| CTRI Number |
CTRI/2024/07/070370 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between BMI and Critical Shoulder Angle in People with shoulder pain |
|
Scientific Title of Study
|
Relationship between body mass index and Critical Shoulder Angle in subjects with shoulder pain 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 |
Arya Pai Fondekar |
| Designation |
PG Student |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore-575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7720881143 |
| Fax |
|
| Email |
arya.mchpmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Charu Eapen |
| Designation |
MPT,ph.D. professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education-576104
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Charu Eapen |
| Designation |
MPT,ph.D. professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education-576104
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Kasturba Medical College, Mangalore 575004 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Charu Eapen |
KMC Hospital Ambedkar Circle |
Department of Physiotherapy, 5th floor, Dr. B.R. Ambedkar Circle, Hampankatta, Mangaluru, Karnataka, 575001
Dakshina Kannada
KARNATAKA |
9986024551
charu.eapen@manipal.edu |
| Dr Charu Eapen |
KMC hospital Attavar |
Department of physiotherapy, 2nd floor, Nandigudda road Mangaluru, Karnataka-575002.
Dakshina Kannada
KARNATAKA |
9986024551
charu.eapen@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients of 18 to 65 years of age with shoulder pain |
|
| ExclusionCriteria |
| Details |
humeral head and glenoid malunion, glenoid hypoplasia, humeral dysplasia, recurrent subluxation and dislocation, any nerve pathology related to shoulder joint |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. SPADI - to assess pain and difficulty level
2. Visual analogue scale- to assess pain
3.Body mass index
4. waist to hip ratio
5. body fat percentage |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Aim of the study to find association between the body mass index, waist to hip ratio , body fat percentage and critical shoulder angle in subjects with shoulder pain as there are no studies done in this area. If association is found then proper preventive measures should be taken in order to prevent further shoulder damage. |