The objective of this study is to compare the analgesic efficacy of intra-articular facet joint block versus transforaminal epidural injection in patients with lumbar radiculopathy.
Design
A non blinded randomized controlled trial; single-center study with two intervention groups carried out from June 2023 to November 2023
Settings and conduct
The study was conducted in Anesthesia department of Combined Military Hospital Rawalpindi
Participants/Inclusion and exclusion criteria
Inclusion criteria included all male and female patients between ages 30-60 years presenting in the pain clinic after confirmation of lumbar radiculopathy diagnosed by standard MRI imaging studies.
Exclusion criteria included patients with debilitating cardiac or respiratory disease, tumors of the spine with or without metastatic disease, patients with known allergy to lignocaine, bupivacaine or steroids, patients with a regional block done for pain in the last one year.
Intervention groups
The patients were divided into the facet-joint group (Group F) and the epidural group (Group E)
Main outcome variables
Main variables were pain relief after each block and assessed on visual analog score , numerical rating scale and Oswestry disability index.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230829059295N2
Registration date:2023-11-20, 1402/08/29
Registration timing:registered_while_recruiting
Last update:2023-11-20, 1402/08/29
Update count:0
Registration date
2023-11-20, 1402/08/29
Registrant information
Name
Haroon Tariq
Name of organization / entity
Combined military hospital Rawalpindi
Country
Pakistan
Phone
+92 323 7399976
Email address
haroontariq299@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-01, 1402/03/11
Expected recruitment end date
2023-11-30, 1402/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of transforaminal epidural versus intra-articular facet joint injection for treatment of lumbar radiculopathy
Public title
Transforaminal epidural versus intra-articular facet joint injection for treatment of lumbar radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All male and female patients between ages 30-60 years
Confirmed case of lumbar radiculopathy diagnosed by standard MRI imaging studies
Exclusion criteria:
Patients with debilitating cardiac or respiratory disease
Tumors of the spine with or without metastatic disease
Patients with known allergy to lignocaine, bupivacaine or steroids
Patients with a regional block done for pain in the last one year
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by non probability consecutive sampling via lottery method. Patients were divided in to facet joint group (Group F) and epidural group (Group E). Allocation concealment was not done.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of combined military hospital
Street address
Tamizudin road , lalkurti rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
CMH/RWP/412
Health conditions studied
1
Description of health condition studied
Lower backache and hip pain
ICD-10 code
M54.16
ICD-10 code description
Radiculopathy, lumbar region
Primary outcomes
1
Description
Patient satisfaction regarding pain relief after interventional procedure in lumbar radiculopathy
Timepoint
4 weeks and then 3 months post intervention
Method of measurement
Numerical rating scale (NRS) , Visual analog scale (VAS) , Oswestry disability index (ODI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Facet-joint group ( Group F), The procedure was carried out under fluoroscopic guidance with the patient in the prone position under strict aseptic measures. The site of needle insertion was anesthetized using 1% lignocaine on the skin and subcutaneous tissue. Spinal needle (22 G) was inserted, and sequential fluoroscopic views taken. Once appropriate position was reached, 2.5 ml contrast was injected through minibore tubing attached to the needle to confirm correct placement and rule out intravascular placement. One confirmed, 2 ml of 1% preservative-free lignocaine (20mg) with 60 mg of methylprednisolone was injected at the facet-joint site.
Category
Treatment - Other
2
Description
Intervention group: Epidural group ( Group E) patients were placed in the prone position with the targeted site away from the interventionist. An Anteroposterior scout was done at vertebral level T12-S1 to confirm position and level before the procedure. Under fluoroscopic guidance, 2 ml of 1% preservative-free lignocaine (20mg) with 60 mg of methylprednisolone was injected once the needle was in the correct placement after confirmation with 2.5 ml of iodinated contrast.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital
Full name of responsible person
Dr Haroon Tariq
Street address
Tamizudin road, Lalkurti Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273426
Email
haroontariq299@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined military hospital
Full name of responsible person
Dr Rashid Iqbal
Street address
Tamizudin road, lalkurti rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273423
Email
haroontariq299@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined military hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital
Full name of responsible person
Haroon Tariq
Position
Post graduate resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House No 318, Street 5, Sector B1, DHA Phase 1, Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 323 7399976
Email
haroontariq299@gmal.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined military hospital Rawalpindi
Full name of responsible person
Haroon Tariq
Position
Resident anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House 318 ,Street 5, sector B1 , DHA phase one Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 323 7399976
Fax
Email
haroontariq299@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined military hospital Rawalpindi
Full name of responsible person
Haroon Tariq
Position
Resident anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House 318 ,Street 5, sector B1 , DHA phase one Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 323 7399976
Fax
Email
haroontariq299@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data could be provided
When the data will become available and for how long
Data will be available for 2 years starting from December 2023 till December 2025
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Interventional studies being done on the same topic
From where data/document is obtainable
haroontariq299@gmail.com
What processes are involved for a request to access data/document
Please contact the email provided above to ask for the detailed data.