| CTRI Number |
CTRI/2024/03/064738 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence And Factors Of Risk In Low Back Pain Among Laboratory Students |
|
Scientific Title of Study
|
Prevalence And Risk Factors In Low Back Pain Among Laboratory Students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dawood Mustafa |
| Designation |
Post Graduate Student |
| Affiliation |
Amity University Noida UP |
| Address |
New Delhi Okhla Vihar Jamia Nagar near iqbal faizy hospital lane no 3 house no b26/7 2nd floor
Amity University Noida sector 125 Uttar Pradesh 201301 Gautam Buddha Nagar . Amity Institute Of Health Allied Sciences F1 Block
South
DELHI
110025
India |
| Phone |
9682615109 |
| Fax |
0 |
| Email |
dawoodmustafa130@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anu Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Amity University Noida |
| Address |
Amity University Noida sector 125 Uttar Pradesh 201301 Gautam Buddha Nagar . Amity Institute Of Health Allied Sciences F1 Block 1st floor , Faculty Cabin Area Room number 107 A
Amity University Noida sector 125 Uttar Pradesh 201301 Gautam Buddha Nagar Amity Institute Of Health Allied Sciences F1 Block 1st floor , Faculty Cabin Area Room number 107 A
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999620738 |
| Fax |
0 |
| Email |
abansal@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anu Bansal |
| Designation |
Assistant Professor III |
| Affiliation |
Amity Institute Of Health Allied Sciences |
| Address |
Amity University Noida sector 125 Uttar Pradesh 201301 Gautam Buddha Nagar . Amity Institute Of Health Allied Sciences F1 Block 1st floor , Faculty Cabin Area Room number 107 A
Amity University Noida sector 125 Uttar Pradesh 201301 Gautam Buddha Nagar . Amity Institute Of Health Allied Sciences F1 Block 1st floor , Faculty Cabin Area Room number 107 A
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999620738 |
| Fax |
0 |
| Email |
abansal@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity University Noida , sector 125 ,Noida, Uttar Pradesh 201301 |
|
|
Primary Sponsor
|
| Name |
Dawood Mustafa |
| Address |
Amity University Noida |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dawood Mustafa |
Amity University Noida |
Amity University Noida Uttar Pradesh Sector 125 Gautam Buddha Nagar 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9682615109
0
dawoodmustafa130@gmail.com |
| Dawood Mustafa |
New India Physiotherapy and Rehabilitation Centre |
-Basement Plot 4, SUPERTECH EMERALD COURT, Sector 93A, Noida, Uttar Pradesh-201305.
Gautam Buddha Nagar
UTTAR PRADESH |
9682615109
0
dawoodmustafa130@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh |
Approved |
| New India Physiotherapy and Rehabilitation Centre |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Low Back Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Laboratory Students
2.Age from 18 to 30 years
Students who are currently experiencing low back pain as well as those who are not
4.Non traumatic injuries
5.Male and Female Population
6.Willing to participate
7.Students who spend atleast 10 hours a week in laboratory
|
|
| ExclusionCriteria |
| Details |
1. Students who don’t fall in given age bracket
2. Non laboratory Students
3. Any history of trauma
4. History of surgery
5. Any Musculoskeletal disorder
6.Neurological deficits
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To determine the prevalence of LBP among laboratory students.
2)To gather information regarding frequency and severity of LBP.
3)To identify risk factors and characterize potential risk factors associated with low back pain among laboratory students |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : Studying risk factors for low back pain (LBP) among laboratory students which can provide valuable insights into the potential causes and risks associated with it |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
30/03/2024 |
| 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="2"
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
|
Low Back Pain is considered as one of the most incapacitating medical conditions, low back pain (LBP) is characterized by pain and discomfort above the inferior gluteal folds and below the costal margin, sometimes accompanied by leg pain. LBP is a well-recognized and extensively studied musculoskeletal disorder. Low back pain (LBP) is a common medical condition affecting individuals of all ages, from young children to the elderly, According to estimates, 50% to 80% of people will suffer from low back pain (LBP) at some point in their lives. The Global Burden of Disease conducted a study in 2019 and had found that there were approximately 223.5 million cases. The risk factors in LBP includes decreased flexibility of muscles and mobility, carrying and transporting heavy weights postural habits having a bad posture, having increased level of physical activity type of sports activity and cigarette smoking as well. Other factors are domestic factors which includes watching TV and staying on desktop for prolonged period of time. ). Laboratory tasks frequently necessitate repetitive, precise task execution and also postures that are static, sustained, and awkward. There may be increased risk of injury to low back due to micro trauma caused by pipetting, microscopy , working with biosafety cabinets and micromanipulation. A study was carried out in India and Iran on the Prevalence of laboratory work-related musculoskeletal problems and it was reported that the range was between 72% and 100% in Iran and India, and the lower back beign the most impacted area, accounting for 80% of all injuries.The aim of this study is to investigate the risk factors associated with the occurrence of low back pain (LBP) among laboratory students and prevalence also. The tools used are self adminstered questionnaire which participants wil fill and will be recorded and then data analysis will be done accordingly . |