Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
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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 |
- 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 |
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| Contact: Howard B Tandeter, MD | 972-8-6477433 | howard@bgu.ac.il |
| Israel | |
| Ben Gurion University | Recruiting |
| Beer Sheva, Israel, 84105 | |
| Principal Investigator: Howard B Tandeter, MD | |
| 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 May 21, 2013