The effect of ozone injection with two different injection methods to control knee pai

Phase 2

Recruiting

Conditions: Knee Osteoartritis.
Unilateral primary osteoarthritis, unspecified knee
M17.10

Registration Number: IRCT20131124015515N5

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients older than 40 years
The pain of knee osteoarthritis for more than three months
Radiological findings confirming knee osteoarthritis based on the American College of Rheumatology
Osteoarthritis with Grade II-III based on Kellgren-Lawrence radiology grading
No effusion
Signed written informed consent to participate in the study

Exclusion Criteria

Patients with history of knee surgery
Deformity and lower limb contraction
Lower limb neovascular disease
Acute lumbosacral pathology
Injection of steroid drugs over the past two months
History of inflammatory rheumatoid arthritis
Infection
Diabetes
Pregnancy
Breast feeding
Body Mass Index >35 kg/m2
Patients undergoing knee surgery
Knee deviation (verrucous or valgus more than 5 degrees) confirmed by three joint view
Radicular pain
Knee pain
Anticoagulant therapy
Post-traumatic arthritis
History of intraArticular or ozone therapy during 12 Last month
Systemic or psychiatric illness
Severe osteoarthritis with Grade over III

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Level by visual analog scale. Timepoint: In the portal area during the first, second, third and fourth injections and knee pain before treatment, one month and three months after the last injection. Method of measurement: Visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe).;Disability Level by Oswestry Low Back Disability Questionnaire. Timepoint: Before starting treatment and three months after the last injection. Method of measurement: Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability.

Secondary Outcome Measures