| CTRI Number |
CTRI/2024/08/072821 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A cross-sectional study for the translation and standardization of the Shoulder Pain and Disability Index (SPADI) questionnaire into Assamese language |
|
Scientific Title of Study
|
Development of the Assamese Version of the Shoulder Pain and Disability Index (SPADI). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyaranjan Sethi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
OPD Building, Department of Physical medicine and rehabilitation AIIMS Guwahati
Room no 1075
Kamrup
ASSAM
781101
India |
| Phone |
8440963963 |
| Fax |
|
| Email |
satyaranjansethi@aiimsguwahati.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyaranjan Sethi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
OPD Building Department of physical medicine and Rehabilitation AIIMS Guwahati
Room no. 1075
Kamrup
ASSAM
781101
India |
| Phone |
8440963963 |
| Fax |
|
| Email |
satyaranjansethi@aiimsguwahati.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ebenezer kyndiah |
| Designation |
Senior Resident Doctor |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
OPD building Department of Physical Medicine and Rehabilitation AIIMS Guwahati
room no.1073
Kamrup
ASSAM
781101
India |
| Phone |
9436588334 |
| Fax |
|
| Email |
ebenezerkyndiah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physical Medicine and Rehabilitation AIIMS Guwahati INDIA PIN 781101
OPD Building Room No 1072
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Guwahati |
| Address |
Department of Physical Medicine and Rehabilitation Guwahati, ASSAM 781101
OPD BUILDING Room no 1072 |
| Type of Sponsor |
Government 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 |
| Dr Ebenezer C Kyndiah |
All India Institute of Medical Sciences Guwahati |
OPD Building
Department of Physical Medicine and Rehabilitation
Room no. 1073,1072,1076,1075
Kamrup
ASSAM |
9436588334
ebenezerkyndiah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Guwahati Ethic committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Adhesive capsulitis
2.Rotator cuff tendinopathy,
3.Bursitis, shoulder impingement syndrome, fracture of the shoulder joint,
4.Individual who can read and understand Assamese language |
|
| ExclusionCriteria |
| Details |
1.Critically ill patients
2.Neurological causes
3.Mentally challenged patient
4.Patients not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assamese version of Shoulder pain and disability index scale |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A valid & reliable version of SPADI in Assamese applicable in assessing pain & disability in patients with musculoskeletal disorder of the shoulder joint |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
01/09/2024 |
| 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
|
Shoulder dysfunction is the most common
cause of musculoskeletal pain next to back pain and 6-37% of the general population .The Shoulder Pain and Disability Index (SPADI) has become one of the standard outcome measurement tools used in assessment of shoulder problems. SPADI takes 5-10 minutes for a patient to
complete and is only reliable and valid region-specific measure for the
shoulder. Besides the Original English version, SPADI has
been translated and cross culturally adapted in different languages worldwide. However there is no Assamese version of the SPADI despite the large proportion of Assamese speaking population in Assam. Therefore in this study we shall attempt to obtain the SPADI in Assamese version following a systematic standardized process and to evaluate its reliability. |