| CTRI Number |
CTRI/2024/08/071790 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Intra-articular steroid injection for knee osteoarthritis in non diabetics and controlled diabetics. |
|
Scientific Title of Study
|
Assessment of the functional outcome of intra-articular steroid injection for knee osteoarthritis in non diabetics and controlled diabetics - An observational 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 Sristi Kumari |
| Designation |
Post graduate trainee |
| Affiliation |
All India Institute of Medical Sciences, Guwahati |
| Address |
Room no. 0016, Pain Clinic, Department of Anesthesiology, Critical care & Pain Medicine, All India Institute of Medical Sciences, Guwahati, Changsari, Assam 781101
Kamrup
ASSAM
781101
India |
| Phone |
9101787548 |
| Fax |
|
| Email |
sristi611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankur Khandelwal |
| Designation |
Associate professor, All India Institute of Medical Sciences, Guwahati |
| Affiliation |
All India Institute of Medical Sciences, Guwahati |
| Address |
Room no. 0016, Pain Clinic, Department of Anesthesiology, Critical care & Pain Medicine, All India Institute of Medical Sciences, Guwahati, Changsari, Assam 781101
Kamrup
ASSAM
781009
India |
| Phone |
7042929671 |
| Fax |
|
| Email |
ankurchintus@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sristi Kumari |
| Designation |
Post graduate trainee |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Guwahati |
| Address |
0016 , Pain Clinic , Department of Anesthesiology , Critical Care and Pain Medicine , All India Institute of Medical Sciences
Kamrup
ASSAM
781101
India |
| Phone |
9101787548 |
| Fax |
|
| Email |
sristi611@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES , GUWAHATI, SILBHARAL , CHANGSARI -781101 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences (AIIMS), Guwahati |
| Address |
All India Institute of Medical Sciences, Changsari,Guwahati, Assam 781101 |
| 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 SRISTI KUMARI |
All India Institue of Medical Sciences , GUWAHATI |
Department of Anaesthesiology, Critical Care and Pain Medicine , Pain Clinic ,0016
Kamrup
ASSAM |
9101787548
sristi611@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals (non-diabetics and controlled diabetics) 45 years of age or older with unilateral or bilateral symptomatic knee pain (NRS ≥4/10) on most days for the past more than 1 month and radiologically (X-ray) confirmed knee OA with Kellgren-Lawrence (KL) radiographic severity grade 2–3 |
|
| ExclusionCriteria |
| Details |
Refusal to consent.
Patients (with or without diabetes) having HbA1c ≥ 7% at baseline
IASI in the past 3 months
History of any systemic inflammatory arthritis
History of trauma, surgery or infection in the affected knee joint
Overlying skin and soft tissue infection
Uncontrolled bleeding diathesis
Known case of cancer
Clinically significant cognitive impairment
Known allergy to triamcinolone acetonide or lignocaine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the responsiveness of intra articular steroid injections in knee osteoarthritic patients. |
baseline and at 2 weeks and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observe CRP levels in each group |
At 2 weeks and 4 weeks |
| Quantify dose of rescue analgesic |
At 2 weeks and 4 weeks |
| Observe local or systemic complications |
At 2 weeks and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2024 |
| Date of Study Completion (India) |
23/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
To observe the functional outcome following intra-articular steroid injection (IASI) at 2 weeks and 4 weeks in knee osteoarthritis in non-diabetics and controlled diabetics as evaluated by The Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Numeric Rate Scale (NRS).We hypothesized that functional outcome after IASI in knee osteoarthritic patients would be better in non- diabetics individuals as compared to diabetic individuals with less requirement of rescue analgesics. |