CTRI Number |
CTRI/2023/06/054027 [Registered on: 16/06/2023] Trial Registered Prospectively |
Last Modified On: |
12/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Problems in Musculoskeletal system in Women After Menopause |
Scientific Title of Study
|
Musculoskeletal Disorders in Postmenopausal Women |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Priyal shah |
Designation |
PG student |
Affiliation |
College of physiotherapy, Sumandeep Vidhyapeeth An Institute Deemed To Be University |
Address |
PG Classroom, On Ground Floor, College Of Physiotherapy,
Sumandeep Vidyapeeth, An Institution Deemed To Be University, At
And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat PG Classroom, On Ground Floor, College Of Physiotherapy,
Sumandeep Vidyapeeth, An Institution Deemed To Be University, At
And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat Vadodara GUJARAT 391760 India |
Phone |
9426490550 |
Fax |
|
Email |
priyalshah504@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrNeha Mukkamala |
Designation |
Associate Professor |
Affiliation |
College of physiotherapy, Sumandeep Vidhyapeeth An Institute Deemed To Be University |
Address |
Staff room,On Ground Floor, College Of Physiotherapy,
Sumandeep Vidyapeeth, An Institution Deemed To Be University, At
And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat Staff room, On Ground Floor, College Of Physiotherapy,
Sumandeep Vidyapeeth, An Institution Deemed To Be University, At
And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat Vadodara GUJARAT 391760 India |
Phone |
9898216184 |
Fax |
|
Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person Public Query
|
Name |
Priyal shah |
Designation |
PG student |
Affiliation |
College of physiotherapy, Sumandeep Vidhyapeeth An Institute Deemed To Be University |
Address |
PG Classroom, On Ground Floor, College Of Physiotherapy,
Sumandeep Vidyapeeth, An Institution Deemed To Be University, At
And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat PG Classroom, On Ground Floor, College Of Physiotherapy,
Sumandeep Vidyapeeth, An Institution Deemed To Be University, At
And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat Vadodara GUJARAT 391760 India |
Phone |
9426490550 |
Fax |
|
Email |
priyalshah504@gmail.com |
|
Source of Monetary or Material Support
|
This is a self funded study. The infrastructure is provided is by college of physiotherapy, sumandeep vidhyapeeth, An institutional deemend to be university vadodara gujarat |
|
Primary Sponsor
|
Name |
Priyal Shah |
Address |
PG Classroom, On Ground Floor, College Of Physiotherapy,
Sumandeep Vidyapeeth, An Institution Deemed To Be University, At
And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat |
Type of Sponsor |
Other [self] |
|
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 |
Priyal Shah |
Dhiraj general hospital |
1st floor,Gynecology department Dhiraj general hospital
sumandeep vidhyapeeth
pipariya vadodara
gujarat Vadodara GUJARAT |
9426490550
priyalshah504@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Dhiraj hospital |
No Objection Certificate |
Sumandeep vidyapeeth Institutional Ethics Committee (SVIEC) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
postmenopausal women |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Female |
Details |
All postmenopausal women (menopause for > 1 year) |
|
ExclusionCriteria |
Details |
1.women with unnatural menopause
2.women on medication such as anxiolytic and antidepresaant
3.women having mental retardation
4.women diagnosed with neurological disorders, metabolic disorders.
5.women diagnosed with malignancy
6.women hving musculoskeletal pain prior to menopause |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
cornell musculoskeletal discomfort questtionaire |
Baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="95" Sample Size from India="95"
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)
|
30/06/2023 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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
|
This is a observational study. In my study the postmenopausal women including in my inclusion criteria will be asseed and screened for the different musculoskeletal disorder. All the womens will be explained about the study in their own languge. They will be administered using cornell musculoskeletal discomfort questionnaire. Depending on the joint involvement they will be assesed in detail. |