Evaluation of the efficacy of ozone therapy on the treatment of patients with lumbar disc herniation
Design
Randomize clinical trial with control group
Settings and conduct
Patients who are candidates for ozone therapy are hospitalized and Ozone is injected in fluoroscopic guidance in the operation room
Participants/Inclusion and exclusion criteria
Patients with lumbar disc herniation who do not currently have canal Stenosis And they did not respond to non-intervention therapy
Intervention groups
Ozone therapy in the intervention group
Exercise Therapy in the Control Group
Main outcome variables
Pain; function; disc regression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200118046174N1
Registration date:2020-03-20, 1399/01/01
Registration timing:registered_while_recruiting
Last update:2020-03-20, 1399/01/01
Update count:0
Registration date
2020-03-20, 1399/01/01
Registrant information
Name
Hossein Shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1297
Email address
dr_hshafiei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ozone therapy on pain and function of patients with lumbar disc herniation
Public title
The effect of ozone gas on lower back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lumbar disc herniation
Exclusion criteria:
Spinal Stenosis
History of surgery in the Spine area
History of malignancy in the Spine area
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the fact that the treatment was different in the two intervention and control groups, there was no possibility of blinding the participants.
Physician helping patients fill out questionnaires and the Physician who checks the MRI blinded.
The analyzer was also blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
First floor Building No. 4 Sina Hospital Imam Khomeini Hospita
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.274
Health conditions studied
1
Description of health condition studied
Back Pain; Lumbar disc - Lumbar disc herniation
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region
Primary outcomes
1
Description
Pain
Timepoint
In baseline, 2 weeks 1 month and 3 months after ozone injection
Method of measurement
Visual Analogue Scale
2
Description
Function
Timepoint
In baseline and 3 months after ozone injection
Method of measurement
Sf36
3
Description
Regression of herniated disc
Timepoint
In baseline and 3 months after ozone injection
Method of measurement
MSU Classification
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of ozone at a concentration of 40 mg / DL in the operating room
Category
Treatment - Drugs
2
Description
Control group: Physiotherapy and drug treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Farhad Mahdavi
Street address
First floor Building No. 4 Sina Hospital Imam Khomeini
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6312 1297
Email
fmahdavi075@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Sahraian
Street address
Imam Khomeini Ave Sina Hospital Orthopedic Department
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6312 1297
Email
farhadmahdavi6889@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
1
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
Tehran University of Medical Sciences
Full name of responsible person
Farhad Mahdavi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Ave Sina Hospital Orthopedic Department
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6312 1297
Email
farhadmahdavi6889@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Mahdavi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Ave; Sina Hospital Orthopedic Department
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
63121297
Email
farhadmahdavi6889@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Mahdavi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Ave Sina Hospital Orthopedic Department
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
63121297
Email
farhadmahdavi6889@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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All the study database will be accessible except the participants personal data.
When the data will become available and for how long
The database will be accessible 6 months after result publication
To whom data/document is available
The database will be accessible for academic researchers
Under which criteria data/document could be used
Use of database in academic researches is permitted by reference to the source
From where data/document is obtainable
For database access the request must be sent to farhadmahdavi6889@gmail.com
What processes are involved for a request to access data/document
Upon sending an email the request will be reviewed by the hospital research center and will be sent to the applicant academic research center immediately after verification of the identity.