| CTRI Number |
CTRI/2019/03/018069 [Registered on: 13/03/2019] Trial Registered Prospectively |
| Last Modified On: |
11/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Radiofrequency Neuromodulation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Radiofrequency ablation of genicular nerve versus saphenous nerve for chronic knee pain |
|
Scientific Title of Study
|
Pulsed radiofrequency ablation of genicular nerve versus saphenous nerve for relief in chronic knee pain: a prospective randomized study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arghya Mukherjee |
| Designation |
Fellow, ESI Institute of Pain Management |
| Affiliation |
ESI Institute of Pain Management |
| Address |
Pain Management department, ESI Hosp[ital, Sealdah
301/3 APC Road, Kolkata 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9830430936 |
| Fax |
|
| Email |
arghya.mukherjee5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrata Goswami |
| Designation |
Course Director, EIPM |
| Affiliation |
ESI Institute of Pain Management |
| Address |
Pain Management Department, ESI Hospital, Sealdah
301/3 APC Road, Kolkata 700009.
301/3 APC Road, Kolkata 700009.
Kolkata
WEST BENGAL
700009
India |
| Phone |
9830430430 |
| Fax |
|
| Email |
drsgoswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subrata Goswami |
| Designation |
Course Director, EIPM |
| Affiliation |
ESI Institute of Pain Management |
| Address |
Pain Management Department, ESI Hospital, Sealdah
301/3 APC Road, Kolkata 700009.
301/3 APC Road, Kolkata 700009.
Kolkata
WEST BENGAL
700009
India |
| Phone |
9830430430 |
| Fax |
|
| Email |
drsgoswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI Hospital, Sealdah
301/3 APC Road, Kolkata 700009 |
|
|
Primary Sponsor
|
| Name |
ESI Institute of Pain Management |
| Address |
ESI Hospital, Sealdah
301/3 APC Road, Kolkata 700009 |
| 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 Subrata Goswami |
ESI Hospital, Sealdah |
ESI Institute of Pain Management, Pain Management Department, 301/3 APC Road, Kolkata 700009
Kolkata
WEST BENGAL |
09830430430
drsgoswami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ESI Institute of Pain management |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pulsed radiofrequency of knee genicular nerve |
After positive diagnostic block under fluoroscopy guidance pulsed RF ablation of the affected side supero-medial, supero-later and infero-medial quadrant of knee, at 42 degree celsius for 4 minutes for each point. |
| Comparator Agent |
Pulsed Radiofrequency of Saphenous nerve |
After positive diagnostic block under ultrasonography guidance pulsed RF ablation of the affected side saphenous nerve at 42 degree celsius for 8 minutes. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age between 25 and 65 years.
2) Chronic knee pain (more than 3 months duration).
3) Intensity of pain more than 4 according to VAS.
4) Pain predominantly involving medial compartment of knee joint.
|
|
| ExclusionCriteria |
| Details |
1) Neurological deficit in lower limbs.
2) Prior knee replacement surgery any surgery with prosthesis implantation.
3) Diagnosed tumour or cancer involving knee.
4) Primary or metastatic spine tumor or spinal cord injury.
5) Leg pain due to PIVD.
6) Allergy to medications used in procedure.
7) Blood coagulation disorder.
8) Pregnancy.
9) Psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pain in VAS Score
2) Functional improvement in WOMAC score |
Pre procedure and at 2 weeks, 6 weeks, 12 weeks and at 20 weeks post PRF treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of Pain relief |
Pre procedure and at 2 weeks, 6 weeks, 12 weeks and at 20 weeks post PRF treatment. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective
randomized study to compare the efficacy of genicular nerve and saphenous nerve pulsed radiofrequency ablation (PRFA) for the relief of chronic knee pain. After obtaining proper informed consent, and maintaining the
inclusion and exclusion criteria, 30 patients, over one year of study period there will be diagnostic block followed by PRFA procedure
dividing the study population in two separate groups. Assessment of duration
and quality of pain relief will be done followed by calculation by applying a
specific formula mentioned, and will be expressed appropriately. |