Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Phase 2

Terminated

• Conditions: Osteoarthritis of the Knee
• Interventions: Other: placebo (saline); Other: ozone-oxygen mixture

• Registration Number: NCT00832312
• Lead Sponsor: Ben-Gurion University of the Negev

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.

Study Timeline

• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Study Start: 2009-08
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-28
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	placebo (saline)	Injection of 1cc of saline into the knee joint
ozone-oxygen mixture	ozone-oxygen mixture	10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint

Primary Outcome Measures

Name	Time	Method
Pain control	6 months

Trial Locations

Locations (1)

Ben Gurion University; 🇮🇱 Beer Sheva, Israel