Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

• ClinicalTrials.gov Identifier: NCT00832312
• Recruitment Status: Terminated
• First Posted: January 30, 2009
• Last Update Posted: July 28, 2016
• Sponsor: Ben-Gurion University of the Negev
• Information provided by (Responsible Party): Howard Tandeter, Ben-Gurion University of the Negev

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis of the Knee	Other: ozone-oxygen mixture; Other: placebo (saline)	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
• Study Start Date: August 2009
• Actual Primary Completion Date: July 2016
• Estimated Study Completion Date: August 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Pain control [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Israel

Ben Gurion University

Beer Sheva, Israel, 84105

Sponsors and Collaborators

Ben-Gurion University of the Negev

Investigators

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

More Information

• Responsible Party: Howard Tandeter, POB 653 Beer Sheva, Ben-Gurion University of the Negev
• ClinicalTrials.gov Identifier: NCT00832312
• Other Study ID Numbers: 20080780
• First Posted: January 30, 2009
• Last Update Posted: July 28, 2016
• Last Verified: July 2016

Keywords provided by Howard Tandeter, 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