The purpose of this study is whether injection of ozone into the lumbar para-spinal muscles causes muscular tissue changes.
Design
Clinical trial without control group, before-after study, unblinded, non-randomized, phase 2 on 29 patients.
Settings and conduct
Twenty-nine patients who present to the Rasoul Akram Hospital Physical Medicine and Rehabilitation Department with a clinical diagnosis of chronic low back pain, after exclusion of other causes, and who meet the study inclusion criteria, will be enrolled after providing written informed consent. Initially, baseline data including the patient’s pain level and functional impairment will be collected using a questionnaire. Paraspinal muscle elastosonography will then be performed and recorded, followed by paraspinal ozone injection at the same site, and appropriate follow-up will be conducted.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with complaints of back pain that lasted for more than 3 months.
Exclusion criteria: Ozone therapy contraindications, neurological defects.
Intervention groups
For patients presenting with low back pain, elastosonography of the paraspinal muscles is first performed. Then, a paraspinal injection of ozone gas with a certain dose is administered at the target site
Main outcome variables
Intensity of the patient's pain (using the Visual Analogue Scale)
Muscular tissue changes (based on elastosonography report)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190306042945N7
Registration date:2025-08-28, 1404/06/06
Registration timing:registered_while_recruiting
Last update:2025-08-28, 1404/06/06
Update count:0
Registration date
2025-08-28, 1404/06/06
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
2025-08-25, 1404/06/03
Expected recruitment end date
2026-03-06, 1404/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the changes in the elastography of the para-spinal lumbar muscles on chronic low back pain patients after ozone injection
Public title
Elastographic changes in para-spinal ozone therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's willingness to participate in the research project
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
Patients with BMI less than 35
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.)
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)
Non-referral to record the desired scales during the follow-up period
Occurrence of urinary and stool control disorders and numbness of the perineum
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
29
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 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
2024-05-15, 1403/02/26
Ethics committee reference number
IR.IUMS.FMD.REC.1403.128
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 injection, one week after injection, two weeks after injection, one month after injection
Method of measurement
Completion of the Visual Analogue Scale by the patient
2
Description
Muscle tissue changes (based on elastosonography report)
Timepoint
Before injection, one week after injection, two weeks after injection, one month after injection
Method of measurement
Recording ultrasound elastography values using an ultrasound device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pain-area elastography of the lower back to identify the injection point, then one session of para-spinal intramuscular ozone injection at a concentration of 20 µg/ml and a volume of 5 cc, given 2 cm from the spinous process of the involved level, followed by elastography follow-ups at one week, two weeks, and one month after the injection.
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
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?