Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Ben-Gurion University of the Negev.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Howard Tandeter, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier:
NCT00832312
First received: January 29, 2009
Last updated: January 13, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Other: ozone-oxygen mixture
Other: placebo (saline)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Ben-Gurion University of the Negev:

Primary Outcome Measures:
  • Pain control [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832312

Contacts
Contact: Howard B Tandeter, MD 972-8-6477433 howard@bgu.ac.il

Locations
Israel
Ben Gurion University Recruiting
Beer Sheva, Israel, 84105
Principal Investigator: Howard B Tandeter, MD         
Sponsors and Collaborators
Ben-Gurion University of the Negev
Investigators
Principal Investigator: Howard B Tandeter, MD Ben GurionUniversity
  More Information

No publications provided

Responsible Party: Howard Tandeter, POB 653 Beer Sheva, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00832312     History of Changes
Other Study ID Numbers: 20080780
Study First Received: January 29, 2009
Last Updated: January 13, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Ben-Gurion University of the Negev:
Osteoarthritis
Knee
Pain management
Ozone therapy
Intraarticular injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014