Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Ben-Gurion University of the Negev

Status and phase: Terminated; Phase 2

Conditions: Osteoarthritis of the Knee

Treatments: Other: ozone-oxygen mixture; Other: placebo (saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT00832312

20080780

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

ozone-oxygen mixture

Experimental group

Description:

10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint

Treatment:

Other: ozone-oxygen mixture

Saline

Placebo Comparator group

Description:

Injection of 1cc of saline into the knee joint

Treatment:

Other: placebo (saline)