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

March 15, 2022 updated by: Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

The Effectiveness of Ultrasound Guided Intraarticular and Periarticular Ozone (O2-O3) Injection in the Treatment of Patients With Knee Osteoarthritis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: medikal ozone group
medical ozone group patients diagnosed with knee ostheoarthritis
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.
Other: steroid group
steroid group patients diagnosed with knee ostheoarthritis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAIN - Numerical Rating Scale (NRS)
Time Frame: up to 12 weeks
Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Severity of pain was assessed NRS using the standard 10 cm (at rest, at motion and at night) with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end.
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life - Short Form-36 (SF-36)
Time Frame: initial, 4th week 12th week pain change
Satisfaction assessed by the SF-36. Short Form (SF-36) was used to investigate the quality of life of the patients.The reliability and validity of the Turkishversion of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores show better Quality of life.
initial, 4th week 12th week pain change
PAIN, PHYSICAL FUNCTION -Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: initial, 4th week 12th week pain change
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:Pain, Stiffness and Physical Function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
initial, 4th week 12th week pain change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Principal Investigator: Sefa gümrük aslan, Gaziler Physical Medicine And Rehabilitation Health Application And Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

April 15, 2022

Study Completion (Anticipated)

April 15, 2022

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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