| CTRI Number |
CTRI/2019/11/022182 [Registered on: 27/11/2019] Trial Registered Prospectively |
| Last Modified On: |
09/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Ozone gas] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare effectiveness of two different intervention - Intraarticular Injection of ozone and steroid into the knee joint in osteoarthritis of knee |
|
Scientific Title of Study
|
Effectiveness of intra-articular Ozone therapy on quality of life and knee function compared with intra articular steroid in patients with primary osteoarthritis of knee : A Randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shanavas Anoth Meethal |
| Designation |
Post graduate student |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
8943714147 |
| Fax |
|
| Email |
shanavasanme@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Bimol |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005291542 |
| Fax |
|
| Email |
bimoldr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Bimol |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005291542 |
| Fax |
|
| Email |
bimoldr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences,Lamphelpat, Imphal- 795004, Manipur, India |
|
|
Primary Sponsor
|
| Name |
Shanavas Anoth Meethal |
| Address |
Post Graduate Trainee
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Lamphelpat, Imphal- 795004, Manipur, India |
| 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 |
| Shanavas Anoth Meethal |
Regional Institute of Medical Sciences |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Lamphelpat, Imphal- 795004, Manipur, India
Imphal West
MANIPUR |
8943714147
shanavasanme@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, RIMS, Imphal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra articular injection of Ozone into the knee |
One dose of intra articular injection of 10 ml Ozone gas into the knee |
| Comparator Agent |
Intra articular injection of steroid into knee |
One dose of Intra articular injection of Methyl Prednisolone 80 mg (2 ml) into the knee |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with symptom duration more than 3 months
Patient with Kellgren-Lawrence Grade 2 or 3
Patients who give willingness to participate and comply with treatment and follow up |
|
| ExclusionCriteria |
| Details |
Recent knee trauma or knee surgery
Any other knee disease or infection
Metabolic disease of bone
Cognitive impairment
Uncontrolled systemic disease
Bleeding disorders
Recent myocardial infarction or stroke
Intra articular steroid injection during past 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of Life in terms of SF-36 score
|
1 Week, 4 Weeks, 12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knee function in terms of WOMAC index |
1 week, 4 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2019 |
| Date of Study Completion (India) |
10/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel group, active controll trial comparing the effectiveness of intra articular injection of Ozone 10ml in quality of life and knee function with intra articular injection of methyl prednisolone 80 mg(2ml) in 54 patients with Primary osteoarthritis of knee that will be conducted in Department of Physical Medicine and Rehabilitation , Regional Institute of Medical sciences, imphal, manipur in India. The primary outcome measures will be Quality of Life in terms of SF-36 score at 12 weeks and Knee function in terms of WOMAC Index at 12 weeks. The secondary outcomes will be Quality of Life in terms of SF-36 score at 1 week, 4 weeks and Knee function in terms of WOMAC Index at 1 week , 4 weeks. |