| CTRI Number |
CTRI/2025/08/092943 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two treatments to reduce long-term knee pain in arthritis patients – nerve blockade by ablation vs steroid injection using ultrasound guidance
|
|
Scientific Title of Study
|
Comparative study to assess the analgesic efficacy of Cooled Radio Frequency Ablation of genicular nerve and Intra Articular CorticoSteroids, under ultrasound guidance for chronic knee pain from Osteoarthritis knee. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V Vaishnavi |
| Designation |
Junior resident- Anaesthesia PG |
| Affiliation |
|
| Address |
Department of Anaesthesiology
New modular OT
1st floor, B block, ESIC MEDICAL COLLEGE AND HOSPITAL
KK NAGAR, CHENNAI 600078
Chennai TAMIL NADU 600078 India |
| Phone |
9789993988 |
| Fax |
|
| Email |
vaishu.8492@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
V Vaishnavi |
| Designation |
Junior resident- Anaesthesia PG |
| Affiliation |
|
| Address |
Department of Anaesthesiology
New modular OT
1st floor, B block, ESIC MEDICAL COLLEGE AND HOSPITAL
KK NAGAR, CHENNAI 600078
Chennai TAMIL NADU 600078 India |
| Phone |
9789993988 |
| Fax |
|
| Email |
vaishu.8492@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
V Vaishnavi |
| Designation |
Junior resident- Anaesthesia PG |
| Affiliation |
|
| Address |
Department of Anaesthesiology
New modular OT
1st floor, B block, ESIC MEDICAL COLLEGE AND HOSPITAL
KK NAGAR, CHENNAI 600078
Chennai TAMIL NADU 600078 India |
| Phone |
9789993988 |
| Fax |
|
| Email |
vaishu.8492@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital,Ashok pillar main road,Kk nagar,Chennai 600078 |
|
|
Primary Sponsor
|
| Name |
ESI medical college and hospital |
| Address |
Ashok pillar road, Kk nagar, Chennai 600078 |
| 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 Ilango Ganesan |
ESI Medical College and Hospital |
Department of Anaesthesiology
New modular OT
1st floor, B block, ESIC MEDICAL COLLEGE AND HOSPITAL
KK NAGAR, CHENNAI 600078 Chennai TAMIL NADU |
9884149429
gilang@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
Intra articular steroids |
Intra articular corticosteroids to treat OA knee pain |
| Intervention |
Radio frequency ablation |
Cooled radio frequency ablation of genicular nerves to treat OA knee pain |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with ACOR criteria with radiological evidence but not willing for surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal, bleeding diathesis, previous Intra articular injection in last 3 months, previous knee surgeries, rheumatoid arthritis, ligament injuries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare analgesic efficacy of cooled RFA of genicular nerve and Intra articular cortico steroids under ultrasound guidance for chronic knee pain in OA knee |
Time point of pain assessment pre procedure, immediately after procedure, 24 hrs, 1 week, 2 week and 4 week interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess improvement of knee function |
Assessed using WOMAC score |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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 Yet Recruiting |
| 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
|
Osteoarthritis (OA) is one of the most common degenerative disorders among the elderly population. Around 23.46 million individuals in India had OA in 1990; this increased to 62.35 million in 2019. DALY (Disability Adjusted Life Years) due to OA increased from 0.79 million to 2.12 million. OA was the 20th most common cause of YLDs ( Years Lived in Disability) in India in 2019, accounting for 1.48% of all YLDs; increasing from 23rd most common cause in 1990 . Knee OA was the most common form of OA, followed by hand OA. The prevalence, incidence, and DALYs for OA and knee OA were consistently higher in females than male [1]. The current treatment of OA knee consists of conservative management such as exercise, physical therapy, pharmacological agents such as NSAIDS. Intake of analgesics to alleviate pain will cause renal damage, gastritis, peptic ulcers etc. When the conservative management fails to relieve pain, non surgical procedures like Intra Articular Injection of Cortico Steroids[2], Hyaluronic Acid [3][4], Platelet Rich Plasma [5] is widely used.The definitive treatment for OA knee is total Knee replacement surgery. Intra Articular CorticoSteroids is one of the most commonly used minimally invasive OPD ( Out Patient Department) procedure where a corticosteroid drug is injected into intra articular space to alleviate pain. IACS decreases joint inflammation there by decreasing the pain for a short duration ( wks to months).
The radio frequency ablation is a new treatment methadology for chronic degenerative knee pain. The goal of cooled radio frequency ablation (CRFA) of genicular nerve is to alleviate the knee pain and improve the function and the quality of life of patients with OA knee. It is also a OPD procedure , done without any incision, recovery time is short and the patient can get back soon to their normal day to day activities. Under ultrasound guidance, RF needles will be inserted near the targeted nerves and a gentle electric current ( cooled) is passed through it to ablate the nerve. Cooled RFA is better than conventional RFA, as it targets a wider region and chance of ablating the nerve is high. As per previously published articles, the pain relief after RFA procedure may last for 6 month to 1 years duration. Nerves start to regenerate after 6 months and the procedure will provide control over pain long enough for rehabilitation. Both the procedures are well tolerated in office setting under local anaesthesia or done in operating room under conscious sedation using a low dose sedative such as midazolam for anxious patients. |