| CTRI Number |
CTRI/2017/06/008734 [Registered on: 01/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of Intraarticular hylan g-f 20, dextrose, ozone and combination of dextrose & ozone in patients with osteoarthritis knee. |
|
Scientific Title of Study
|
Comparative study of intraarticular hylan g-f 20, intra articular dextrose prolotherapy, intra articular ozone and intra articular ozone with dextrose in knee osteoarthritis for pain relief: a randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subrata Goswami |
| Designation |
Course director, ESI Institute of Pain Management |
| Affiliation |
ESI Institute of Pain Management |
| Address |
Flat no 10, Doctors block, 3A/1 Maharani Swarnamayee Road, Kolkata
Pain management department, ESI Hospital, Sealdah
301/3 APC Road, Kolkata 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9830430430 |
| Fax |
|
| Email |
drsgoswami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrata Goswami |
| Designation |
Course director, ESI Institute of Pain Management |
| Affiliation |
ESI Institute of Pain Management |
| Address |
Flat no 10, Doctors block, 3A/1 Maharani Swarnamayee Road, Kolkata
ESI Hospital, Sealdah
301/3 APC Road, Kolkata 700009
WEST BENGAL
700009
India |
| Phone |
9830430430 |
| Fax |
|
| Email |
drsgoswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subrata Goswami |
| Designation |
Course director, ESI Institute of Pain Management |
| Affiliation |
ESI Institute of Pain Management |
| Address |
Flat no 10, Doctors block, 3A/1 Maharani Swarnamayee Road, Kolkata
ESI Hospital, Sealdah
301/3 APC Road, Kolkata 700009
WEST BENGAL
700009
India |
| Phone |
9830430430 |
| Fax |
|
| Email |
drsgoswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI Institute of Pain Management, ESI Hospital Sealdah, 301/3 APC Road, Kolkata 700009. |
|
|
Primary Sponsor
|
| Name |
ESI Institute of Pain Management |
| Address |
301/3, Acharya Prafulla Chandra Rd,
Sealdah, Kolkata, West Bengal 700009
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Subrata Goswami |
ESI Hospital, Sealdah |
ESI Institute of Pain Management, ESI Hospital Sealdah,
301/3, Acharya Prafulla Chandra Rd,
Sealdah, Kolkata, West Bengal 700009
Kolkata
WEST BENGAL |
9830430430
drsgoswami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ESI Institue of Pain management |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Knee osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of dextrose with ozone |
12.5% 10 ml dextrose with 15 mcg/ml 10 ml ozone once per week for 5 weeks |
| Intervention |
dextrose |
12.5% 10 ml intra-articular once per week for 5 weeks |
| Comparator Agent |
high molecular weight hylan g-f 20 |
6 ml intra-articular once |
| Intervention |
ozone |
15 mcg/ml 10 ml once per week for 5 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Pain in the knee
Kellgren – Lawrence grade I,II,III on PA knee radiograph, and grade IV not willing to surgery
Age 50 to 75 years.
Any THREE of the following:
a) Less than 30 minutes of morning stiffness.
b) Crepitus on active movement.
c) Bony tenderness.
d) Bony enlargement.
e) No palpable warmth of synovium.
|
|
| ExclusionCriteria |
| Details |
Systemic disease
On anticoagulants
Knee pain/ swelling due to inflammation, infection etc.
Previous intra articular injection.
Use of opioid analgesics.
Intra articular fluid accumulation.
Patients taking opioid analgesics.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain in Numeric Rating Scale Score |
Day 0 and 2 months after the completion of treatment course |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| function by Western Ontario and McMaster University Arthritis Index (WOMAC) score |
day 0 and 2 months after completion of treatment course |
| Joint space in standing Xray of affected knee joint |
day 0 and 2 months after the completion of treatment course |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2017 |
| 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
|
none yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
60
patients with knee osteoarthritis will be randomly selected and will be divided equally into four groups
- Group D will be treated with dextrose, Group H by high molecular
weight hylan G-F 20, Group O by ozone, Group C by combination of dextrose and ozone both. High molecular hylan G-F 20 will be given once where as dextrose and ozone will be given once per week for 5 weeks. Neumeric Rating Scale (NRS) score and Western Ontario McMaster University Arthritis index (WOMAC) score will be assessed before and two
months after the procedure. 2 months after the completion of the course a
standing X-Ray of affected knee will be done again. Finally pre treatment and
post treatment scores and joint space will be compared. Results
will be computed and analysed by appropriate statistical methods. The
objective of the study was to compare the effect of four treatment
protocols on pain and function by comparison of NRS scale and WOMAC assessment scale respectively. |