| CTRI Number |
CTRI/2024/03/063419 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
"Addition of 5% dextrose around the genicular nerve"- A novice approach to increase the efficacy of regenerative therapy in Osteoarthritis knee. |
|
Scientific Title of Study
|
A single-centric, double-blinded randomized parallel group non-inferiority study to explore the synergistic effectiveness of perineural genicular nerve injection with 5% Dextrose in osteoarthritis knee receiving intra articular Platelet rich Plasma and Hyaluronic Acid. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhamay Nanda |
| Designation |
Fellow resident |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor,
327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
09438167676 |
| Fax |
|
| Email |
subhamayn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Das |
| Designation |
Director |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor
327,9/2DG block, Action area 1D,newtown, Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
09163357246 |
| Fax |
|
| Email |
gdas2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Das |
| Designation |
Director |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor
327,9/2DG block, Action area 1D, newtown, Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
09163357246 |
| Fax |
|
| Email |
gdas2310@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown kolkata West Bengal, pin-700156 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Subhamay Nanda |
Daradia the pain clinic |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block action area 1D, newtown,kolkata
pin-700156
Kolkata
WEST BENGAL |
9438167676
subhamayn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DARADIA 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
|
| Type |
Name |
Details |
| Intervention |
5% Dextrose water |
Single injection of 2 ml 5% Dextrose around each genicular nerve by perineural approach. |
| Comparator Agent |
0.9% Normal saline |
Single injection of 2 ml 0.9% normal saline around each genicular nerve by perineural approach. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) patients willing to take part in the study and aged 50–80 years who presented with chronic knee pain, (i.e., knee pain of moderate or greater intensity on most or all days for ≥ 3 months)
2)Following radiological assessments, radiological tibiofemoral OA (Kellgren-Lawrence grade 2–4 as evaluated by a radiologist
|
|
| ExclusionCriteria |
| Details |
acute knee pain, prior knee surgery, other connective tissue diseases that affected the knee, serious neurological or psychiatric disorders, steroid or hyaluronic acid injection therapy during the previous 3 months, sciatic pain, anticoagulant medication use and platelet count less than 1,50,000 per microliter. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The mean changes from baseline levels of knee pain using VAS |
24hrs, 72hrs, 4, and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional changes in the knee (global perceived effect), patient satisfaction with treatment, changes in analgesics, the incidence of adverse effects, and the proportion of successful responders |
24hrs, 72hrs, 4, and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
We postulate that the application of perineural genicular nerve blocks(GNB) by injecting 5% dextrose water will further augments the treatment effectiveness of PRP+HA offering long-lasting pain and functional improvements of the knee joints. |