| CTRI Number |
CTRI/2024/05/066692 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Erector Spinae Plane Block in Prolapsed Intervertebral Disc induced Low Back Pain |
|
Scientific Title of Study
|
Effectiveness of Erector Spinae Plane Block in Chronic Low Back Pain due to Prolapsed Intervertebral Disc: An Exploratory Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varun Thomas Paul P |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of PMR
AIIMS Rishikesh
Pashulok S O
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9447470662 |
| Fax |
|
| Email |
bonjour.varun@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raj Kumar Yadav |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of PMR
AIIMS Rishikesh
Pashulok S O
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8800264547 |
| Fax |
|
| Email |
raj.pmr@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raj Kumar Yadav |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of PMR
AIIMS Rishikesh
Pashulok S O
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8800264547 |
| Fax |
|
| Email |
raj.pmr@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physical Medicine and Rehabilitation, AIIMS Rishikesh
Pashulok S O
Rishikesh
Uttarakhand 249203
India |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Varun Thomas Paul P |
All India Institute of Medical Sciences Rishikesh |
Dept of PMR AIIMS Rishikesh Virbhadra road
Dehradun
UTTARANCHAL |
9447470662
bonjour.varun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block using 0.5% Bupivacaine |
Ultrasound guided Erector Spinae Plane Block with 10ml 0.5% Bupivacaine on each side of paravertebral level as add on to T.Aceclofenac 100mg BD and Physiotherapy for 10 days. |
| Comparator Agent |
The intervention is done as add on therapy in intervention group. |
10 days T. Aceclofenac 100mg BD and Physiotherapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with chronic low back pain and low back pain more than radicular pain due to PIVD resistant to conservative management with Visual Analogue Scale more than five
2.Duration of more than three months.
|
|
| ExclusionCriteria |
| Details |
1.Known case of allergy to local anaesthetics and opioids.
2.Pregnancy and breastfeeding.
3.Coagulation or bleeding disorders and intake of anticoagulants .
4.Pre-existing infection at injection site. 5.Patient refusal.
6.Uncontrolled seizures.
7.Hypertensive emergency.
8.Critical lumbar canal stenosis.
9.Cognitive dysfunction. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
Day 10 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Low Back Pain Questionnaire |
Day 10 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Although Ultrasound Guided procedures like caudal epidural injections and nerve sheath blocks have been tried and proven to be effective in radicular pain due to PIVD no specific intervention has been found to be effective in the treatment of Chronic Low Back Pain due to PIVD. Problem statement: Chronic low back pain (66%) is a common cause of disability in India. The treatment options available for chronic low back pain in PIVD were either less effective or invasive with less effect. Statement of purpose: Role of Erector Spinae Plane block as a less invasive and effective option in relieving chronic low back pain due to PIVD. Hypotheses: Erector Spinae Plane Block has no significant effect in treatment of chronic low back due to PIVD. Alternate hypothesis: Erector Spinae Plane block has significant effect. |