| CTRI Number |
CTRI/2024/08/072920 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Spinal and determinants among young bike riders |
|
Scientific Title of Study
|
Prevalence of spinal pain and associated risk factors among Young bike riders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jona Edward Rajan |
| Designation |
Bachelor student |
| Affiliation |
SRM Medical college hospital and research centre |
| Address |
SRM College of Physiotherapy Room no 5 Fifth floor SRM Medical college building SRM Institute of Science and Technology Kattankulathur Tamil Nadu 603203 India
Chennai
TAMIL NADU
603203
India |
| Phone |
6380393338 |
| Fax |
|
| Email |
jonajoe712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balamurugan Janakiraman |
| Designation |
Research Associate |
| Affiliation |
SRM College of Physiotherapy SRM Institute of Science and Technology |
| Address |
SRM College of Physiotherapy Room no 5 Fifth floor SRM Medical college building SRM Institute of Science and Technology Kattankulathur Tamil Nadu 603203 India
Chennai
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balamurugan Janakiraman |
| Designation |
Research Associate |
| Affiliation |
SRM College of Physiotherapy SRM Institute of Science and Technology |
| Address |
SRM College of Physiotherapy Room no 5 Fifth floor SRM Medical college building SRM Institute of Science and Technology Kattankulathur Tamil Nadu 603203 India
Chennai
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy SRM Institute of Science and Technology pillayar koil street SRM nagar Kattankulathur Tamil nadu India 603203 |
|
|
Primary Sponsor
|
| Name |
SRM College of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room no 1 SRM Medical college building SRM Institute of Science and Technology Kattankulathur Tamil Nadu 603203 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 Balamurugan Janakiraman |
SRM Institute of Science and Technology SRMIST Kattankulathur campus |
KTR campus Department of Physiotherapy
SRM College od Physiotherapy
Pillayar kovil street
Potheri
SRM Nagar
Kattankulathur
Tamil Nadu
603203
India
Chennai
TAMIL NADU |
9941215503
bala77physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young bike riders aged between 18 to 25 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Bike riders aged between 18 and 25 years of both genders and riding bike for more than one year |
|
| ExclusionCriteria |
| Details |
Recent injuries
Congenital musculoskeletal or neurological disorders
Any known musculoskeletal disorders or deformities
Riding bike for less than one year
Non resident Indians
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nordic questionnaire for pain |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue scale |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="422"
Sample Size from India="422"
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)
|
04/09/2024 |
| 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 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
|
Spinal pain is a leading problem in bike riders and is increasing day by day during and after bike riding. Spinal region refers to cervical spine, upper thoracic spine, middle thoracic spine, lumbar spine, coccyx & sacrum. By considering these regions, the spinal pain is evaluated in this particular study. Prevalence of Low Back Pain in Bike Ridersâ€. A Cross Sectional study done by Sultan, Muhammad Atta , et al. ( 2022 ) conducted an cross - sectional study among 200 bike riders. They concluded that 52% bike riders had low back pain. The primary objective of this study is to determine the prevalence of self-reported spinal pain among young bike riders and in addition the secondary objective is to find out the factors associated with the spinal pain. Methods An observational cross-sectional study will be designed to collect a sample of 422 young bike riders using systematic random sampling from the sequence of entry into the bike stands at the University premises. To allow temporal spread data collection will be limited 55 per day until the required data is collected. l A structured questionnaire will be used. l The questionnaire contains socio-demographic, measurements, riding behavior, bike information. l measurements [ Height , Weight] Outcomes Nordic pain questionnaire and Visual Analogue Scale (VAS 0 - 10 scale) TOOLS : l Standiometer l Weighing scale |