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Evaluation of paraspinal ozone-oxygen therapy vs. pure oxygen injection, on chronic discogenic low back pain patients’ function and pain

Protocol summary

Study aim
The purpose of this study is that in the future, paraspinal ozone injection treatment can be used as a minimally invasive and non-surgical treatment to improve the symptoms of patients with chronic low back pain.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 20 patients. The rand function of Excel software was used for randomization.
Settings and conduct
20 patients clinically with the diagnosis of chronic discogenic low back pain , after ruling out other causes, , referred to the Physical Medicine and Rehabilitation Department of Firouzgar Hospital and met the inclusion criteria, will be included in the study. As primary data, the amount of pain and activity disorder of the patient will be collected from the patients through a questionnaire. Then, paraspinal ozone or oxygen injection intervention is performed and relevant follow-ups are performed. Gas mixture will prepared by another person, and with identical appearances in the case and control groups, blinding of the patient and the researcher will be considered.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with complaints of back pain that lasted for more than 3 months, disorder in at least one of the lumbosacral discs that is evident in the MRI. Exclusion criteria: Ozone therapy contraindications, neurological defects and canal stenosis at more than two levels.
Intervention groups
For the patients in the case group, paraspinal injection of the combination of ozone-oxygen gas with a certain dose is prescribed along with exercise training, and for the patients in the control group, paraspinal injection of pure medical oxygen gas is prescribed along with exercise training.
Main outcome variables
functional impairment of the patient according to the Oswestry Disability Index; Intensity of the patient's pain (using the Visual Analogue Scale)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190306042945N5
Registration date: 2024-08-29, 1403/06/08
Registration timing: prospective

Last update: 2024-08-29, 1403/06/08
Update count: 0
Registration date
2024-08-29, 1403/06/08
Registrant information
Name
Bijan Forogh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
forogh.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of paraspinal ozone-oxygen therapy vs. pure oxygen injection, on chronic discogenic low back pain patients’ function and pain
Public title
Comparison of paraspinal ozone vs. oxygen injection, on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with BMI less than 35 Complaint of low back pain (local or radicular) that has lasted for more than 3 months Pain intensity based on VAS should be higher than 4 Disorder in at least one of the lumbar spinal discs (L2-S1) that is evident in MRI The patient's willingness to participate in the research project
Exclusion criteria:
History of any lumbar spine surgery Receiving interventional treatments for back pain during the last six months The presence of ozone therapy contraindications (G6PD, sickle cell anemia, uncontrolled thyroid disorder, pregnancy, breastfeeding, uncontrolled hypoglycemia, etc.) The patient's back pain can be justified by any reason other than lumbar disc disorders Exacerbation of back pain in the patient with neurological defects such as weakness, loss of deep reflexes Occurrence of urinary and stool control disorders and numbness of the perineum Drug and alcohol addiction Patients with major depression or significant psychiatric and mental diseases (such as needle phobia, etc.) History of tumor or local infection of the lumbar region History of malignant diseases (multiple myeloma, bone metastases, leukemia and lymphoma) Use of medication or other treatment for back pain during the study Non-referral to record the desired scales during the follow-up period Presence of multilevel disc involvement and lumbar spinal canal stenosis in more than two levels
Age
From 45 years old to 60 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
After assigning a special code to each subject, the assignment of each code to the case or control group will be done randomly by someone other than the researcher and based on the random function of Excel software (even number = case and odd = control). For allocation concealment, based on the relevant code, the registration of patients in two control and sample groups will be done away from the reach of the researcher, and until after the end of the treatment and the analysis, the patient and the therapist will not know the type of treatment (ozone+oxygen or pure oxygen).
Blinding (investigator's opinion)
Double blinded
Blinding description
Regarding the double-blindness of this study, it should be noted that all patients receive apparently similar treatment (the appearance and details of the intervention are completely identical for the sample group and the control group) and despite the patient's knowledge of participating in the trial study, being in the control group or the sample group will not be known.
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, Iran University of Medical Sciences, Central Headquarters Building, Research and Technology Vice-Chancellor, next to Milad tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
IR.IUMS.REC.1403.313

Health conditions studied

1

Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Patient's pain intensity with Visual Analogue Scale
Timepoint
before, during the last intervention session, after one month and three months after completing three intervention sessions
Method of measurement
Completion of the Visual Analogue Scale by the patient

2

Description
Functional impairment of the patient based on the Oswestry Disability Index
Timepoint
before, during the last intervention session, after one month and three months after completing three intervention sessions
Method of measurement
Completion of the Oswestry Disability Index questionnaire by the patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Three sessions of paraspinal intramuscular injection of ozone with a dose of 20ug/ml and a volume of 5cc in each point, total four points, two points on each side at a distance of 2cm from the spinous process of the involved level based on MRI and with an interval of one week between each injection.
Category
Treatment - Drugs

2

Description
Control group: Three sessions of paraspinal intramuscular injection of oxygen gas with a volume of 5cc in each point, total four points, two points on each side at a distance of 2cm from the spinous process of the involved level based on MRI and with an interval of one week between each injection.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Bijan Forogh
Street address
Beh Afarin St., Karim Khan St., Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Email
bijanfr@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2703
Email
falak.r@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
Bijan Forogh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Behafarin Avenue, 1617763141, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 8214 1612
Fax
Email
forogh.b@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bijan Forogh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Behafarin Avenue, 1617763141, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 8214 1612
Fax
Email
forogh.b@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bijan Forogh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Behafarin Avenue, 1617763141, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 8214 1612
Fax
Email
forogh.b@iums.ac.ir

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individual ID data
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If needed, for use in future researches, please send a written request via email
From where data/document is obtainable
Main researcher: Dr. Bijan Forough Email: forogh.b@iums.ac.ir
What processes are involved for a request to access data/document
After sending the request to the e-mail, the information will be accessible within a period of about one week
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