| CTRI Number |
CTRI/2020/11/029099 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
12/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the lumbar facet joint nerve block with lumbar facet joint radiofrequency denervation in patients with low back pain to assess improvement in pain, patient satisfaction and complications in both |
|
Scientific Title of Study
|
A study to compare the lumbar facet joint nerve block with lumbar facet joint radiofrequency denervation in patients with low back pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Malhotra |
| Designation |
Professor |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care
Pt BD Sharma PGIMS
UHS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9812091051 |
| Fax |
|
| Email |
drnaveenmalhotra@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Disha Gupta |
| Designation |
JR |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care
Pt BD Sharma PGIMS
UHS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896945104 |
| Fax |
|
| Email |
disha3286@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha Gupta |
| Designation |
JR |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care
Pt BD Sharma PGIMS
UHS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896945104 |
| Fax |
|
| Email |
disha3286@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care
PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical care
Pt BD Sharma PGIMS
UHS Rohtak |
| 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 Disha Gupta |
Pt BD Sharma PGIMS Rohtak |
Department of Anaesthesiology and Critical Care
Pt BD Sharma PGIMS
UHS Rohtak
Rohtak
HARYANA |
9896945104
disha3286@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pt BD Sharma PGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lumbar facet joint nerve block |
Under fluoroscopic guidance 1.5ml drug solution comprising of 0.25% bupivacaine plus 10mg of triamcinolone will be administered via 23 G spinal needle at the site of dorsal ramus medial branch of the relevant lumbar facet joints after confirming adequate needle positioning by injecting 0.5 ml of contrast medium. |
| Intervention |
Lumbar facet joint radiofrequency denervation |
Under fluoroscopic guidance radiofrequency denervation of dorsal ramus medial branch supplying the relevant lumbar facet joints will be done using 20 G curved RF needle with 100 mm active tip to create a lesion with a target temperature of 80 degrees for 90 seconds after confirmation of correct placement of RF cannula using electro-stimulation at 50 and 2 Hz for sensory and motor function respectively |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
history, physical examination and pain pattern consistent with lumbar facet joint pain of at least three months duration
magnetic resonance imaging (MRI) findings consistent with lumbar facet joint arthropathy
failure to respond to six weeks of conservative treatment with a combination of anti-inflammatory drugs, oral narcotic for severe pain and physical therapy
positive diagnostic block with local anaesthetic. |
|
| ExclusionCriteria |
| Details |
Patients with known contraindications for facet joint injection, history of adverse reactions to local anaesthetics or steroids, malignancy, infection, pregnancy or lactating females, vertebral fractures, uncontrolled psychiatric disorders, uncontrolled medical illnesses, previous history of facet joint injection and previous spine surgery will not be included in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Score |
1 hour 2 weeks 1 month 2 months 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Satisfaction |
1 hour 2 weeks 1 month 2 months 3 months |
| Roland-moris questionnaire |
1 hour 2 weeks 1 month 2 months 3 months |
| Oswestry disability questionnaire |
1 hour 2 weeks 1 month 2 months 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/11/2020 |
| 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="3"
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
|
Adult patients aged more than 20 years of either sex having history, physical examination, pain pattern and MRI findings consistent with facet joint arthropathy who have failed to respond to 6 weeks of conservative treatment and a positive diagnostic block with local anaesthetic will be taken for the study. |