| 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
|
|
|
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
|
|
|
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 GENERATOR™). 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. . |