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A comparison of the effects of Triamcinolone and Dexmedetomidine in caudal neuroplasty in chronic low back pain.

Protocol summary

Study aim
Comparative study of triamcinolone and dexmedetomodine in caudal neuroplasty in chronic low back pain
Design
Fifty patients will be randomly assigned into two groups of 25. Intervention group receives Dexmedetomidine, and control group receiving triamcinolone for caudal neuroplasty.
Settings and conduct
The aim of this study is comparison of triamcinolone and Dexmedetomidine for caudal neuroplasty. Fifty patients with lumbar radiculopathy were randomly divided into two groups. In the first group, triamcinolone (80 mg), and in the 2nd group, magnesium (50 mg) were injected into the caudal space. In the 2nd day, the same drug was injected into the catheter by half a day via 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 6months later, and, MRI before and 6months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1) Chronic low back pain, 2) Moderate to severe pain score, 3) Age 40-70 years, 4) Inadequate response to conservative, 5) Disc protrusion Exclusion criteria: 1) Severe canal stenosis, 2) Sequestrated disc, 3) Sever spinal deformity, tumors, and fracture, 4) infection, 5) Drug reaction, 6) Sever psychological disorders,7) Pregnancy and lactation, 8) Severe or sudden neurological deficit, 9) Patient's refusal
Intervention groups
En Ist group received triamcinilone and ropivacaine 2nd group received Dexmedetomidine and ropivacaine
Main outcome variables
Pain score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111102007984N28
Registration date: 2018-12-17, 1397/09/26
Registration timing: registered_while_recruiting

Last update: 2018-12-17, 1397/09/26
Update count: 0
Registration date
2018-12-17, 1397/09/26
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 of the effects of Triamcinolone and Dexmedetomidine in caudal neuroplasty in chronic low back pain.
Public title
A comparison of the effects of Triamcinolone and Dexmedetomidine in caudal neuroplasty in chronic low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Chronic low back pain more than six months +/- radiculopathy, 2) Moderate to severe pain score (> 3, based on the Visual Analog Scale),3) Age 40-70 years,4) Inadequate response to conservative and physiotherapy treatments after three months,5) ASA classification I-II,6) Disc protrusion (at MRI)
Exclusion criteria:
1) Severe canal stenosis (more than two thirds in axial MRI view), 2) Sequestrated disc (fragmented),3) Decreased disc height more than 60%,4) Sever spinal deformity,5) Spinal tumors,6) Vertebral fracture,7) Spondylolisthesis > Grade II, 8) Local or systemic infection, 9) Taking anticoagulants,10) Drug abuse,11) History of drug reaction,12) Sever psychological disorders,13) Pregnancy and lactation,14) Severe or sudden neurological deficit such as urinary or fecal incontinence,15) Body Mass Index (BMI) > 35,16) Patient's refusal,17) Diabetes mellitus, 18) MRI contraindications (cardiac pacemaker, defibrillator, aortic aneurysm clips),19)Impossible prone positioning
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
En By using the randomized table, they were divided into two equal groups (n=25). The first group (TR) received triamcinolone plus ropivacaine, and the second group (MR) received Dexmedetomidine plus ropivacaine. for caudal neuroplasty.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both 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 drug. Also, the outcome evaluator is unaware of how 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
2018-07-25, 1397/05/03
Ethics committee reference number
IR.IUMS.REC.1397.298

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 month after intervention
Method of measurement
pain score measured with visual analogue scale in Questionnaire

Secondary outcomes

1

Description
Oswestry Disability Index questionnaire (ODI) and straight leg raising test (SLR), Reverse straight leg raising test (RSLR),Bonnet,FABER,Gaenslen,Tiptoe and Heel walking,analgesic consumption,blood sugar,HbA1C,MRI
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention. Blood sugar ,before injection,2 th day and 2th week after injectionHbA1C, before injection,3 and 6 month after injection MRI, before injection and 6 month after injection
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: In intervention group 10ml Ropivacaine 0.2%, 50mg Dexmedetomidine (Excir, Iran) and was injected in the caudal epidural space by a catheter under fluoroscopy.
Category
Treatment - Drugs

2

Description
In control group 10ml 0.2% Ropivacaine (Molteni, Italy), 80 mg Triamcinolone (Caspian, IRAN) was injected in the caudal epidural space by a catheter under fluoroscopy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Medical Center
Full name of responsible person
Farnad Imani
Street address
Anesthesiology and pain department of Hzrat-Rasoul Medical Complex Niayesh street, sattar-Khan Avenue.
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
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
Specialist
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
Web page address

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
Specialist
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 St. Sattar Khan St
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
Part of the clinical information of the patient is 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 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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