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Comparison of paraspinal ozone vs. oxygen injection, on low back pain

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190306042945N5
Enrollment
20
Registered
2024-08-29
Start date
2024-09-22
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic low back pain. Low back pain

Interventions

Intervention 1: 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 a

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 60 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBijan Forogh

Iran University of Medical Sciences

forogh.b@iums.ac.ir+98 21 8214 1612

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026