Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an intraarticular injection of Ozone into the knee joint is an effective therapy for pain control in patients with osteoarthritis of the knee.

Detailed Description
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Ozone, as a gas made of three atoms of oxygen with a cyclic structure, has been used as a medical therapy from the mid ninetieth century. Today, this therapy is a recognized modality in many European and Latin American nations for orthopedic problems, infections, ischemic diseases, and skin problems. However, despite of this wide use internationally, there is minimal mention of this treatment modality in the Anglo-American literature. The present is the first of a series of studies planned to scientifically test the effectiveness of ozone as a main-stream therapy, introducing it to the Anglo-American literature. In this first study we will check whether intraarticular injections of Ozone into the knee joint are effective as a therapy for pain control in patients with osteoarthritis of the knee.

Official Title
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Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Other: ozone-oxygen mixture
* Other: placebo (saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Osteoarthritis of knee Exclusion Criteria: Positive rheumatologic serologic tests Cognitive impairment Adjacent osteomyelitis Bacteremia Hemarthrosis Impending (scheduled within days) joint replacement surgery Infectious arthritis Joint prosthesis Osteochondral fracture Periarticular cellulitis Poorly controlled diabetes mellitus Uncontrolled bleeding disorder or coagulopathy.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ozone-oxygen mixture<br>10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint | Other: ozone-oxygen mixture<br>* 10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)<br>|
| Placebo Comparator: Saline<br>Injection of 1cc of saline into the knee joint | Other: placebo (saline)<br>* Injection of 1cc of saline into the knee joint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Pain management, Ozone therapy, Intraarticular injection