Protocol summary

Summary
In this clinical trial, 40 patients with radiating low back pain to the lower limbs were selected .they had been diagnosed as disc herniation in physical exam and lumbar spinal disc imaging . The patients were randomly divided into two equal groups for intradiscal interventions. 20 patients in the laser group (L) was irradiated 1500 J Laser ray inters Disc. 20 patients in the ozone Group: (O) volume of 6 mL of 30 micrograms ozone, was injected into the disc. In both groups, 20 mg of triamcinolone was injected by transforaminal approach around the involved nerve root. Patients were followed for pain score on the visual Analog Scale (VAS) and improved performance in life based on Oswestry disability index and satisfaction levels, for six months

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011910599N7
Registration date: 2016-07-30, 1395/05/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University Of Medical School
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2016-04-03, 1395/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of interadiscal ozone injection and Laser disc decompression in discogenic low back pain
Public title
Comparison of the efficacy of interadiscal ozone injection and Laser disc decompression in discogenic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :age 20 -70 ,ASA(American Society of Anesthesia ) I,II ,root irritation secondary to herniated disc ,pain score more than 4 , valid consent Exclusion criteria ; disc sequestration ,involve more than two disc ,cuda equina syndrome ,favism in ozone group
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: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University Of Medical School
Street address
Hemmat exp way
City
tehran
Postal code
Approval date
2016-06-01, 1395/03/12
Ethics committee reference number
IR.IUMS.REC.1395.27280

Health conditions studied

1

Description of health condition studied
Low Back Pain
ICD-10 code
G55.1
ICD-10 code description
Nerve root and plexus compressions in intervertebral disc disorders

Primary outcomes

1

Description
reduce pain & disability
Timepoint
one week ,1,3 ,6 month
Method of measurement
( visual analogue scale(VAS) , Oswestry disability index(ODI)

Secondary outcomes

1

Description
satisfactory ratio
Timepoint
6 month
Method of measurement
Patient relief

Intervention groups

1

Description
Ineradiscal 1500 J laser beam
Category
Treatment - Surgery

2

Description
ozone 30 mic interadiscal 6 ml injected
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasol Akram Hospital
Full name of responsible person
Mohmad Ghahremani MD
Street address
Satar Chan Ave ,Niaish St
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chanceller of Research ,Iran University of medical Sciences
Full name of responsible person
Dr Musavi
Street address
Hemat l Exp Way,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 Chanceller of Research ,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
Pain Research Center
Full name of responsible person
Mohamad Ghahermani MD
Position
Pain Fellowship
Other areas of specialty/work
Street address
Rasuol Akram Hospital
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
dr.m.ghahremani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pain Research Center
Full name of responsible person
Poupak Rahimzadeh MD
Position
Associate Professor
Other areas of specialty/work
Street address
Rasol Akram Hospital
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
poupak_rah@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Pain Research Center
Full name of responsible person
Poupak Rahimzadeh MD
Position
Associate Professor
Other areas of specialty/work
Street address
Rasoul Akram Hospital
City
Tehran
Postal code
Phone
+98 21 64351
Fax
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
empty
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