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Randomized clinical trial ozone therapy on protruded lumbar disc herniation

Protocol summary

Study aim
1- Determine the change in pain intensity before and after ozone therapy 2- Determination of changes in the test of the lens before and after treatment with ozonotherapy 3- Comparison of two methods of treatment of cannosetics and ozone therapy in the treatment of lumbric disopathies
Design
Patients with acute low back pain created by lumbar disc herniation were randomly divided into two groups of control and recipients of muscle intramuscular injection of ozone
Settings and conduct
. All patients 2 weeks, 3 and 6 months after the end of treatment were evaluated clinically by VAS and the results of Chi - Square or Fisher exact test, Student t test will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criterias ; Acute low back pain with radiculopathy and the presence of a moderate to severe (5-10cm) Visual Analog Scale (VAS) on one leg and MRI indicating a protruded disc without degenerative disc.exclusion criteria ; Extruded discs, clinical signs of radiculopathy (reduction of tendon reflexes, muscle weakness, sensory impairment), horse tail syndrome, progressive neurological deficits, spinal cord stenosis. Spondylolisthesis, Previous Surgery; Diabetic Neuropathy , Body mass index greater than 30, lower back scoliosis more than 20 degrees; Lower limb length difference of more than 1.5 centimeters in simple radiography; pregnancy; and favism in which ozone therapy is contraindicated.Patients who have recently received ozone therapy.
Intervention groups
Injection of 250 micro grams of ozone in the disk space between the prosthetic disk Break the nucleotide proteoglycan so that the water is removed from the disk and the disk is collected and Oral administration of a non-steroidal anti-inflammatory drug Naproxen 500 mg every 12 hours and baculofen 10 mg muscle relaxant every 12 hours for 2 weeks.
Main outcome variables
paraverteal lumbar injection, which is associated with minimal invasion, seems to be in the elimination of pain, and It also reduces the inability and the use of analgesic drugs.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170727035336N1
Registration date: 2017-12-31, 1396/10/10
Registration timing: registered_while_recruiting

Last update: 2017-12-31, 1396/10/10
Update count: 0
Registration date
2017-12-31, 1396/10/10
Registrant information
Name
seyed reza javaheri
Name of organization / entity
tabriz medical science university
Country
Iran (Islamic Republic of)
Phone
+98 44 3384 8699
Email address
javaherir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
tabriz medical science university
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial ozone therapy on protruded lumbar disc herniation
Public title
Randomized clinical trial ozone therapy on protruded lumbar disc herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute low back pain with radiculopathy and the presence of a moderate to severe (5-10cm) Visual Analog Scale (VAS) on one leg and MRI indicating a protruded disc without degenerative disc
Exclusion criteria:
Extruded discs, clinical signs of radiculopathy (reduction of tendon reflexes, muscle weakness, sensory impairment), horse tail syndrome, progressive neurological deficits, spinal cord stenosis. Spondylolisthesis, Previous Surgery; Diabetic Neuropathy , Body mass index greater than 30, lower back scoliosis more than 20 degrees; Lower limb length difference of more than 1.5 centimeters in simple radiography; pregnancy; and favism in which ozone therapy is contraindicated.Patients who have recently received ozone therapy.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Tabriz Medical Science University
Street address
Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
57158-74746
Approval date
2017-07-10, 1396/04/19
Ethics committee reference number
IR.TBZMED.REC.1396.286

Health conditions studied

1

Description of health condition studied
Diseases of the nervous system
ICD-10 code
G50,G51,G5
ICD-10 code description
Nerve, nerve root and plexus disorders

Primary outcomes

1

Description
Changes in pain intensity and basal test before and after treatment of ozonotherapy
Timepoint
2 weeks, 3 and 6 months after treatment
Method of measurement
Clinical evaluation will be performed by the VAS (Pain Observation Scale)

Secondary outcomes

1

Description
The amount of analgesic use
Timepoint
2 weeks, 3 and 6 months after treatment
Method of measurement
Based on the dose of analgesic

Intervention groups

1

Description
Injection of 250 micrograms of ozone in the disk space between the prosthetic disk Break the nucleotide proteoglycan so that the water is removed from the disk and the disk is collected
Category
Treatment - Drugs

2

Description
Oral administration of a non-steroidal anti-inflammatory drug Naproxen 500 mg every 12 hours and bacullofen 10 mg muscle relaxant every 12 hours for 2 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Firooz Salehpoor MD
Street address
Imam Reza Hospital, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
57158-74746
Phone
+98 41 3334 0830
Email
firoozsalehpour@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Firooz Salehpoor MD
Street address
Vice chancellor for research, Medicine Faculty, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
57158-74746
Phone
+98 41 3334 3640
Email
firoozsalehpour@hotmail.com
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Reza Javaheri MD
Position
Neurosurgery Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Imam Reza Hospital, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
57158-74746
Phone
+98 41 3334 0830
Fax
+98 41 3335 2073
Email
javaherir@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz Medical Science University
Full name of responsible person
Firooz Salehpoor MD
Position
Neurosurgery Proffessor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Reza Hospital, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
57158-74746
Phone
+98 41 3334 0830
Fax
+98 41 3335 2073
Email
firoozsalehpour@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz Medical Science University
Full name of responsible person
Seyed Reza Javaheri MD
Position
Neurosurgery Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
57158-74746
Phone
+98 41 3334 0830
Fax
+98 41 3335 2073
Email
javaherir@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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