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CTRI Number  CTRI/2022/08/044726 [Registered on: 17/08/2022] Trial Registered Prospectively
Last Modified On: 12/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Trial To Find Risk Factors And Prevalance Of Shoulder Pain In Middle Age Women 
Scientific Title of Study   Risk Factors And Prevalance Of Shoulder Pain In Middle Age Women 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swetaben Gopal Mevasi 
Designation  MPT 1st Year 
Affiliation  College Of Physiotherapy,Sumandeep Vidyapeeth 
Address  PG Classrom,On Ground Floor, College Of Physiotherapy,Sumandeep Vidyapeeth, An Institution Deemed to be University, At And Post Pipariya,Taluka-Waghodiya,Vadodara Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9313633992  
Fax    
Email  mevasianila@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Niketa Patel 
Designation  Assistance Professor And Guide 
Affiliation  College of physiotherapy, Sumandeep Vidhyapeeth  
Address  Staff Room,On ground floor, college of physiotherapy, Sumandeep Vidyapeeth, An institution deemed to be university, At and post Pipariya Taluka-Waghodiya, Vadodara, Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9099774190  
Fax    
Email  niketa.cop@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query  
Name  Niketa Patel 
Designation  Assistance Professor And Guide 
Affiliation  College of physiotherapy, Sumandeep Vidhyapeeth  
Address  Staff Room,On ground floor, college of physiotherapy, Sumandeep Vidyapeeth, An institution deemed to be university, At and post Pipariya Taluka-Waghodiya, Vadodara, Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9099774190  
Fax    
Email  niketa.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
This is self funded study. The infrastructure is provided by Dhiraj General Hospital and from the community nearby Dhiraj General Hospital, at and post piparia, Taluka-Waghodia, Vadodara, Gujarat, India -391760 
 
Primary Sponsor  
Name  Mevasi Sweta Goaplbhai 
Address  College of physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed to be University, At and post Piparia, Taluka - waghodia, Vadodara, Gujarat, India-391760 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Swetaben Gopalbhai Mevasi  Dhiraj General Hospital  Physiotherapy opd,ground floor,and Sumandeep Vidyapeeth Campus At and post pipariya,Taluka Waghodia District vadodara Gujrat
Vadodara
GUJARAT 		 9313633992

mevasianila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M758||Other shoulder lesions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Middle aged women
Shoulder pain
Difficulty in shoulder functional activities
 
 
ExclusionCriteria 
Details  Unwillingness
Previous shoulder surgeries
Referred shoulder pain
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Nordic Musculoskeletal Questionnaire score
2.Shoulder Pain and Disability Index (SPADI) 		 1 time in the research study of 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   22/08/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
They will be explained about the study and those who are willing to participate will be requested to sign an informed consent (Annexure I). After signing the consent, Participant information sheet (Annexure II) will be given
1.The Nordic Group to develop a standardized questionnaire for the analysis of complaints in musculoskeletal. This questionnaire can be used to assess musculoskeletal disorders of different parts of the body in epidemiological studies.
2. The original version of the Shoulder Pain Disability Index (SPADI) is a quality-of-life questionnaire developed to evaluate the pain and disability associated with shoulder dysfunction. The SPADI is a 13-item shoulder function index on the ability of responders to carry out basic activities of daily living. Each item is scored by a numeric rating scale that ranges from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). SPADI provides a pain scale (5 items; scale score range 0–50 points, expressed as percentage) and a disability scale (8 items; scale score range 0 – 80 points, expressed as percentage)
 
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