| CTRI Number |
CTRI/2025/07/092053 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation of SPADI into Kannada and analyzing its properties |
|
Scientific Title of Study
|
Translation of Shoulder Pain and Disability Index in Kannada language and analysis of its psychometric properties in persons with Adhesive Capsulitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaya P |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller College of Physiotherapy,
Kankanady, Managalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9611057292 |
| Fax |
|
| Email |
jayakulal55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saumya Srivastava |
| Designation |
Associate Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Deralakatte, Managalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7007337186 |
| Fax |
|
| Email |
saumyasri2000@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saumya Srivastava |
| Designation |
Associate Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Deralakatte, Managalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7007337186 |
| Fax |
|
| Email |
saumyasri2000@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital, Fr Muller Road, Kankanady, Mangalore-575002 |
|
|
Primary Sponsor
|
| Name |
Father Muller Medical College Hospital |
| Address |
Kankanady, Mangalore-575002 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Jaya P |
Father Muller Medical College Hospital |
Department of Physiotherapy, FMMCH, Fr Muller road, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA |
9611057292
jayakulal55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Frozen shoulder patients |
|
| ExclusionCriteria |
| Details |
any other patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Function SPADI |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
25/08/2025 |
| 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 Yet Recruiting |
| 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
|
The
proposed study aims to translate the Shoulder Pain and Disability Index (SPADI)
into Kannada and evaluate its psychometric properties in individuals with
Adhesive Capsulitis. Given the high prevalence of shoulder disorders and the
significant impact they have on daily functioning, a validated, culturally appropriate
assessment tool is essential for accurate clinical evaluation and outcome
measurement. Kannada, being a widely spoken regional language, currently lacks
a standardized version of the SPADI. This study will address this gap by
providing a linguistically and contextually relevant instrument, thereby
enhancing the precision of patient-reported outcomes and supporting
evidence-based management of shoulder conditions among Kannada-speaking
populations |