Comparison of the effectiveness of Interlaminar midline and translaminar parasagittal steroid epidural injection in patients with lumbar spinal stenosis pain
Comparison of the effectiveness of midline and parasagittal interlaminar steroid epidural injection in patients with lumbar spinal stenosis pain
Design
In this randomized clinical trial study, patients with chronic back pain are divided completely randomly based on the block randomization method into two groups of 30: intervention: parasagittal interlaminar and control: midline interlaminar.
Settings and conduct
Patients with chronic low back pain candidates for epidural steroid injection by parasagittal interlaminar/midline interlaminar method, referring to the pain clinic of Imam Hossein Hospital, with the conditions of entry into the study, will be randomly assigned to one of the intervention/control groups in two groups of 30.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for epidural steroid injection; Age 50 years and older; Evidence of lumbar spinal stenosis based on MRI according to Boden criteria.
Exclusion criteria: Foraminal and lateral recess stenosis without central canal stenosis; History of epidural steroid injection in the last six months; Spinal deformity; Indication for surgery.
Intervention groups
Intervention group: epidural steroid injection by parasagittal interlaminar method
Control group: epidural steroid injection by midline interlaminar method
Main outcome variables
Pain, disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131124015515N11
Registration date:2023-03-06, 1401/12/15
Registration timing:prospective
Last update:2023-03-06, 1401/12/15
Update count:0
Registration date
2023-03-06, 1401/12/15
Registrant information
Name
Masoud Hashemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
dr.hashemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-10, 1401/12/19
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Interlaminar midline and translaminar parasagittal steroid epidural injection in patients with lumbar spinal stenosis pain
Public title
Comparing the effectiveness of midline and parasagittal interlaminar methods of epidural steroid injection in patients with lumbar spinal stenosis pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with consent to participate in the study
Age 50 years and above
Radiculopathy
Confirming the diagnosis of lumbar spinal stenosis based on clinical examinations and radiographic findings
Evidence of lumbar spinal stenosis based on MRI according to Boden criteria
Patients suffering from moderate back pain and disability related to neurogenic lameness caused by central spinal stenosis.
Candidate patients for epidural steroid injection
Focal tenderness above the lumbar joint
Hyperextension pain
No history of neurological defects
Contraindications for back surgery
Failure to respond to traditional treatments (rest, drug therapy, physical therapy)
Exclusion criteria:
Foraminal and lateral recess stenosis without central canal stenosis
History of epidural steroid injection in the last six months
Coagulation disorders
Sensitivity to steroid or local anesthetic solution
Malignancy
Psychiatric problems and patient non-cooperation
Speech problems
Pregnancy
Surgical indication
Local skin infections in the operation area
Deformity of the spine
History of lumbar spine surgery
Cauda equina syndrome
Vertebral fracture, tumor or infection in the spine
Inflammatory spondylopathy
Age
From 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by block method. So, initially, in Excel software, there are 6 blocks of 4 as (AA, BB), (BB, AA), (AB, BA), (BA, AB), (AB) (AB, BA), (BA, BA) are prepared and then these blocks will be arranged from one to six. A is for the intervention group and B is for the control group. Then one of these blocks is randomly selected and based on the sequence The letters A and B in the selected block of eligible people will be assigned to the intervention or control groups. This random process of selecting blocks and assigning people to the intervention and control groups will continue until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, so that the evaluator and the subject are not aware of the status of assigning people to the study groups. For the study subjects, before random allocation, it is explained how the work process is and they may receive one of the two methods randomly, and the method used is not known to the subjects in advance, identifying the type of intervention and control method. It is not possible for the patient and the evaluator to communicate with each other, so the patient will be unaware of which group he is in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tabnak St.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-02-11, 1401/11/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.753
Health conditions studied
1
Description of health condition studied
spinal stenosis with chronic pain
ICD-10 code
M48. 06
ICD-10 code description
Spinal stenosis, lumbar region is a medical classification as listed by WHO under the range
Primary outcomes
1
Description
Visual Analogue Scale (VAS) score (0 = no pain, 1-3 mild pain, 4-7 moderate pain and 8-10 severe pain)
Timepoint
Before, one month and three months after injection
Method of measurement
Ask the patient
2
Description
Disability with the Oswestry Disability Index questionnaire
Timepoint
Before, one month and three months after injection
Method of measurement
Ask the patient
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
One month and three months after injection
Method of measurement
Ask the patient
Intervention groups
1
Description
Intervention group: Epidural injection is performed by parasagittal interlaminar method with a 15 cm long No. 22 spinal needle. The correct operation of the needle under fluoroscopic view and anterior-posterior level is shown in the fluoroscopic view. Epidural steroid injection is performed with a mixture of 2 ml bupivacaine 2%, 6 ml distilled water and triamcinolone at a dose of 40 mg/ml (total volume 8 ml).
Category
Treatment - Other
2
Description
Control group: Epidural injection using the interlaminar midline method, the needle is pushed forward from the interspinous midline space with the same parasagittal method. Other stages are the same as the intervention group.