Comparison of hyaluronidase Vs. hypertonic saline 5% effects in Percutaneous Caudal Epidural Adhesiolysis With the Racz Technique for patients with Failed Back Surgery Syndrome
Comparison of hyaluronidase Vs. hypertonic saline 5% effects in Percutaneous Caudal Epidural Adhesiolysis With the Racz Technique for patients with Failed Back Surgery Syndrome
Design
Clinical trial with intervention and control groups, 60 patients sample size, Trial phase 2-3
Settings and conduct
Tertiary regional and teaching hospital. Participants including major eligibility criteria, among the patients who were candidates for epidural injection with the Racz Technique referred to the Akhtar Hospital in 2019, 60 were selected by Sequential method, and accidentally divided into two groups of control and intervention according to the random numbers table.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Age 18 and above ; Epidural Adhesion Detection Based on Clinical and MRI Findings ; History of chronic low back pain after surgery for more than six months .
Exclusion criteria: Facet joint arthritis ; Lumbar disc degenerative
Intervention groups
Intervention group: Injection of bupivacaine 0.25% (8 ml), triamcinolone 40 mg (1 ml), normal saline 0.9% (2 ml), hyaluronidase 1500 IU via Racz catheter
Control group: Injection of bupivacaine 0.25% (8 ml), triamcinolone 40 mg (1 ml), normal saline 0.9% (2 ml), hypertonic saline 5% via Racz catheter
Main outcome variables
Pain Level; disability.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131124015515N7
Registration date:2019-07-28, 1398/05/06
Registration timing:prospective
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
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
2019-07-31, 1398/05/09
Expected recruitment end date
2020-02-18, 1398/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hyaluronidase Vs. hypertonic saline 5% effects in Percutaneous Caudal Epidural Adhesiolysis With the Racz Technique for patients with Failed Back Surgery Syndrome
Public title
Comparison of the Effect of Hyaluronidase and Hypertonic Saline 5% on Removal lumbar spinal space adhesion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above
Epidural Adhesion Detection Based on Clinical and MRI Findings
History of spinal surgery
History of chronic low back pain after surgery for more than six months
Radicular or axial back pain
Herniated disk
Patients with satisfaction to participate in the study
Exclusion criteria:
Facet joint arthritis
History of epidural injection or other invasive treatments in the last six months
Severe central lumbar canal stenosis
Stenosis caused by scoliosis
Lumbar disc degenerative
Sacroiliac joint disease
Severe cardiopulmonary disease, uncontrolled diabetes, obesity
History of misuse of any type of narcotic, opioid and alcohol
Pregnancy, breastfeeding
Psychiatric problems and patient's lack of cooperation, speech problems
Surgical indication
Topical skin infections in the area of the surgery
Coagulation disorder
Contraindication for Epidural Lumbar Injection
Patients dissatisfied with participation in the study
Age
From 18 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
Simple randomization based on random numbers table, in this method, we set a set of numbers without a specific pattern and order, and completely randomly in the table, we will read the table numbers from the direction above. For the intervention group, we consider the even numbers and the control group for the odd numbers. Then put on one of the numbers and move upwards, register the number and assign one to an intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and clinical outcomes evaluator are not aware of the code assigned to each of the groups.
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.,Tehran, Tehran, Iran, Islamic Republic Of
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.SBMU.REC.1398.008
Health conditions studied
1
Description of health condition studied
Failed Back Surgery Syndrome
ICD-10 code
M96.1
ICD-10 code description
Postlaminectomy syndrome, not elsewhere classified
Primary outcomes
1
Description
Pain Level
Timepoint
Before treatment, one, three and six months after treatment
Before treatment, one, three and six months after treatment
Method of measurement
Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After placing the Racz catheter under fluorescope and determining the location of the lesion, 10-20 ml of saline solution with 1500 IU of hyaluronidase, 0.25% of bupivacaine and triamcinolone 40 mg are introduced into the epidural space of the caudal through the Racz catheter.
Category
Treatment - Drugs
2
Description
Control group: After placing the Racz catheter under fluorescope and determining the location of the lesion, 10-20 ml of hypertonic saline 5%, 0.25% of bupivacaine and triamcinolone 40 mg are introduced into the epidural space of the caudal through the Racz catheter.