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Elastographic changes in para-spinal ozone therapy

Investigating the changes in the elastography of the para-spinal lumbar muscles on chronic low back pain patients after ozone injection

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190306042945N7
Enrollment
29
Registered
2025-08-28
Start date
2025-08-25
Completion date
Unknown
Last updated
2025-09-15

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 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

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaramarz Mahmoodi

Iran University of Medical Sciences

mahmoodi.faramarz@yahoo.com+98 21 3331 9653

Outcome results

None listed

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