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A comparison study of the effects of Triamcinolone and magnesium sulfate in caudal neuroplasty in chronic low back pain.

Protocol summary

Study aim
Comparative study of the effect of triamcinolone and magnesium sulfate in caudal neuroplasty in chronic low back pain
Design
A double blind, randomized clinical trial with control group; community based and pragmatic; with parallel group design; phase3
Settings and conduct
This study is carried out at the Rassoul Akram Therapeutic Complex. Fifty patients with lumbar radiculopathy were randomly divided into two groups. In both groups, drugs are injectable and the injection site of the drug in the patient's body is in same area. Therefore, patients are not aware of the type of the drug. Also, the outcome evaluator is unaware of the random allocation. In the first group, triamcinolone (80 mg), and in the 2nd group, magnesium (50 mg) was injected into the caudal space. In the 2nd day, the same drug with half dose of the first day was injected via a catheter. The evaluation criteria included physical examinations, pain scale, Disability Index, analgesic consumption before, 2 weeks, and 1, 3, and 6 months later; blood glucose before procedure, 2nd day, and two weeks later; HgA1C before, 3 and 6 months later; and MRI before and 6 months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Chronic low back pain; Moderate to severe pain score; Age 40-70 years; Inadequate response to conservative treatment; Disc protrusion. Exclusion criteria: Severe canal stenosis; Sequestrated disc; Sever spinal deformity;tumors;fracture); infection; Drug reaction; Sever psychological disorders; Pregnancy and lactation; Severe or sudden neurological deficit; Patient's dissatisfaction to participate the study.
Intervention groups
Intervention group1: receiving triamcinilone Intervention group2: receiving ropivacaine Control group: receiving magnesium sulfate and ropivacaine
Main outcome variables
Pain score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111102007984N29
Registration date: 2019-02-05, 1397/11/16
Registration timing: registered_while_recruiting

Last update: 2019-02-05, 1397/11/16
Update count: 0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
farnadimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison study of the effects of Triamcinolone and magnesium sulfate in caudal neuroplasty in chronic low back pain.
Public title
A comparison of the effects of Triamcinolone and magnesium sulfate in caudal neuroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic low back pain more than six months +/- radiculopathy Moderate to severe pain score (> 3, based on the Visual Analog Scale) Being at the age of 40-70 years Inadequate response to conservative and physiotherapy treatments after three months American Anesthesiologists Classification (ASA) I-II Disc protrusion in MRI
Exclusion criteria:
Severe canal stenosis (more than two thirds in axial MRI view) Sequestrated disc (fragmented) Decreased disc height more than 60% Sever spinal deformity Spinal tumors Vertebral fracture Spondylolisthesis Grade>2 Local or systemic infection Taking anticoagulants Drug abuse History of drug reaction Sever psychological disorders Pregnancy and lactation Severe or sudden neurological deficit such as urinary or fecal incontinence Body Mass Index (BMI) > 35 Patient's refusal Diabetes mellitus MRI contraindications (cardiac pacemaker, defibrillator, aortic aneurysm clips) Impossible prone positioning
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
By using the randomize number table, the patients were divided into two equal groups (n=25).
Blinding (investigator's opinion)
Double blinded
Blinding description
Both drugs are injectable and the injection site of both drugs in the patients' body is in the same area. Therefore, patients are not aware of the type of drug. Also, the outcome evaluator is unaware of the random allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Expressway corner
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-07-24, 1397/05/02
Ethics committee reference number
IR.IUMS.REC.1397.297

Health conditions studied

1

Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
low back pain
Timepoint
Before injection,two weeks,1,3 and 6 months after intervention
Method of measurement
pain score measured with visual analogue scale in Questionnaire.

Secondary outcomes

1

Description
Functional disability Index
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention
Method of measurement
Oswestry Disability Index questionnaire (ODI)

2

Description
Raising straight leg, raising straight leg reversely
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention
Method of measurement
straight leg raising test (SLR) ,Reverse straight leg raising test (RSLR)

3

Description
Bonnet
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention
Method of measurement
Questionnaire

4

Description
FABER
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention
Method of measurement
Questionnaire

5

Description
Gaenslen
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention
Method of measurement
Questionnaire

6

Description
Tiptoe and Heel walking
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention
Method of measurement
Questionnaire

7

Description
Visual Analogue Pain scale
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention
Method of measurement
Questionnaire

8

Description
Analgesic consumption
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention
Method of measurement
Questionnaire

9

Description
blood sugar
Timepoint
Blood sugar ,before injection,2 th day and 2th week after injection
Method of measurement
The result of the tests

10

Description
HbA1C
Timepoint
injectionHbA1C, before injection,3 and 6 month after injection
Method of measurement
The result of the tests

11

Description
Spinal canal diameter changes at MRI
Timepoint
MRI, before injection and 6 month after injection
Method of measurement
MRI report

Intervention groups

1

Description
In intervention group 10 ml Ropivacaine 0.2% ( produced by Molteni, Italy) ,10 cc Nacl 5%(produced by Samen, Iran) ,50 mg Magnesium sulfate (produced by Shahid Ghazi,Iran) and 1500 unit Hyalase(produced by Darupakhsh,Iran )was injected in the caudal epidural space by a Racz catheter (produced by Epimed,USA) under fluoroscopic guidance .
Category
Treatment - Drugs

2

Description
Control group: In control group 10 ml Ropivacaine 0.2% (produced by Molteni, Italy) ,10 cc Nacl 5%(produced by Samen,Iran) ,80 mg Triamcinolone (produced by Caspian, IRAN) and 1500 unit Hyalase(produced by Darupakhsh,Iran )was injected in the caudal epidural space by a Racz catheter (produced by Epimed,USA) under fluoroscopic guidance .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat- Rasul Akram Medical Coplex
Full name of responsible person
Farnad Imani
Street address
Anesthesiology and pain department of Hazrat-Rasoul Medical Complex, Niayesh street, Sattar-Khan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farnadimani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakoti
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Fax
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Interventional pain fellowship, professor of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Email
farnadimani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farnad Imani
Position
professor of anesthesiology,Interventional pain fellowship
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Email
farnadimani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Mirblook Jalali
Position
Head of Pain Research Center, Iran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh Street. Sattar Khan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Email
zmjalali56@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Some part of the clinical information of the patients will be shared
When the data will become available and for how long
6 months after the end of the project
To whom data/document is available
Faculty Members of Medical Sciences Universities
Under which criteria data/document could be used
For further studies
From where data/document is obtainable
Deputy of Research & Technology Pain Research Center, Iran University of Medical Sciences
What processes are involved for a request to access data/document
First, at the request of the university, she/he will be informed at the request of the university's deputy of the research department, and then she/he will be referred to the research center during the administrative process and the data will be received by the committee of the research center of the center with a commitment and acceptance.
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