| CTRI Number |
CTRI/2021/10/037561 [Registered on: 26/10/2021] Trial Registered Prospectively |
| Last Modified On: |
17/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Influence of backache on educational engagement among occupational and physical therapy students in India |
|
Scientific Title of Study
|
Prevalence of low back pain amongst occupational therapy and physiotherapy students in India, its influence on educational engagement |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pham Ngoc Dat |
| Designation |
Master of Occupational Therapy in Hand and Musculoskeletal conditions |
| Affiliation |
Manipal College of Health Professional |
| Address |
Department of Occupational Therapy, 3rd floor, MCHP, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
8861243268 |
| Fax |
|
| Email |
pham.dat@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shovan Saha |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professional |
| Address |
Department of Occupational Therapy, 3rd floor, MCHP, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9880059426 |
| Fax |
|
| Email |
shovan.saha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pham Ngoc Dat |
| Designation |
Master of Occupational Therapy in Hand and Musculoskeletal conditions |
| Affiliation |
Manipal College of Health Professional |
| Address |
Department of Occupational Therapy, 3rd floor, MCHP, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
8861243268 |
| Fax |
|
| Email |
pham.dat@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pham Ngoc Dat |
| Address |
Department of Occupational Therapy, 3rd floor, MCHP, MAHE |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pham Ngoc Dat |
Kasturba Medical College and Kasturba Hospital |
Department of Occupational Therapy, 3rd floor, Manipal College of Health Professions, Manipal-576104, Karnataka,
Udupi
KARNATAKA |
8861243268
pham.dat@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Occupational therapy and Physiotherapy students from second to fourth year of bachelor course in universities in India.
2.Occupational therapy and Physiotherapy student during Internship in universities in India.
3.Occupational therapy and Physiotherapy in first and second-year master courses in universities in India.
4.Students will be included in the study if they were practicing in the clinical posting of their course (during the clinical phase, entails clinical placements, and exposure to clinical practice).
|
|
| ExclusionCriteria |
| Details |
Students who had undergone back surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Utrecht Work Engagement Scale short student version |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nordic Musculoskeletal Questionnaire |
Baseline |
| The subset of National College Health Assessment |
Baseline |
| Questions related clinical posting tasks |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
Final Enrollment numbers achieved (Total)= "321"
Final Enrollment numbers achieved (India)="321" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2021 |
| Date of Study Completion (India) |
27/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There is a
dearth of research examining the influence of low back pain on student’s
educational engagement. Literature on risk factors of low back pain is limited in relation to nature of occupational therapy and physiotherapy course in Indian context. Hence it is
vital to conduct the study which adds new knowledge to the existing literature on low
back pain and the risk factors associated with this health condition among
occupational therapy and physiotherapy students. Furthermore, it is essential to
identify the influence of low back pain on student’s educational engagement. So, this study will be conducted to investigate the prevalence and potential risk factors of low back pain amongst occupational therapy and
physiotherapy students in India and also its influence on educational engagement. |