapy, RK University |
| Affiliation |
RK University |
| Address |
Research Department room no. 207,School Of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9427110124 |
| Fax |
|
| Email |
namrata.sojitra@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Hinal Bhatt |
| Designation |
Post Graduate Student |
| Affiliation |
RK University |
| Address |
Research Department room no. 207,School Of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar, Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9106226765 |
| Fax |
|
| Email |
hbhatt121@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy RK University |
| Address |
School Of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar, Highway, Rajkot, Gujarat, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hinal Bhatt |
Computer Department, RK University |
1st Floor, Lab no. 1 to 12, Computer Department, School of Engineering, RK University
Rajkot
GUJARAT |
9106226765
hbhatt121@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, School Of Physiotherapy, RK University, Rajkot-Bhavnagar Highway Rajkot, 360020 Gujarat, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mechanical Neck Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physiotherapy |
Scapular Upward Rotation Exercise, Scapular Protraction, Scapular Retraction, Scapular Protraction With Scapulae Elevation, Scapular Retraction With Scapular Elevation, Neck Isometric Exercise, Chin Tuck, Trapezius Stretching |
| Intervention |
Yoga And Physiotherapy |
Group A Yoga (interventional study)
Greeva Sanchalana, Ardhmatsyendrasana, Makarasana
10 times each Yoga 1 session in a day, 5 days per week, for 4 weeks.
Group B Physiotherapy (control group)
Scapular Upward Rotation Exercise, Scapular Protraction, Scapular Retraction, Scapular Protraction With Scapulae Elevation, Scapular Retraction With Scapular Elevation, Neck Isometric Exercise, Chin Tuck
Following exercise will do 10 repetitions in 1 session in 1 day, 5 days a week, for 4 weeks.
Trapezius Stretching For 30 seconds hold for 3 sessions in a day for 5 days a week, for 4 week |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) age 25 to 45 years.
2) using a computer for >15 hours/week and >3 years.
3) posture-related mechanical neck pain.
4) mechanical neck pain with grades 1 and 2. |
|
| ExclusionCriteria |
| Details |
1) cervical disorders (vertebral artery insufficiency, neoplasm..).
2) neurological symptoms.
3) previous history of neck trauma and spondylosis, periarthritis, rheumatoid arthritis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale (NPRS)
Neck Disability Index (NDI) |
At base line day 1 and after completing of 4 weeks of interevntion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2023 |
| 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="3"
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
|
Title: Evaluating The Effect Of Yoga And Physiotherapy On Pain And Functional Disability In Computer Users With Mechanical Neck Pain: An Interventional Study
Introduction: Neck pain in computer users is directly related to the duration of a computer job. Physiotherapy and yoga are very helpful in reducing pain and stress relief. So this study is to show the effect of yoga and physiotherapy in computer users with mechanical neck pain.
Method: This is an intervention to analyze the effect of yoga and physiotherapy on computer users with mechanical neck pain. Subjects will be selected based on inclusion and exclusion criteria and written consent will be taken. Subjects will be assessed with outcome measures pre and post-intervention. Group A - Yoga And Physiotherapy Group B - Physiotherapy The intervention program will be for 4 weeks. |