| CTRI Number |
CTRI/2022/09/045950 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
20/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of exercises on industrial workers with neck pain. |
|
Scientific Title of Study
|
Effect Of Work-Based Exercise Program Among Industrial
Workers Having Non-specific Neck Pain Using ICF CORE SET:
A Pre-Post Experimental Study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Omkar Ghadi |
| Designation |
PG Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9686361659 |
| Fax |
|
| Email |
omkarghadi9686@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashant Naik |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
974323382 |
| Fax |
|
| Email |
mptnaik06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Omkar Ghadi |
| Designation |
PG Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9686361659 |
| Fax |
|
| Email |
omkarghadi9686@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and research center, Nehru Nagar, Belagavi. |
|
|
Primary Sponsor
|
| Name |
KAHER institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| omkar Ghadi |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Omkar Ghadi |
KAHER Institute of Physiotherapy |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka.
Belgaum
KARNATAKA |
9686361659
omkarghadi9686@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KAHER Iinstitute of Physiotherapy. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non specific neck pain. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
WORK BASED EXERCISE PROGRAM |
Subjects will be given Positional release Technique, Neuromuscular exercises, stretching exercise for a period of 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Industrial workers having non–specific neck pain,
2. The intensity between 3-6 on the Visual analog scale.
3. An individual engaged in prolonged walking, standing, a repetitive task such as lifting,
carrying pulling, and pushing heavy loads are included in the study.
4. Participants are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Diagnosed Neurological condition
Participants have pain secondary to trauma, spondylitis, and infection in the neck and
shoulder region.
2. Participants already undergoing treatment for pain before commencement of the
study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VISUAL ANALOGUE SCALE (VAS)
GONIOMETER for Range of motion assessment
RULA Scale
ICF Documentation Form |
Subjects will be assessed on 1st day pre-treatment and on the 14th day i.e. post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
30/09/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To Find The Effect Of Work-Based Exercise Program Among Industrial Workers Having Non-Specific Neck Pain. Neck Pain Will be Assessed Using a Visual Analog Scale, Neck Range Of Motion Will Be Assessed Using a Goniometer, RULA Scale Will Be Administered To Identify The Risk Of Non-Specific Neck Pain, And ICF Documentation Form Will Be Administered To Know Their Activity And Participation. Subjects will be given a Positional release technique for neck pain and a work-based exercise
program, the intervention will be provided in a span of 2 weeks for alternative days. Pre Assessment will be taken on day 1 and post-assessment will be taken on day 14 |