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A comparison between effectiveness of intramuscular ozone gas injection in paravertebral muscles with subcutaneous ozone gas injection in patients with lumbosacral spinal canal stenosis - a randomized clinical trail

A comparison between effectiveness of intramuscular ozone gas injection in paravertebral muscles with subcutaneous ozone gas injection in patients with lumbosacral spinal canal stenosis - a randomized clinical trail

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230701058636N1
Enrollment
36
Registered
2023-10-11
Start date
2023-10-23
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Lumbosacral spinal stenosis. Lumbosacral spinal stenosis

Interventions

Intervention 1: Intervention group : including subcutaneous injection of 2 cc of 25 ml/ug ozone gas in the area of back pain at an angle of 45-degree to the sagittal plate whit 25-gage needle, for thr

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: Completion and signing of the consent form Presence of pain and other clinical symptoms of lumbar sacral stenosis in the last six months that did not respond to conservative treatments. Age between 75-35 years old Absence of any disease around the spine

Exclusion criteria

Exclusion criteria: Favism Infection involving lumbar spinal (brucella) Diabetes mellitus, Rhumatological disorder (lupuse, gout) BMI more than 41 Pregnancy Malignancy Liver disease Sensitivity reaction to test drug Malnutrition Peripheral neuropathy Bleeding disorder Galactosemia Radiculopathy Inability to communicate and complete questionnaires

Design outcomes

Primary

MeasureTime frame
Pain score according to Visual Analog Scale. Timepoint: At baseline (before intervention), 2, 4 and 8 weeks after injection. Method of measurement: Visual Analog Scale.;Patient Performance Score in Oswestry Disability Scale. Timepoint: At baseline (before intervention), 2, 4 and 8 weeks after injection. Method of measurement: Oswestry Low Back Pain Questionnaire.;Patient Performance Score in QUEBEC Back Pain Disability. Timepoint: At baseline (before intervention), 2, 4 and 8 weeks after injection. Method of measurement: QUEBEC Back Pain Disability Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhazaleh Rezaeianpour

Shiraz University of Medical Sciences

ghazalrzpdr@gmail.com1017 773 919 98+

Outcome results

None listed

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