Comparison of ozone effect on knee osteoarthritis

Phase 2

Conditions: Primery gonrthrosis,bilatral.
Bilateral primary osteoarthritis of knee
M17.0

Registration Number: IRCT20151017024572N18

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

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 old
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.

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 questioner.;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.;Side effects. Timepoint: one, four weeks after. Method of measurement: Physical examination.

Secondary Outcome Measures