| CTRI Number |
CTRI/2017/05/008683 [Registered on: 26/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/05/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study to evaluate the sensitivity of diagnostic single and dual median branch block for diagnosis of facet joint syndrome for radiofrequency neurotomy of medial branch. |
|
Scientific Title of Study
|
Comparison of positive predictive value of diagnostic single vs dual median branch block for Radio-Frequency
neurotomy in lumbar facet joint syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Baibhav Bhandari |
| Designation |
Fellow |
| Affiliation |
ESI Institute of Pain Management |
| Address |
301/3, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
8380070753 |
| Fax |
|
| Email |
dr.baibhav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrata Goswami |
| Designation |
Course Director |
| Affiliation |
ESI Institute of Pain Management |
| Address |
301/3, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
09830430430 |
| Fax |
03323507318 |
| Email |
drsgoswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subrata Goswami |
| Designation |
Course Director |
| Affiliation |
ESI Institute of Pain Management |
| Address |
301/3, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
09830430430 |
| Fax |
03323507318 |
| Email |
drsgoswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI Institute of Pain Management
301/3, Acharya Prafulla Chandra Rd,
Sealdah, Kolkata, West Bengal 700009 |
|
|
Primary Sponsor
|
| Name |
ESI Institute of Pain Management |
| Address |
301/3, Acharya Prafulla Chandra Rd,
Sealdah, Kolkata,
West Bengal 700009
|
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Baibhav Bhandari |
ESI Institute of Pain Management |
301/3, Acharya Prafulla Chandra Rd,
Sealdah, Kolkata,
West Bengal 700009
Kolkata
WEST BENGAL |
8380070753
dr.baibhav@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 |
Lumbar Facet Joint Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Median Branch Block and Median Branch Radio-frequency neurotomy |
Lumbar Median Branch block using 1% lignocaine.
Lumbar median branch radio-frequency neurotomy using conventional radio-frequency at 80 degree celsius for 120 seconds |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Chronic low back pain with or without proximal
non-radicular extremity pain of greater than 3-
month duration.
2.Pain unresponsive to conservative treatment
including medical management, physical therapy,
and previous interventions. |
|
| ExclusionCriteria |
| Details |
1.Pain for less than 3 months
2.Neurological deficits
3.Pregnancy and lactating mother
4.Prior low back surgery
5.Concurrent cervical or thoracic pain or pain
in these regions lasting longer than 2 weeks
during the previous 6 months
6.Primary or metastatic spine tumour or spinal
cord injury.
7.Allergy to medications used in procedure,
blood coagulation disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical rating score (NRS):0-10
Roland Morris Disability Questionnaire (RDQ) :0-24 |
NRS before & after every median branch block and 1 month after neurotomy
RDQ before first median branch block and one moth after neurotomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Roland Morris Disability Questionnaire (RDQ) :0-24 |
RDQ after first median branch block and after second median branch block and before radiofrequency neurotomy |
|
|
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)
|
01/03/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will determine the correlation between Median branch block responses and radiofrequency Neurotomy outcomes, specifically whether patients with concordant analgesic responses to dual controlled MBB have superior radiofrequency Neurotomy outcomes as compared to those with concordant single MBB. 30 patients with facet syndrome will be randomly selected and divided into two groups, namely Group I and Group II. Patients in Group I will be given diagnostic median branch block using 1%, 0.2-0.4 ml lidocaine. Patients in Group II will be given diagnostic median branch block using 1%, 0.2-0.4 ml lidocaine. Patients having atleast 80% pain relief for more than 2 hours will be subjected to second block using 0.25%, 0.2-0.3 ml bupivacaine after an interval of 2-3 weeks after first block. RF Neurotomy will be performed in all the patients having positive response two to three days following MBB in both the groups. Patients in both the groups will be assessed using Numerical Rating Score (NRS) on a scale of 0-10 and Roland Morris Disability Questionnaire (RDQ) on a scale of 0-24 before every MBB and 1 month after the RF Neurotomy. All the data collected will be analysed using appropriate statistical test |