Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis of the Knee
Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
ozone-oxygen mixture
placebo (saline)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Knee, Pain management, Ozone therapy, Intraarticular injection
Eligibility 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.
Sites / Locations
- Ben Gurion University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ozone-oxygen mixture
Saline
Arm Description
10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint
Injection of 1cc of saline into the knee joint
Outcomes
Primary Outcome Measures
Pain control
Secondary Outcome Measures
Full Information
NCT ID
NCT00832312
First Posted
January 29, 2009
Last Updated
July 27, 2016
Sponsor
Ben-Gurion University of the Negev
1. Study Identification
Unique Protocol Identification Number
NCT00832312
Brief Title
Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
Official Title
Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Because of technical problems (researcher moved to different city).
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ben-Gurion University of the Negev
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis, Knee, Pain management, Ozone therapy, Intraarticular injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ozone-oxygen mixture
Arm Type
Experimental
Arm Description
10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Injection of 1cc of saline into the knee joint
Intervention Type
Other
Intervention Name(s)
ozone-oxygen mixture
Intervention Description
10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)
Intervention Type
Other
Intervention Name(s)
placebo (saline)
Intervention Description
Injection of 1cc of saline into the knee joint
Primary Outcome Measure Information:
Title
Pain control
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard B Tandeter, MD
Organizational Affiliation
Ben GurionUniversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ben Gurion University
City
Beer Sheva
ZIP/Postal Code
84105
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
We'll reach out to this number within 24 hrs