Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00832312

Enrollment

Registered

2009-01-30

Start date

2009-08-31

Completion date

2016-08-31

Last updated

2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis, Knee, Pain management, Ozone therapy, Intraarticular injection

Brief summary

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

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.

Interventions

OTHERozone-oxygen mixture

10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)

OTHERplacebo (saline)

Injection of 1cc of saline into the knee joint

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pain control	6 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026