| CTRI Number |
CTRI/2024/04/065054 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Commonness of Musculoskeletal Disorders among Fisherwomen in Goa |
|
Scientific Title of Study
|
Prevalence of Musculoskeletal Disorders among Fisherwomen in Goa: A Cross Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alisha Gracias |
| Designation |
Assistant Professor in Physiotherapy |
| Affiliation |
Goa Medical College Bambolim Goa |
| Address |
Department of Orthopaedics
Priority Eros, UG 4
Behind Bhale Hospital
Near Porvorim Medical Store
Alto- Porvorim Goa
North Goa
GOA
403501
India |
| Phone |
9881887175 |
| Fax |
|
| Email |
Alisha.gracias@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alisha Gracias |
| Designation |
Assistant Professor in Physiotherapy |
| Affiliation |
Goa Medical College Bambolim Goa |
| Address |
Department of Orthopaedics
Priority Eros, UG 4
Behind Bhale Hospital
Near Porvorim Medical Store
Alto- Porvorim Goa
North Goa
GOA
403501
India |
| Phone |
9881887175 |
| Fax |
|
| Email |
Alisha.gracias@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alisha Gracias |
| Designation |
Assistant Professor in Physiotherapy |
| Affiliation |
Goa Medical College Bambolim Goa |
| Address |
Department of Orthopaedics
Priority Eros, UG 4
Behind Bhale Hospital
Near Porvorim Medical Store
Alto- Porvorim Goa
North Goa
GOA
403501
India |
| Phone |
9881887175 |
| Fax |
|
| Email |
Alisha.gracias@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College, Bambolim. |
|
|
Primary Sponsor
|
| Name |
Goa Medical College |
| Address |
Bambolim - Goa |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alisha Gracias |
Fish Market Panaji, Goa |
FRXC+VWV,
Unnamed Road-Panjim,
Altinho-Goa
403001
403001
North Goa
GOA |
9881887175
Alisha.gracias@gmail.com |
| Dr Alisha Gracias |
Margao Wholesale Fish market |
7XQ2+F59,
Madel, Majorda,
Margao-Goa
403708
South Goa
GOA |
9881887175
Alisha.gracias@gmail.com |
| Dr Alisha Gracias |
Ponda Fish Market |
C225+XG8,
Upper Bazar Road,
Antruj Nagar,
Ponda-Goa
403401
South Goa
GOA |
9881887175
Alisha.gracias@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College, Bambolim – Complex, Goa-403 202. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Musculoskeletal disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1) Women willing to participate.
2) Age: 45-65 years of age
3) Years of experience should be minimum 5 years
4) Working hours: 5-6 hours.
|
|
| ExclusionCriteria |
| Details |
1) Subjects with musculoskeletal conditions like recent fractures, neurological conditions, recent surgery.
2) Years of experience should not be less than 5 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Pain Chart |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Questionnaire |
5 years |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
Final Enrollment numbers achieved (Total)= "350"
Final Enrollment numbers achieved (India)="350" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/04/2024 |
| Date of Study Completion (India) |
30/06/2024 |
| 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
Modification(s)
|
Yet to be published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A pilot study with 30 participants was conducted to determine the feasibility of the study. A cross- sectional study was conducted by administering a structured questionnaire to a sample of 350 fisher-women, and the data was collected through a interview method from fisher women from major fish markets in Goa, including Panjim, Ponda and Margao. The study states that fisher-women in Goa are highly prone to musculoskeletal disorders. |