| CTRI Number |
CTRI/2024/02/063360 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Functional outcomes following different doses of USG-guided steroid
injection in patients with frozen shoulder: A prospective study |
|
Scientific Title of Study
|
Functional outcomes following different doses of USG guided intra-articular steroid
injection in patients with idiopathic frozen shoulder: A prospective 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 |
Dr RONAK MOHANTY |
| Designation |
Junior Resident, Department of Orthopaedics |
| Affiliation |
Kasturba Hospital, MAHE, Manipal |
| Address |
Department of Orthopaedics, Kasturba hospital, Manipal Academy of Higher Education (MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7008553254 |
| Fax |
|
| Email |
ronak.kmcmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrath raj B K |
| Designation |
Associate professor |
| Affiliation |
Kasturba Hospital, MAHE, Manipal |
| Address |
Department of Orthopaedics, Kasturba hospital, Manipal Academy of Higher Education (MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7259695464 |
| Fax |
|
| Email |
amrath.rajbk@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Pandey |
| Designation |
Professor and Unit head |
| Affiliation |
Kasturba Hospital, MAHE, Manipal |
| Address |
Department of Orthopaedics, Kasturba hospital, Manipal Academy of Higher Education (MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8971564313 |
| Fax |
|
| Email |
vivek.pandey@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba hospital, Manipal Academy of Higher Education (MAHE), Manipal, District- Udupi, Pin- 576104, Karnataka |
|
|
Primary Sponsor
|
| Name |
DR RONAK MOHANTY |
| Address |
DEPARTMENT OF ORTHOPAEDICS, KASTURBA HOSPITAL, MAHEE, MANIPAL, UDUPI, 576104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 RONAK MOHANTY |
Kasturba Hospital |
Room number 1, Department of Orthopaedics
Udupi
KARNATAKA |
7008553254
ronak.kmcmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
This is an observational study |
| Intervention |
NIL |
This is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients clinico-radiologically diagnosed as idiopathic frozen shoulder (Non
traumatic shoulder stiffness for more than six weeks).
|
|
| ExclusionCriteria |
| Details |
Evidence of rotator cuff tear on USG, detectable shoulder pathology in shoulder radiograph, secondary shoulder stiffness. History of ipsilateral shoulder trauma for e.g. fracture or dislocation,
patients unfit for injection for e.g. local skin infection and uncontrolled diabetes,
first time diagnosed diabetic of HbA1c of more than 7.5% |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical outcomes based on NRS and SPADI scores at different points of time after the intra-articular shoulder injection. |
Clinical outcomes based on NRS and SPADI scores at different points of time after the intra-articular shoulder injection.
Before shoulder injection, 48 hours post injection, 10 days post injection, 1 month post injection, 3 months post injection, 6 months post injection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Longevity of the effect post intra-articular shoulder injection through SPADI and NRS scores |
48 hours, 10 days, 1 month, 3 months and months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="105" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After obtaining clearances from IEC & CTRI, all
patients who satisfy the inclusion criteria for intra articular steroid injection for primary frozen shoulder(in
freezing stage) will be taken into study. Two established standards of care are practiced in our tertiary
health centre. One orthopaedic surgeon practices 80mg USG guided triamcinolone as his standard of care
and second orthopaedic surgeon practices 40 mg as his standard of care. Prior to the injection, NRS and
SPADI scores will be taken and the patients will followed in an interval of 48 hrs, 10 days, 1 month, 3
months and 6 months. At the end, the collected data will be evaluated for longevity as well as symptom
relief. Confidentiality of each patient will be maintained. |