Compare the effect of ozone injection with corticosteroid injection on osteoarthritis of the knee

Phase 3

• Conditions: Primary gonarthrosis, bilatera.; Primary gonarthrosis, bilateral

• Registration Number: IRCT2016112724572N3
• Lead Sponsor: Vice President of Research Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

patients with mild to moderate OA of the knee (Kellgren Lawrence grade I, II and III); Knee pain for at least six months; Age 40 to 75 years; the absence of any acute or chronic infection; no pregnancy or lack of planning to get pregnant; no history of any intra articular knee injection in three months ago; The absence of inflammatory articular disease or secondary osteoarthritis; no history of knee surgery (3 months ago); no severe underlying disease such as uncontrolled diabetes; use of anticoagulants; lack of daily use of opioid and non opioid analgesics; absence of contraindications of ozone therapy (deficiency G6PD, uncontrolled hyperthyroidism, leukemia).
Exclusion criteria: the willingness of patients to exit from the study at any stage of the study; not coming patients for follow up and evaluation during the follow up period; daily use of any type of analgesic medication by patients during the follow up period; occurring a pathology in the knee, such as meniscus tear during the follow up period; occurring 4th and 7th inclusion criteria, during the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of pain. Timepoint: Zero, one, four and twelve weeks after. Method of measurement: Visual Analog Scale(VAS).;The severity of symptoms and functional limitations. Timepoint: Zero, one, four and twelve weeks after. Method of measurement: By using WOMAC questionnare.;Sonographic criteria (efusion). Timepoint: Zero, one, four and twelve weeks after. Method of measurement: By using sonographic device.;Range of motion. Timepoint: Zero, one, four and twelve weeks after. Method of measurement: Goniometer.

Secondary Outcome Measures

Name	Time	Method
Side effects. Timepoint: One and four weeks after. Method of measurement: Physical examination.