| CTRI Number |
CTRI/2023/08/056499 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
02/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparision between the effect of Kinesio Taping versus Postural Correction Exercises on Pain , Disability and Posture in Computer Operator with Forward Neck Posture. |
|
Scientific Title of Study
|
The effect of Kinesio Taping versus Postural Correction Exercises on Pain, Disability and Posture in Computer Operator with Forward Neck Posture- A comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayuri Zoting |
| Designation |
Postgraduate |
| Affiliation |
Ravi Nair Physiotherapy College Wardha Maharashtra India 442001 |
| Address |
Datta Megha Institute of higher education and Research Ravi Nair Physiotherapy College Wardha Maharashtra India
Datta Megha Institute of higher education and Research Ravi Nair Physiotherapy College Wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284079262 |
| Fax |
|
| Email |
mayurizoting98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Patil |
| Designation |
Professor & HOD |
| Affiliation |
Ravi Nair Physiotherapy College Wardha Maharashtra India 442001 |
| Address |
Ravi Nair Physiotherapy College Wardha Maharashtra India
Ravi Nair Physiotherapy College Wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7709409637 |
| Fax |
|
| Email |
shubhangipatil148@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Mayuri Zoting |
| Designation |
Postgraduate |
| Affiliation |
Ravi Nair Physiotherapy College Wardha Maharashtra India 442001 |
| Address |
Datta Megha Institute of higher education and Research Ravi Nair Physiotherapy College Wardha Maharashtra India
Datta Megha Institute of higher education and Research Ravi Nair Physiotherapy College Wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284079262 |
| Fax |
|
| Email |
mayurizoting98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Community Health Physiotherapy Ravi Nair Physiotherapy College Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Research Cell of Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research |
| 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 |
| Mayuri Zoting |
Datta Megha Institute of higher education and Research |
Ravi Nair Physiotherapy College Wardha in Community Health Physiotherapy Department
Wardha
MAHARASHTRA |
9284079262
mayurizoting98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio taping |
There will be total 90 Computer operators with forward neck posture will be taken into the study There will be 45 participants in each group Group A will be receiving Postural correction
and Group B will be receiving Kinesio taping |
| Comparator Agent |
Postural Correction Exercise |
There will be total 90 Computer operators with forward neck posture will be taken into the study There will be 45 participants in each group Group A will be receiving Postural correction and Group B will be receiving Kinesio taping |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. The computer operator with a forward head posture
2. The computer operator works in the same position daily for 6 to 8 hours.
3. pain on a Numeric pain rating scale of more than five. |
|
| ExclusionCriteria |
| Details |
1. Any skin condition like dermatitis, eczema, and other infectious diseases.
2. Any neck injury or operative surgeries performed on the cervical spine.
3. Any deformity or fracture of the cervical spine.
4. cervical radiculopathy. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Cervical curvature
Cervical Range Of Motion |
Visual Analogue Scale
Cervical curvature first baseline score will be taken and then after 4 weeks
Cervical Range of motion first baseline score will be taken and then after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck Pain Disability Index |
Neck Pain Disability Index first baseline score will be taking and then after 4 weeks |
|
|
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)
|
30/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/08/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="20" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Analytic Code
- 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 - Proposals should be directed to [mayurizoting98@gmail.com].
- For how long will this data be available start date provided 28-04-2024 and end date provided 28-04-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
Many studies proved that physiotherapy interventions may be beneficial for neck pain; however, these studies are conducted on a specific condition component such as pain without considering the posture or were limited to subcomponents of intervention such as therapeutic exercises. Furthermore, there is a dearth of information on the implementation of interventions. To add to the existing knowledge pool and provide comprehensive and up-to-date evidence of the effectiveness of postural correction exercises and taping techniques on pain, disability, and posture in computer operators with forward head posture, this study has been proposed. The objectives of the study are to find out the effect of postural correction exercises and Kinesio taping on pain in computer operators with forward head posture using a Visual Analog Scale followed by that to find out the effect of postural correction exercises and Kinesio taping on neck disability in computer operators with forward head posture using neck disability index. Also, use a Craniovertebral angle to find out the effect of postural correction exercises and Kinesio taping on posture in computer operators with forward neck posture. and to compare the effect of postural correction exercises and Kinesio taping on posture in computer operators with forward neck posture by using a Craniovertebral angle. The Hypothesis says there will be a statistical significance or no significance between the effect of postural correction exercises and Kinesio taping on pain, disability, and posture in computer operators with forward neck posture.
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