| CTRI Number |
CTRI/2025/10/095684 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound guided steroid and local anaesthetic injections for osteoarthritis knee: comparing infra articular vs. genicular nerve block approaches |
|
Scientific Title of Study
|
Comparison of Ultrasound guided intra articular local anaesthetic and steroid injection with ultrasound guided genicular block with local anaesthetic and steroid injection in chronic pain due to Osteoarthritis of knee joint |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swagatika Biswal |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr RML Hospital, New Delhi |
| Address |
Room no.301, third floor, Department of Anaesthesia, ABVIMS and Dr. RML Hospital,New Delhi,110001
New Delhi
DELHI
110001
India |
| Phone |
7008348622 |
| Fax |
|
| Email |
swagatikabiswal622@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Gupta |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital, New Delhi |
| Address |
Room no.301, third floor, Department of Anaesthesia, ABVIMS and Dr. RML Hospital,New Delhi,110001
New Delhi
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
drakhileshgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Gupta |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital, New Delhi |
| Address |
Room no.301, third floor, Department of Anaesthesia, ABVIMS and Dr. RML Hospital,New Delhi,110001
New Delhi
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
drakhileshgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital,Baba kharak singh marg,Near Gurudwara bangla sahib, Connaught place, New Delhi, 110001 |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
| Address |
Room no.301, third floor, Department of Anaesthesia, ABVIMS and Dr. RML Hospital,New Delhi,110001 |
| Type of Sponsor |
Government medical college |
|
|
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 Swagatika Biswal |
ABVIMS and Dr. RML Hospital,New Delhi |
Room no.301, third floor, Department of Anaesthesia, ABVIMS and Dr. RML Hospital,New Delhi,110001
New Delhi
DELHI |
7008348622
swagatikabiswal622@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ABVIMS and Dr RMLNHospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparison of ultrasound guided intra articular local anaesthetic and steroid injection with ultrasound guided genicular nerve block with local anaesthetic and steroid injection |
patients will be randomly divided into 2 groups- group A and group B. Group A is the intraarticular group and group B is the genicular nerve block group.Patients will be followed up for NRS score immidiately post procedure and after 1 week and 1 month and 3 month |
| Comparator Agent |
comparison of ultrasound guided intra articular local anaesthetic and steroid injection with ultrasound guided genicular nerve block with local anaesthetic and steroid injection in chronic pain due to osteoarthritis of knee join |
patients will be randomly divided into 2 groups- group A and group B. Group A is the intraarticular group and group B is the genicular nerve block group.Patients will be followed up for NRS score immidiately post procedure and after 1 week and 1 month and 3 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients
2.Diagnosed case of Osteoarthritis Knee with Kellegren- Lawrence grade 3 or grade 4 |
|
| ExclusionCriteria |
| Details |
1. Previous history of knee surgery
2.Dislocated knee
3.Any active infection in knee joint
4.Past intraarticular knee injection or any interventional therapy
5.patients on anticoagulants or bleeding diathesis or uncontrolled diabetes
6.Hypersenitivity to steroid or any local anaesthetic
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain using NRS score immediately post procedure, 1 week, 1 month and 3 months after the procedure |
Assessment of pain using NRS score immediately post procedure, 1 week, 1 month and 3 months after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Functionality assessment by WOMAC Score at 1 week, 1 month and 3 months after the procedure
2.Complications(if any) arising out of the procedure |
1 week, 1 month, 3 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
17/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="11" |
|
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
|
This prospective comparative study (ABVIMS & Dr. RML Hospital, 2025–2026) evaluates pain relief in knee osteoarthritis (OA) using two ultrasound-guided techniques with identical drugs: intra-articular injection (IACSI) versus genicular nerve block (GNB).
Fifty-six adults with unilateral OA (Kellgren–Lawrence Grade 3/4) will be randomized (28 per group). • Group A: Suprapatellar injection of 60 mg triamcinolone + 6 ml 1% lignocaine. • Group B: GNB with 20 mg triamcinolone + 2 ml 1% lignocaine at three genicular nerve sites.
Patients and assessors are blinded. Primary outcome: pain score (NRS) at immediate, 1-week, 1-month, and 3-month intervals. Secondary outcomes: function (WOMAC) and complications.
Statistical analysis (SPSS) will compare efficacy using t-test/Mann-Whitney and chi-square/Fisher’s tests (p < 0.05).
The study addresses limited direct evidence comparing these interventions and may guide whether an extra-articular GNB can match or exceed traditional intra-articular injections for sustained pain control in chronic knee osteoarthritis. |