Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

Official title:

Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00832312
• Other study ID #: 20080780
• Status: Terminated
• Phase: Phase 2
• First received: January 29, 2009
• Last updated: July 27, 2016
• Start date: August 2009
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: Ben-Gurion University of the Negev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• ozone-oxygen mixture
10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)
• placebo (saline)
Injection of 1cc of saline into the knee joint

Locations

Country	Name	City	State
Israel	Ben Gurion University	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain control		6 months	No