| CTRI Number |
CTRI/2022/11/047558 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the efficacy of radiofrequency ablation in the treatment of chronic low back pain |
|
Scientific Title of Study
|
The effectiveness of radiofrequency denervation of medial branch nerve in the treatment of facet mediated low back pain in adults. A prospective interventional study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ragul D |
| Designation |
Junior resident |
| Affiliation |
jss hospital |
| Address |
Junior resident,
Department of anaesthesiology,
Mahathma Gandhi road,
Fort Mohalla,
Ramachandra Agrahara.
Mysore KARNATAKA 570004 India |
| Phone |
9566822442 |
| Fax |
|
| Email |
raguldharmalingam@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Srinivas H T |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
jss hospital |
| Address |
Department of anaesthesiology,
Mahathma Gandhi road,
Fort Mohalla,
Ramachandra Agrahara.
Mysore KARNATAKA 570004 India |
| Phone |
9986079823 |
| Fax |
|
| Email |
drsrinivashtjss@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Srinivas H T |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
jss hospital |
| Address |
Department of anaesthesiology,
Mahathma Gandhi road,
Fort Mohalla,
Ramachandra Agrahara.
Udupi KARNATAKA 570004 India |
| Phone |
09986079823 |
| Fax |
|
| Email |
drsrinivashtjss@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Medical college and Hospital, Mysuru |
|
|
Primary Sponsor
|
| Name |
Ragul D |
| Address |
Junior resident,
Department of anesthesiology,
JSS Hopsital |
| 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 |
| Ragul D |
JSS Hospital |
PAIN OT,
3RD FLOOR OT COMPLEX. Mysore KARNATAKA |
9566822442
raguldharmalingam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
RADIOFREQUENCY ABLATION |
The duration of therapy is 10mins. The frequency is once. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 LFJ related low back pain >3months
2 Ability to understand study protocol and able to provide voluntary written consent
3 Benefit in pain reduction atleast 50% after intraarticular diagnostic block
4 MRI proven LFJ osteoarthritis |
|
| ExclusionCriteria |
| Details |
1 A lack of positive response after diagnostic block
2 History of osteoporosis, malignancy and trauma.
3 Allergic reaction to local anaesthetics.
4 Pregnancy or lactating
5 Lumbar spinal stenosis, vertebral fractures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain relief |
at Baseline,1 month and at 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life |
at baseline, 1 month and 6 months |
|
|
Target Sample Size
|
Total Sample Size="17" Sample Size from India="17"
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)
|
30/11/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A
thorough pre anaesthetic evaluation will be done 24 hours prior to the
procedure. All patients will be assigned to LFJ intraarticular PRP injection or
RFA of medial branch nerve. The evaluation of the enrolled patients will be
done by experienced Orthopedician and the diagnosis will be based on physical
examination, radio imaging (MRI) and diagnostic block of L3/L4-L5/S1 LFJ with 0.5%
Bupivacaine. Standard monitoring with electrocardiography
(ECG), automated NIBP (noninvasive blood pressure), and pulse oximetry (SpO2) will be done for intraoperative monitoring. Randomization of the participants into two groups id
done by using sealed shuffled opaque envelope technique. Participants will be divided into two groups:- GROUP 1:-Those who are receiving intraarticular PRP
injections GROUP 2:- Those who are receiving RFA of medial branch
nerve This will be a double blinded
study. In both groups, all procedures will be performed by the same experienced
pain physician. The only unblinded personnel in this study is the primary pain
physician. Patients will be unblinded after the 6 months follow up or if
requested before that time. Intraarticular Diagnostic blocks: Patients in prone position, under
fluoroscopy and under strict aseptic conditions, a 22G needle is inserted until
it is contacted at the edge of the LFJ. Adequate needle positioning is
confirmed by injecting 0.3 to 0.5ml of contrast. Once position is confirmed, 1ml
of 0.5% bupivacaine is injected into LFJ. Radiofrequency Denervation:
All RFA procedures are
performed under fluoroscopic guidance. Patients in prone position, under
aseptic conditions, 20G curved 100mm RF needles with active tips are placed at
the site of the dorsal ramus medial branch of the relevant L3/L4-L5/S1 LFJ’s.
Correct placement is confirmed using electrostimulation at 50 HZ for sensory
and 2HZ for motor functions. Then 0.5% bupivacaine is injected through cannula
to decrease procedure related pain. The RF probe is then reinserted into the
cannula and lesioning at a temperature of 80℃ for 90 seconds using RF
generator. Then, inj.dexamethasone 4mg is injected to prevent post operative
neuritis. |