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

Not Applicable

• Conditions: umbosacral spinal stenosis.; Lumbosacral spinal stenosis; M48.06

• Registration Number: IRCT20230701058636N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 36

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.