| CTRI Number |
CTRI/2023/01/048833 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
07/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Identification of factors Associated with Non specific low back pain among lawyer. |
|
Scientific Title of Study
|
Identification of factors associated with non specific low back pain among lawyers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerna Mahto |
| Designation |
Student |
| Affiliation |
Amity Institute of physiotherapy |
| Address |
Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9871221898 |
| Fax |
|
| Email |
prerna.mahto@s.amity.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of physiotherapy |
| Address |
Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of physiotherapy |
| Address |
Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute Of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Madhumani Dubey |
Pro Hands Physiotherapy Clinic |
SD- 22, Sadarpur, Sector-45, Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9354114400
prohandsphysiotherapy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee |
Approved |
| Pro Hands Physiotherapy Clini |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants with age group 24-40 years.
Only Practicing Lawyers from past 1 year and onwards.
Frequent or continuous nonspecific Back pain.
Both males and females included.
|
|
| ExclusionCriteria |
| Details |
•Any previous illness and/or injuries that might have contributed to LBP
Female subjects who are pregnant
History of PIVD
History of Spinal Tuberculosis
History of Surgery of spine
History past slipping/fall history. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. DASS 21- Depression Anxiety Stress Scales
2. ODI- Oswestry Disability Index
3. IPAQ Questionnaire- International Physical Activity Questionnaire |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Body mass index
2. VAS- Visual Analog Scale
3. Lumbar Spine And Hip Range Of Motion assessment With goniometer.
4. CSR Test- Chair Sit And Reach Test
5. Half Sit And Up Test
6. REBA- Rapid Entire Body Assessment |
40 minutes |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
12/01/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a cross-sectional study to identify the factors associated with non specific low back pain among lawyers. The main objectives of the study is: To determine the Prevalence of non specific low back pain in lawyers. To determine association of factors (individual, physical, psychological, lifestyle, workplace) with non specific low back pain among lawyers. Practicing lawyers from past one year and onwards are taken in the study based on inclusion and exclusion criteria and ask to fill questionnaires and assessment is done using certain physical test and then the analysis will be done which factors are associated with non specific low back pain among lawyer. |