| CTRI Number |
CTRI/2021/08/035737 [Registered on: 17/08/2021] Trial Registered Prospectively |
| Last Modified On: |
11/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
What is better for pain relief in patients with chronic knee pain due to osteoarthritis knee? Ultrasound guided local anaesthetic injection or steroid
|
|
Scientific Title of Study
|
To assess the effectiveness of Ultrasound guided genicular nerve block using 0.5% Bupivacaine in comparison with Ultrasound guided intra articular injection of 40mg Depo-Medrol in the management of chronic osteoarthritis knee pain-Double blinded randomized 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 |
Kalaivani P |
| Designation |
Post graduate |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
9003222371 |
| Fax |
|
| Email |
kalai.krenos@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Judy Ann John |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
|
| Fax |
|
| Email |
judy@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kalaivani P |
| Designation |
Post graduate |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
9003222371 |
| Fax |
|
| Email |
kalai.krenos@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College
Vellore
Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College
Vellore
Tamilnadu |
| 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 |
| Kalaivani P |
Department of Physical Medicine and Rehabilitation |
Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore
Vellore
TAMIL NADU |
9003222371
kalai.krenos@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board,Christian Medical College, Vellore |
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 |
Genicular nerve block using 0.5% bupivacaine |
Ultrasound guided genicular nerve block using 0.5% bupivacaine 2ml each to superolateral, superomedial and inferomedial genicular nerves along with standardised exercise programme. Patient will be followed up at different time intervals. i.e., in a week and at 4,12 weeks by telephonic interview |
| Comparator Agent |
Intra articular injection using Depo Medrol and 0.5% Bupivacaine |
Ultrasound guided intra articular injection using 1ml of 40mg Depo Medrol and 3ml of 0.5% bupivacaine along with standardised exercise programme. Patient will be followed up at different time intervals.i.e.,in a week and at 4,12 weeks by telephonic interview |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Chronic osteoarthritis knee with more than 3 months of pain with pain scored by visual analog scale more than or equal to 40mm
Radiological osteoarthritis grade greater than Kellegren Lawrence grade 2
Refractory knee osteoarthritis pain not alleviated with first line of treatment
Well controlled diabetes
No signs of active infection at injection site
|
|
| ExclusionCriteria |
| Details |
Patients who underwent prior knee surgery or surgery scheduled in the next 3 months
Patients with severe knee joint instability
Patients with serious neurological or psychiatric illness
Those received steroid or hyaluronic acid injection therapy in last 3 months
Those who on anticoagulant medication use and those with severe bleeding diathesis
Patients with hypersensitivity to local anaesthetics or steroids |
|
|
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 |
| Mean change in knee pain assessed by Visual Analog Scale |
At 1,4 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in Lequesne Functional Index
Incidence of adverse events
Compliance to home based programme |
At 1, 4 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/08/2021 |
| Date of Study Completion (India) |
23/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
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
|
Osteoarthritis is an active
degenerative process involving cartilage destruction, subchondral remodelling
and formation of osteophytes. The most common symptom in patients with OA knee
is mechanical knee pain. Exercise programme and joint
protection techniques are recommended in all guidelines to manage
osteoarthritis knee. Pain very often results in poor compliance for exercises.
GNB for pain relief can improve compliance to exercise programme.
The objective of this study is to
assess the mean change in knee joint pain as measured by VAS score (0-100mm) on
receiving genicular nerve block with 2ml of 0.5% bupivacaine to
superomedial(SMGN), superolateral(SLGN) and inferomedial genicular
nerves(IMGN), when compared to intra articular injection of 40mg of Depo-Medrol
in those with chronic osteoarthritis knee pain. Patients with more than 3
months of pain will be recruited in this study. Participants will be randomized by block
method. Opaque envelopes will be used to conceal allocation of patients to the
control and interventional group. Intervention group will receive genicular nerve
block with 2 ml of 0.5%bupivacaine to SMGN, SLGN, IMGN along with standardized
exercise programme and control group will receive intra articular injection
with 40mg of Depo-Medrol in knee joint along with standardized exercise
programme. Pre and post procedure VAS and LFI will be documented in 1st
week and then at 4 weeks and 12 weeks by telephonic assessment. |