| CTRI Number |
CTRI/2024/09/073587 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Improvement in pain tolerance and functional improvement in patients with chronic low back pain using 2 type of surgical treatment |
|
Scientific Title of Study
|
Comparison of Functional Improvement in patients of chronic low back pain with facet joint syndrome undergoing Cooled radiofrequency ablation vs Conventional Thermal Radiofrequency Ablation |
| 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 Shivani Rastogi |
| Designation |
Professor(Junior Grade),Department of Anaesthesiology and Critical Care Medicine |
| Affiliation |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW. |
| Address |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES,VIBHUTI KHAND,GOMTI NAGAR,LUCKNOW,PIN CODE 226010.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007201 |
| Fax |
|
| Email |
neuromanu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyotsana chauhan |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW. |
| Address |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES,VIBHUTI KHAND,GOMTI NAGAR,LUCKNOW, PIN CODE 226010.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8081373193 |
| Fax |
|
| Email |
jyotsanaschauhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyotsana chauhan |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW. |
| Address |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES,VIBHUTI KHAND,GOMTI NAGAR,LUCKNOW,PIN CODE 226010.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8081373193 |
| Fax |
|
| Email |
jyotsanaschauhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.R.M.L INSTITUTE OF MEDICAL SCIENCES,VIBHUTI KHAND,GOMTI NAGAR,LUCKNOW,PIN CODE 226010. |
|
|
Primary Sponsor
|
| Name |
DrJyotsana Chauhan |
| Address |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW, PIN CODE 226010. |
| 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 |
| DrJyotsana |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, LUCKNOW |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW, PIN CODE 226010.
PAIN OPD CLINIC ROOM NO:35
PAC CLINIC ROOM NO:11
Lucknow
UTTAR PRADESH |
8081373193
jyotsanaschauhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.Ritu Karoli, CO MEMBER SECRETARY, INSTITUTIONAL ETHICS COMMITTEE, DR RMLIMS LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M469||Unspecified inflammatory spondylopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Thermal radiofrequency ablation |
The RFA lesion is then applied at a temperature of 60- 90 °C for 60-90 s. Traditional RFA for lumbar medial branch nerves is performed at 80 °C for 90 s after each level has been adequately anesthetized.
It has been shown that 45 °C is the threshold for damaging neural tissue . RFA produces heat by current flow and not through heat transfer from the tip, which creates a well-demarcated lesion related to the gauge of the needle and length of the active tip. Secondly, there is formation of an electrical field in the surrounding tissue
|
| Intervention |
Cooled Radiofrequency |
Water-cooled radiofrequency (CRFA) is a newer technique and may have some theoretical advantages over traditional radiofrequency (TRFA). This technology. Similar to TRFA, is also based on the heat neurotomy (60°C in CRFA versus 70-80°C in TRFA). Water circulation (at room temperature) through an isolated channel around the electrode tip creates a continuous “cooling†of the needle tip; consequently, the procedure typically results in a larger spherical- shape ablative area, with a diameter twice as long and extending distally from the tip of the electrode. [5] Thus, CRFA may theoretically increase the success of radiofrequency ablation of the target nerves due to coverage of wider ablative area. As very few studies are present in literature comparing the two modalities Cooled RFA and Conventional RFA. In this prospective comparative non inferiority study, we aim to compare the efficacy, functional outcome, pain relief and complications, in patients undergoing Cooled RFA verses Conventional RFA. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria-
a) Patient of chronic low back pain due to lumber facet syndrome diagnosed by controlled diagnostic ‘median branch block’.
b) Age 18-80 of either sex.
c) Refractory to conservative treatment including activity modification, home exercise, physical therapy, medication
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria-
a) Patient who declined consent.
b) Patient having history of drug allergy.
c) Patient with coagulation abnormality or local site infection.
d) Pregnant patient and patient with pacemaker in situ.
e) Disc herniation, stenosis, myelopathy, lumbar facet
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness and safety and functional improvement by Oswestry Disability Index (ODI) of cooled radiofrequency ablation versus conventional radiofrequency ablation (cRFA) for the treatment of chronic low back pain associated with lumbar facet joint dysfunction. |
Data will be collected at baseline, post intervention, I month, 3 months 6 months post.intervention Statistical analysis will be performed to compare outcomes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary: Visual analog scale (VAS) for pain intensity, multifidus muscle thickness measured by ultrasound, PGIC (Global Patient Impression of Change- Patient Satisfaction)
|
Data will be collected at baseline, post intervention, I month, 3 months 6 months post.intervention Statistical analysis will be performed to compare outcomes
|
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/10/2024 |
| 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
|
Lumbar facet dysfunction is a common cause of chronic low back pain, affecting millions of individuals worldwide. Facet joints are well known source of axial lower back pain, and the prevalence of facet joint pain varies from 20% to 44%. The clinical diagnosis of facet joint mediated pain is challenging due to inadequate sensitivity and specificity of clinical and radiological test. Therefore, medial branch blocks are used for diagnostic purposes in refractory cases, and may provide prognostic value before proceeding with radiofrequency ablation. The diagnostic blocks and radiofrequency treatments are validated in the facet joint mediated lumbar spinal pain. Majority of the studies in the literature are based on the traditional radiofrequency ablation (TRFA) procedure which was proved to be a safe. Effective, and leading pain therapy used to create sensory dysfunction in appropriate nerves via thermal energy. Water-cooled radiofrequency (CRFA) is a newer technique and may have some theoretical advantages over traditional radiofrequency (TRFA). This technology. Similar to TRFA, is also based on the heat neurotomy (60°C in CRFA versus 70-80°C in TRFA). Water circulation (at room temperature) through an isolated channel around the electrode tip creates a continuous “cooling†of the needle tip; consequently, the procedure typically results in a larger spherical- shape ablative area, with a diameter twice as long and extending distally from the tip of the electrode. Thus, CRFA may theoretically increase the success of radiofrequency ablation of the target nerves due to coverage of wider ablative area. As very few studies are present in literature comparing the two modalities Cooled RFA and Conventional RFA. In this prospective comparative non inferiority study, we aim to compare the efficacy, functional outcome, pain relief and complications, in patients undergoing Cooled RFA verses Conventional RFA. |