| CTRI Number |
CTRI/2024/02/062424 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Common bone and joint issues among food delivery riders |
|
Scientific Title of Study
|
Prevalence and Risk factors of Musculoskeletal Disorders among Food Delivery 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 |
Urusha Praween |
| Designation |
PG student |
| Affiliation |
Amity University Noida |
| Address |
Amity institute of health allied sciences Amity university Noida F-1 sector 125 Noida 201313
South
DELHI
201313
India |
| Phone |
9873423937 |
| Fax |
|
| Email |
urushapraveen555@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
UTTAR PRADESH
201301
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asad Manzoor |
| Designation |
H.O.D |
| Affiliation |
Amity University Noida |
| Address |
Amity institute of health allied sciences Amity university Noida F-1 LGF-03 sector 125 Noida 201313
South
DELHI
110025
India |
| Phone |
9910455008 |
| Fax |
|
| Email |
asad786manzoor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amity University Amity institute of health allied sciences |
| Health Plus Physiotherapy and Rehabilitation Center |
|
|
Primary Sponsor
|
| Name |
Amity Institute of health allied sciences |
| Address |
Amity university F-1 LGF-03 sector 125 Noida Uttar Pradesh |
| Type of Sponsor |
Other [Self Sponsor ] |
|
|
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 |
| Asad Manzoor |
Health Plus Physiotherapy and Rehabilitation Center |
Shaheen bagh 40 futa road Physiotherapy department ground floor room no.3
South
DELHI |
9910455008
asad786manzoor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amity University Noida |
Approved |
| Amity University Noida |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Musculoskeletal pain |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Male Subject
Age 18 – 45 years old Any Musculoskeletal Pain Like Joint pain, Muscle pain and Muscle Numbness,
Work Status, Full Time mote than 12 hours, Duration of Employment,less than 3 months, Food Delivery Rider from Community Center, NFC, New Delhi
|
|
| ExclusionCriteria |
| Details |
Traumatic Upper limb or Spinal injuries,Rotator Cuff Injury,
Individuals who have been previously diagnosed with a musculoskeletal disorder MSD Insufficient ride duration Employment less than 3 months
Non-Regular Riders or Part time riders
Lower limb Injuries Any Gastrointestinal, Cardiac, Respiratory condition
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence of Musculoskeletal Disorders within the different regions of the body among individual working as food delivery riders |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To investigate the risk factors of Musculoskeletal disorders among food delivery riders |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
17/02/2024 |
| 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="24"
Months="1"
Days="29" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The purpose of this study is to investigate the prevalence and risk factors of Musculoskeletal disorders among food delivery riders
METHODOLOGY: The study adopts a cross-sectional design to investigate musculoskeletal issues among male food delivery riders aged 18–45 in New Delhi. A sample size of 130 will be randomly selected, applying strict inclusion criteria such as full-time employment, a minimum of three months in the profession, and residence in the NFC Community Center area. Exclusion criteria encompass traumatic injuries, previous musculoskeletal diagnoses, and non-regular riders. Risk factors, including meal irregularity and vehicle type, will be assessed using the Nordic Musculoskeletal Questionnaire and Numeric Pain Rating Scale. Data analysis will employ binary logistic regression to identify trends and risk factors associated with musculoskeletal pain. The study aims to contribute valuable insights into the prevalence and causative factors of such issues, utilising a concise and targeted approach for data collection and analysis.
|