A Comparative Study of the Efficacy of Ozone Injection with Two Doses and Oxygen Injection on Pain and Physical Function of Patients with Radicular Low back pain: A Controlled Randomized Trial with A six-Month Follow –up
Evaluation of ozone injection in two different Doses compared to oxygen on pain and performance improvement in patients with low back pain (LBP)
Design
Phase 3 double-blind randomized clinical trial (RCT) with parallel groups of patients with clinical signs of radicular LBP, randomized to 54 patients using PASS 11 software from the Means menu below Menu one way ANOVA
Settings and conduct
If the patient eligible,he is included in the study. the research checklist and the results of the research will be evaluated for the patient and the information obtained from the record will be collected.
Patients are selected from the clients of the Rasool Akram Hospital Sports Medicine Clinic in 1402(2023) . The patient will be evaluated before the first and after the intervention sessions (tenth intervention session), 3 and 6 months later.
Patients will be randomly divided into three treatment groups. The first group contains 10 cc of drug with 40 μg / ml ozone in the O2O3 composition, the second group 10 cc of O2O3 composition with a concentration of 20 μg / ml and the third group 10 cc of pure O2 at each point (BL23 , 24.25 points acupuncture) and will receive on both sides.
Participants/Inclusion and exclusion criteria
Patients with diffuse LBP with at least pain intensity 4 according to VAS criteria
At least 1 month of LBP
Failure to respond to supportive therapy
Age 30-60 years old
Patients with BMI 20-35
MRI based on the presence of a disc herniation which location is associated with symptoms
Intervention groups
Group of patients receiving a dose of 40 micro grams per ml of ozone
Group of patients receiving a dose of 20 micro grams per ml of ozone
Group of patients receiving pure oxygen or O2 group
Main outcome variables
back pain, functional tests, disability due to pain (ODI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211116053072N1
Registration date:2023-05-31, 1402/03/10
Registration timing:prospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Hooman Angoorani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8827 1703
Email address
angoorani.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of the Efficacy of Ozone Injection with Two Doses and Oxygen Injection on Pain and Physical Function of Patients with Radicular Low back pain: A Controlled Randomized Trial with A six-Month Follow –up
Public title
Study of the Efficacy of Ozone Injection on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diffuse low back pain with minimal pain intensity 4 according to VAS criteria
At least 1 month of low back pain
Failure to respond to supportive therapy (such as medication or physiotherapy)
Age 30-60 years old
Patients with body mass index 20-35
MRI based on the presence of a disc herniation whose location is associated with symptoms
Exclusion criteria:
Previous spinal surgery
Bone lesions of the spine or spinal cord
History of receiving ozone or topical injection of any other drug
Pregnancy
Spinal cord diseases
Uncontrolled diabetes
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The list of random allocation of patients will be done individually and in treatment groups randomly using random blocks of 3 volume
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, primary evaluators, interveners and collectors of results and analysts are blind to the study
Placebo
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