| CTRI Number |
CTRI/2018/05/014227 [Registered on: 30/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of injection of steroid vs hypertonic dextrose in knee for pain relief in patients of knee arthritis |
|
Scientific Title of Study
|
A comparitive study of intraarticular injection of steroid vs prolotherapy for pain relief in patients of osteoarthritis knee |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashank Kumar |
| Designation |
JR 2 |
| Affiliation |
KGMU |
| Address |
Department of Anaesthesiology, KGMU, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9161929088 |
| Fax |
|
| Email |
shash672009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarita Singh |
| Designation |
Additional Professor |
| Affiliation |
KGMU |
| Address |
Departmemt of Anaesthesiology, KGMU, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8318120314 |
| Fax |
|
| Email |
saritacsmmu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shashank Kumar |
| Designation |
JR 2 |
| Affiliation |
KGMU |
| Address |
Department of Anaesthesiology, KGMU, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9161929088 |
| Fax |
|
| Email |
shash672009@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shashank Kumar |
| Address |
Room no. 202 F, Gautam Buddha Hostel, KGMU, Lucknow |
| 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 |
| Shashank Kumar |
King Georges Medical University |
Pain Clinic, Department of Anaesthesiology, KGMU
Lucknow
UTTAR PRADESH |
9161929088
shash672009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with osteoarthritis knee grade I, II and III, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
25% Dextrose |
8 ml of 25% dextrose intraarticularly at 0, 1 and 2 months |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Triamcinolone acetonide |
Dose 40mg with 1 ml plain lignocaine at 0, 1 and 2 months intraartcularly in knee joint |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Knee osteoarthritis grade I, II and III Patients with VAS > 5 Platelet count < 1.5 lakh |
|
| ExclusionCriteria |
| Details |
Patients giving negative consent. Inflammatory arthritis. History of recent surgery or intraarticular injection of steroid or hyaluronic acid in last 3 months. Patients on active anticoagulant therapy. Liver or haematological/coagulation disorders. Active local site infection/malignancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS score for pain assessment
Quality of life by Mc gill questionarre, dose of rescue analgesia, repetition of doses of rescue analgesia |
At 0, 1 week, 1, 2, 3, 4, 5, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/02/2018 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This prospective randomised single blinded study is to compare pain relief with intraarticular injection of triamcinolone acetonide (steroid) with prolotherapy (25% dextrose) in knee. The patients will be divided into two groups. Group A will be given steroid and group B will be given 25% dextrose intraarticularly in knee. The primary outcome measured will be Visual Analogue Scale at 0 hours to 6 months at monthly interval. |