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Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

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

Tracking Information
First Submitted Date  ICMJE January 29, 2009
First Posted Date  ICMJE January 30, 2009
Last Update Posted Date July 28, 2016
Study Start Date  ICMJE August 2009
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2009)
Pain control [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
Official Title  ICMJE Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of the Knee
Intervention  ICMJE
  • Other: ozone-oxygen mixture
    10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)
  • Other: placebo (saline)
    Injection of 1cc of saline into the knee joint
Study Arms  ICMJE
  • 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
    Intervention: Other: ozone-oxygen mixture
  • Placebo Comparator: Saline
    Injection of 1cc of saline into the knee joint
    Intervention: Other: placebo (saline)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 7, 2010)
20
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00832312
Other Study ID Numbers  ICMJE 20080780
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Howard Tandeter, Ben-Gurion University of the Negev
Study Sponsor  ICMJE Ben-Gurion University of the Negev
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Howard B Tandeter, MD Ben GurionUniversity
PRS Account Ben-Gurion University of the Negev
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP