Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis

NCT ID: NCT06328270

Last Updated: 2024-03-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group

The group received a 3-week intra-articular injection of 15 mg/ml ozone.

Group Type ACTIVE_COMPARATOR

Ozone - oxygen Therapy

Intervention Type OTHER

Ozone gas is a structurally unstable molecule that contains three oxygen atoms.

Control Group

The group received a 1 ml intra-articular injection of betamethasone

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type OTHER

1 ml betamethasone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ozone - oxygen Therapy

Ozone gas is a structurally unstable molecule that contains three oxygen atoms.

Intervention Type OTHER

Corticosteroid

1 ml betamethasone

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 40-85 years old,
* have experienced knee pain and/or limited joint range of motion for at least 6 months,
* have a diagnosis of KOA supported by radiographic imaging.

Exclusion Criteria

* patients had undergone knee joint surgery,
* had a history of previous intra-articular injections,
* had any rheumatological disease or malignancy,
* being pregnant,
* had pain radiating to the knee and leg.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aylin Ayyıldız

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

03.09.2019 / 2505

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Knee OsteoArthritis Long-term Assessment
NCT06839222 NOT_YET_RECRUITING NA