| CTRI Number |
CTRI/2026/03/106082 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound-Guided Nerve Block for participants with Knee Arthritis: Comparing Corticosteroid and Phenol for Pain Relief |
|
Scientific Title of Study
|
Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Corticosteroid v/s Phenol Neurolysis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shiv Lal Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9560678577 |
| Fax |
|
| Email |
slyaiims@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Lal Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9560678577 |
| Fax |
|
| Email |
slyaiims@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Salwan |
| Designation |
Junior Resident Academic |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9781453349 |
| Fax |
|
| Email |
shubhamsalwan2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shiv Lal Yadav |
| Address |
Department of Physical Medicine and Rehabilitation, AIIMS, New Delhi, India, Pin code: 110029 |
| 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 |
| Dr Shiv Lal Yadav |
AIIMS New Delhi |
Room no. 3, Department of Physical Medicine and Rehabilitation, AIIMS, New Delhi
New Delhi
DELHI |
9560678577
slyaiims@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS New Delhi |
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 |
| Comparator Agent |
Corticosteroid + Local Anesthetic |
Triamcinolone acetonide 10 mg (1 ml) mixed with 2 % Lignocaine (0.5 ml) perineural on 3 sites; superomedial, superolateral, inferomedial genicular nerves (Total: 4.5ml)
Total duration: 2 months |
| Intervention |
Phenol Neurolysis |
Phenol 6%, 1.5 ml perineural on 3 sites; superomedial, superolateral, and inferomedial Genicular Nerves (total: 4.5 ml)
Total duration- 2 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients having OA knee (as diagnosed by American College of Rheumatology 1986 clinical and radiographical criteria for OA knee) with KL grade 3 or 4 radiographic changes
Pain Knee (NRS more than 5) during activities of daily living
Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Patient refusal
Uncontrolled Diabetes mellitus or immunosuppression
Local site infection or systemic infection
Allergy to Local Aesthetics
Coagulopathy
Cognitive or behavioral abnormalities
Inflammatory arthritis (Rheumatoid arthritis, Gout)
Radicular pain from spine or hip joint |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess and compare the reduction in knee pain during activities of daily living using NPRS between two treatment groups |
day 0, day 14, day 30, day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate and compare functional improvement using KOOS score following both treatment modalities
Assess and compare patient satisfaction with each treatment approach using patient satisfaction score
Evaluate and compare amount of rescue medications required post treatment in both groups |
day0, day 14, day 30, day 60 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/03/2026 |
| 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
|
This clinical study is a Double Blinded Randomized, active controlled, parallel group trial designed to evaluate and compare the efficacy of 6 percent phenol for ultrasound guided genicular nerves neurolysis v/s combination of local anesthetic with corticosteroid for treatment of patients with chronic knee pain due to osteoarthritis. This study will be conducted in department of Physical Medicine and Rehabilitation at AIIMS, New Delhi A total of 30 participants having osteoarthritis knee with KL grade 3 or 4 radiographic changes and having Knee pain with NPRS more than 5 during activities of daily living will be enrolled in the study and randomized equally into two groups. The intervention group will receive 6 percent phenol and active control group will receive combination of local anesthetic and corticosteroid perineural around 3 genicular nerves namely superomedial, inferomedial and superolateral genicular nerves under ultrasound guidance. All patients will be given standard medical and rehabilitation program comprising of lifestyle modification, home based exercise protocol, knee orthosis as required. Patient will be followed up at 2 weeks, 1 month, 2 months after injection. Medical treatment will be continued to all patients in both groups for entire period of study. If patient in either group developed pain with NPRS more than 5 during study period, tablet paracetamol 500 mg PO SOS to maximum of 500 mg qid can be given as rescue medication. Primary outcome of the study include pain in knee during activities of daily living using NPRS. Secondary outcomes include KOOS score, patient satisfaction score, amount of rescue medications taken
|