| CTRI Number |
CTRI/2025/08/093269 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Finding the Cause of Wrist Pain Using MRI Scans |
|
Scientific Title of Study
|
Role of 3.0 Tesla Magnetic Resonance Imaging MRI in the Evaluation of Wrist pain. |
| 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 Muskan Jagnani |
| Designation |
Post Graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radio-diagnosis, Ground Floor, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9711303930 |
| Fax |
|
| Email |
drmuskanjagnani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivali Kashikar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radio-diagnosis, Ground Floor, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9822471380 |
| Fax |
|
| Email |
shivalikashikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivali Kashikar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radio-diagnosis, Ground Floor, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9822471380 |
| Fax |
|
| Email |
shivalikashikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442107 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Meghe, Wardha, India 442107 |
| 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 |
| Dr Muskan Jagnani |
Acharya Vinoba Bhave Rural Hospital |
Department of Radio-diagnosis, Ground Floor, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA |
9711303930
drmuskanjagnani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional E Add Ethics Committee Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with wrist pain complaints
2.Patients of age group 18 or above irrespective of sex referred to the department of Radio-Diagnosis at AVBRH, Sawangi
3.Patients giving consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with cardiac pacemaker, metallic implants in the body and those with the history of claustrophobia or any contraindication to MRI
2.Patients with severe open wounds, infections, or burns on or around wrist
3.Patients with previous surgical interventions of the wrist
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study is expected to provide valuable insights into the effectiveness of 3.0 Tesla MRI in diagnosing wrist pain, particularly in cases where clinical evaluation and conventional imaging fall short |
Assessment will be done at 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2025 |
| 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="2"
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
|
Wrist pain is a
common clinical complaint with a wide differential diagnosis. Wrist joint is a
complex structure composed of bones, ligaments, tendons and muscles and
compartments of wrist. Injuries to this joint can lead to significant
functional impairment. This study explores the role of MRI in the diagnosis, assessment and
work up of wrist pain. The aim is to evaluate the effectiveness of MRI in
identifying various types of wrist injuries causing wrist pain. This study will be conducted at Department of Radio-diagnosis in AVBRH Hospital, Wardha. A sample size of 30 cases will be assessed. |