The Effectiveness of Ultrasound Guided Ozone (O2-O3) Injection With Knee Osteoarthritis

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-04-15

Brief Summary

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Knee ostheoarthritis (KOA) is a common disabling and degenerative disease leading to painful joints, articular stiffness, and decreased function. The mechanism of the ozone of relieving the pain and improving the knee function is through inhibiting the inflammation reaction in the KOA directly. Actually, the ozone intra-articular injection had been used to relieve the pain caused by KOA.

The aim of this study is to evaluate the effect of intra-articular injection of medical ozone given into the knee of the osteoarthritis patients, and to compare it with intra-articular steroid injection and to investigate the effectiveness of ozone and steroid the job to determine the superiority of the injections to each other.

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Detailed Description

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The study was designed as prospective, randomized, controlled trial. 96 people who met the inclusion criteria were randomized into two groups of people. The first group will be designated as Ozone group will be applied to these patients. Patients in the second group will be designated as the steroid group, and injections will be applied in accordance with protocol. Participants were evaluated with Visual Analogue Scale (VAS), The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The presence of suprapatellar effusion of the participants whose evaluations are completed will be evaluated by ultrasonography and the findings will be recorded. Initial evaluations of the participants will be made before the first injection. Patients in the ozone (O2-O3) injection group will be given intraarticular and per-articular knee injections 3 times as the first dose of 10 μg / ml, the second dose is 15 μg / ml, and the third dose is 20 μg / ml, each session in a volume of 10 ml. In the steroid injection group, 1 ml of betamethasone (6 mg / ml) will be injected once intraarticular knee injection. Patients will be evaluated according to the study criteria at the beginning, 4 and 12 weeks later by a blinded investigator.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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medikal ozone group

medical ozone group patients diagnosed with knee ostheoarthritis

Group Type ACTIVE_COMPARATOR

Medical ozone injection

Intervention Type PROCEDURE

Patients in the ozone (O2-O3) injection group will be given intraarticular and periarticular knee injections 3 times as the first dose of 10 μg / ml, the second dose is 15 μg / ml, and the third dose is 20 μg / ml, each session in a volume of 10 ml. Patients will be evaluated according to the study criteria at the beginning, 4 and 12 weeks later by a blinded investigator.

steroid group

steroid group patients diagnosed with knee ostheoarthritis

Group Type OTHER

steroid injection group

Intervention Type PROCEDURE

In the steroid injection group, 1 ml of betamethasone (6 mg / ml) will be injected once intraarticular knee injection. Patients will be evaluated according to the study criteria at the beginning, 4 and 12 weeks later by a blinded investigator.

Interventions

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Medical ozone injection

Patients in the ozone (O2-O3) injection group will be given intraarticular and periarticular knee injections 3 times as the first dose of 10 μg / ml, the second dose is 15 μg / ml, and the third dose is 20 μg / ml, each session in a volume of 10 ml. Patients will be evaluated according to the study criteria at the beginning, 4 and 12 weeks later by a blinded investigator.

Intervention Type PROCEDURE

steroid injection group

In the steroid injection group, 1 ml of betamethasone (6 mg / ml) will be injected once intraarticular knee injection. Patients will be evaluated according to the study criteria at the beginning, 4 and 12 weeks later by a blinded investigator.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Female / male aged\> 45 years
2. Diagnosis of knee ostheoarthritis after physical examination and imaging (direct radiography)
3. Those whose symptoms persist\> 6 months
4. Radiological staging of osteoarthritis according to the Kellgren-Lawrence scale Grade 2 and 3
5. Participation in the study voluntarily and regularly

Exclusion Criteria

1. History of previous knee surgery
2. Patients with inflammatory arthritis (Rheumatoid arthritis, psoriatic arthritis, gouty arthritis as)
3. Patients with neuropathic pain
4. Those with pain reflected from the waist or hip
5. History of tumor, infectious, psychiatric illness, bleeding diathesis
6. Trauma history within the last 6 months
7. Hyaluronic acid or steroid injection in the last 3 months
8. Those with systemic diseases such as diabetes, rheumatoid arthritis, hepatitis, coagulopathy
9. Those with malignant hypertension
10. Those with G6PDH (Glucose 6-Phosphate Dehydrogenase) deficiency
11. Those with Graves' disease
12. Those with cerebrovascular event disease in which bleeding continues actively

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes