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Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

This study has been terminated.
(Because of technical problems (researcher moved to different city).)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00832312
First Posted: January 30, 2009
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Howard Tandeter, Ben-Gurion University of the Negev
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain control [ Time Frame: 6 months ]

Enrollment: 20
Study Start Date: August 2009
Estimated Study Completion Date: August 2016
Primary Completion Date: July 2016 (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

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832312


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     History of Changes
Other Study ID Numbers: 20080780
First Submitted: January 29, 2009
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