Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ozone-oxygen mixture

10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint

Group Type EXPERIMENTAL

ozone-oxygen mixture

Intervention Type OTHER

10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)

Saline

Injection of 1cc of saline into the knee joint

Group Type PLACEBO_COMPARATOR

placebo (saline)

Intervention Type OTHER

Injection of 1cc of saline into the knee joint

Interventions

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ozone-oxygen mixture

10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)

Intervention Type OTHER

placebo (saline)

Injection of 1cc of saline into the knee joint

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No