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A comparison of the efficacy of transforaminal Triamcinolone and Magnesium sulfate injection in chronic low back pain.

Protocol summary

Summary
Objectives: Chronic radicular Low Back Pain is One of The Most Common Cause of Pain Clinic Admission Which is treated with Transforaminal Steroid Injection. Due to Steroid Injection Side Effects, We Decided to Compare Magnesium Sulfate Effects in This Study. Study design: Sample size is 30 patients. Patients with chronic low back pain which fulfill study criteria, randomly assigned into two groups by block randomization. The study will be done double – blinded in one center. Participation: inclusion criteria: radicular pain at least for 6 weeks, MRI findings, VAS>4, age between 20 and 70 years. Exclusion criteria: coagulopathy, local and systematic infections, allergic reaction to drugs, pregnancy, more than 3 pathologic levels and severe scoliosis. Intervention: Patients under local anesthesia and fluoroscopic guidance in prone position in operative room, transforaminal block will be done. In group 1, Ropivacaine 0.2%, 3cc with Triamcinolone 20 mg and in group 2, Ropivacaine 0.2% ,3cc with Magnesium Sulfate 150 mg will be injected. Visual analog scale (VAS), Oswestry disability Index (ODI), analgesic need, straight leg raise (SLR) will be checked as follow: before injection, 2 weeks later first, 3 and 6 months later. Fasting Blood Sugar (FBS) will be checked and Recorded as follow: before injection, 2 weeks later and first month later. Ca, Mg, Vit-C and Vit-D will be checked and Recorded as follow: before and 1 month later. The results will be analyzed and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306307984N10
Registration date: 2017-11-12, 1396/08/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-12, 1396/08/21
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
Vice Chancellor for Research and Technology of Iran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the efficacy of transforaminal Triamcinolone and Magnesium sulfate injection in chronic low back pain.
Public title
A comparison of the efficacy of transforaminal Triamcinolone and Magnesium sulfate injection in chronic low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Age 20-70 years 2. Pain at least 6 weeks 3. Evidence of Nerve root involvement as disc bulging and/or foraminal stenosis in CT/MRI 4. VAS > 4 5. ASA class I, II 6. Patients’ Informed consent Exclusion criteria: 1. Patients’ with coagulopathy 2. Infection in injection site as Herpetic diseases 3. Anatomical and congenital spine deformity as severe scoliosis 4. Surgical history instrument insertion 5. Psychological severe disorders 6. History of harmful reaction to local anesthetic and steroid. 7. Patients with motor deficit or progressive neural defect. 8. Cancer 9. Neural foramen radiological access difficulty 10. Substance abuse 11. HIV 12. Acute trauma 13. Cauda Equina syndrome 14. More than 3 level abnormalities 15. Absence of Inevitable radicular pain
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is double blinded. Patients and evaluators had no information about drug of injection.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences.
Street address
Iran university of medical science, Hemmat highway,Tehran
City
Tehran
Postal code
1445613131
Approval date
2016-09-10, 1395/06/20
Ethics committee reference number
IR.IUMS.REC.1395.27279

Health conditions studied

1

Description of health condition studied
chronic low back pain
ICD-10 code
G54.8
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
Patient performance is based on Oswestry Disability Index, and degree of Leg Raising is based on Straight Leg Raising Test, and possible complications will be recorded.
Timepoint
Before injection, two weeks, 1,3 and 6 moth after intervention.
Method of measurement
Questionnaire

Intervention groups

1

Description
In intervention group 3 ml 0.2% Ropivacaine (Ropivacaina Molteni, Molteni, Italy) plus 150 mg Magnesium Sulfate (Magnesium sulfate 50%, SAMEN, Iran) was injected in the selected level by a curved blunt tip 10 cm needle (Cosman, USA) under fluoroscopic guidance via transforaminal epidural approach.
Category
Treatment - Drugs

2

Description
In control group 3 ml 0.2% Ropivacaine (Ropivacaina Molteni, Molteni, Italy) plus 20 mg Triamcinolone (Triamcinolone acetonide, EXIR, IRAN) was injected in the selected level by a curved blunt tip 10 cm needle (Cosman, USA) under fluoroscopic guidance via transforaminal epidural approach.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Medical Center
Full name of responsible person
Dr Farnad Imani
Street address
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Iran University of Medical Sciences
Full name of responsible person
Dr Seyyed Ali Javad Mousavi
Street address
Hemmat Expressway, Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

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

Person responsible for scientific inquiries

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

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Poupak Rahimzadeh
Position
Anesthesiologist, Interventional pain fellowship,Associated professor of anesthesiology
Other areas of specialty/work
Street address
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
poupak_rah@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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