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

NCT04830423 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-03-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    lead OTHER

Principal Investigators

  • Sefa Gümrük Aslan · Gaziler Physical Medicine And Rehabilitation Health Application And Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-04-15
Completion
2022-04-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04830423 on ClinicalTrials.gov