FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072701 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the quality of recovery in patients of osteoarthritis of knee joint using continuous neuroablative radiofrequency with that of pulsed neuromodulative radiofrequency procedure under Xray guidance 
Scientific Title of Study   Comparison of the efficacy of fluoroscopic guided continuous neuroablative versus pulsed neuromodulative radiofrequency of genicular nerves in patients of 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  Dr Satish Mahur 
Designation  Post Graduate Junior Resident  
Affiliation  Government Medical College and Hospital Sector32 Chandigarh  
Address  Department of Anaesthesia and Intensive Care,Block-D, Level-5, GMCH,Sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  8310124306  
Fax    
Email  csatish060@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dheeraj Kapoor 
Designation  Professor  
Affiliation  Government Medical College and Hospital Sector 32 Chandigarh  
Address  Department of Anaesthesia and Intensive Care,Block-D,Level-5, GMCH,Sector 32,Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121549  
Fax    
Email  Kapoor.dheeraj72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dheeraj Kapoor 
Designation  Professor  
Affiliation  Government Medical College and Hospital Sector 32 Chandigarh  
Address  Department of Anaesthesia and Intensive Care,Block-D,Level-5, GMCH,Sector 32,Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121549  
Fax    
Email  Kapoor.dheeraj72@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, Block D, Level 5, Government Medical College and Hospital,Sector 32B, Chandigarh, India, Pincode-160030 
 
Primary Sponsor  
Name  Government Medical College and Hospital  
Address  Department of Anaesthesia and Intensive Care, Block-D, Level-5 , GMCH,Sector 32B,Chandigarh, india, pincode-160030 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Satish Mahur  Government Medical College and Hospital, Chandigarh   Department of Anaesthesia and Intensive Care, Block-D, Level-5,GMCH,Sector 32B,Chandigarh, India, Pincode -160030
Chandigarh
CHANDIGARH 
8310124306

csatish060@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GMCH, Chandigarh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  continuous neuroablative radiofrequency (CNARF)   The CNARF therapy employs higher frequency alternating current by specially designed needles to induce thermal lesions using dedicated radiofrequency generator machine. The heat energy generates a well defined region of coagulative necrosis that specifically targets the neurons involved in transmitting or modifying pain sensation.The tissue temperature is elevated to a range of 60-80° for a duration of 90 seconds, resulting in the breakdown of the nerves responsible for transmitting pain signals. This procedure carries a risk of damaging motor fibres and causing differentiation. Participation in the study required through a period of 3 months including follow up. 
Comparator Agent  Pulsed neuromodulative radiofrequency (PNMRF)   The PNMRF therapy utilises high voltage (usually 45V) in bursts of 20 milliseconds, followed by silent phases of 480 milliseconds. The long silent phases allow the tissue temperature to spread evenly, preventing it from occurrence of thermal tissue damage. From a molecular perspective, this treatment seems to predominantly regulate signalling pathway in the C fibres while preserving nerve conduction in myelinated fibres. Participation in the study required through a period of 3 months including follow up. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Chronic knee pain of moderate to greater intensity with VAS score more than 3 for more than 3 months
2.Patients with radiological based Kellgren and Lawrence Grade 2, 3 and 4 osteoarthritis knee. 
 
ExclusionCriteria 
Details  1. Patients with acute knee pain
2. Patients with history of prior knee surgery
3. Patient with severe heart, lung, hepatic, renal, psychiatric, neurological, connective tissue disorder, uncontrolled diabetes mellites or hypertension
4. Patients who received intra articular knee injections with steroid or hyaluronic acid within last three months
5. Severe bleeding diathesis or on anticoagulation therapy
6. Patient with temporary or permanent cardiac pacemaker
7. Presence of systemic infection or local infection at the injection site
8. Significant allergic reaction or hypersensitivity to contrast, anaesthetic, or corticosteroids
9. Patient diagnosed with other malignancy
10. Patient on uncontrollable or unstable opioid use  
 
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 the analgesic efficacy of CNARF versus PNMRF using visual analogue scale (VAS) in patients of osteoarthritis knee.  Pain assessment of patient by VAS score at pre-intervention, 1, 2 and 3 month postintervention.  
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of functional improvement achieved by CNARF versus PNMRF using Western Ontario McMaster Universities‘ (WOMAC) index of osteoarthritis.
2. Comparison of participants satisfaction achieved by CNARF versus PNMRF using five point Likert scale. 
1.Functional improvement of the patient assessed by WOMAC score at pre-intervention, 1, 2 and 3 month post-intervention.
2.Patient satisfaction level by Likert five point scale at pre-intervention, 1, 2 and 3 month post-intervention.
 
 
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 4 
Date of First Enrollment (India)   23/08/2024 
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="1"
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   A total of 40 patients will be randomly allocated to either Group-C or Group-P, with 20  patients in each group.Group C (n=20): fluoroscopic guided continuous neuroablative radiofrequency of genicular nerves Group P (n=20): fluoroscopic guided pulsed neuromodulative radiofrequency of genicular nerves.

All patients will be explained about the procedure and positioned in supine position on the fluoroscopy table with the affected leg flexed by 30-40 degrees, using a bolster placed underneath the knee. The procedure will be performed under local anaesthesia at the site of needle insertion and will be given conscious sedation with midazolam 1-2 mg IV and or titrated dose of fentanyl (0.5-1 mcg/kg IV), as and when required. Sterile tray will be prepared constituting sterile gloves, disposable 10 ml syringes, 26 G 3 inch hypodermic needles, connection tubing, and 22 G RF needle. A mixture of ropivacaine and triamcinolone acetonide (7 ml of 0.2% ropivacaine and 80 mg of triamcinolone acetonide) under aseptic precautions will be prepared and will kept on sterile tray. Skin preparation will be done with povidone iodine solution (10%).  
 C-arm fluoroscope will be subsequently positioned to obtain imaging of knee joint in anteroposterior (AP) and lateral view. The procedure is guided using  fluoroscope and neurostimulation integrated in RF machine (COOLIEF RF GENERATORâ„¢). In the AP fluoroscopic view, the superior lateral and superior medial genicular nerve will be located at the confluence of the lateral and medial femoral shaft and the lateral and medial femoral condyle, respectively. The depth of the needle tip at the midpoint of the femur is further confirmed by  lateral fluoroscopic view.  The inferior medial genicular nerve was located at the confluence of the medial tibial shaft and the tibial flare by AP fluoroscopic view and further the needle tip depth at the midpoint of the tibia will be done by lateral fluoroscopic view.  Local infiltration of 1-2 ml of 2% lignocaine hydrochloride will be injected subcutaneously at each mentioned point of insertion of RF needle. For each genicular nerve, a 10 cm long, 22-G RF needle with a 10-mm active tip will be advanced under fluoroscopy with the assistance of anteroposterior and lateral knee imaging. Final position of the needles will be further confirmed by RF electrode by sensory (50 Hz, up to 1.0 V) and motor (2 Hz, 2.0 V) stimulation.   The settings of CNARF ablation of the target nerve will be carried out at 80°C and 20 V for 90 seconds and PNMRF will be carried out at 42°C and 45V with 3 cycles of 120 seconds at each genicular nerve
Following the RF procedure, 3 ml of sterile solution (7 ml of 0.2% ropivacaine and 80 mg of triamcinolone acetonide) prepared before, was administered at each of three RF lesion site before withdrawing the needle. A sterile dressing will be applied. Patients will be instructed to lie in a supine position after the procedure for next 30 minutes in the recovery room and vitals will be monitored.  
Pain assessment of patient by VAS score, Functional improvement of the patient assessed by WOMAC score, Patient satisfaction level by Likert five point scale will be recorded at pre-intervention, 1, 2 and 3 month post-intervention. .
 
Close