Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

July 27, 2016 updated by: Howard Tandeter, Ben-Gurion University of the Negev
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel, 84105
        • Ben Gurion University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain control
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ben-Gurion University of the Negev

Investigators

  • Principal Investigator: Howard B Tandeter, MD, Ben GurionUniversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

July 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080780

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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