Different Ozone Concentrations for Knee Osteoarthritis

Sakarya University159 enrolled

Overview

Knee osteoarthritis is a common condition that causes pain, stiffness, and difficulty with daily activities. Ozone injection therapy is a minimally invasive treatment that has been increasingly used to relieve symptoms in people with knee osteoarthritis. However, it is not clear whether different ozone concentrations produce different treatment outcomes. In this study, we compared the effects of two commonly used ozone concentrations (15 μg/mL and 25 μg/mL) in patients with knee osteoarthritis. A total of 159 patients received intra-articular ozone injections and were followed for 3 months. Pain, physical function, and quality of life were assessed before treatment and at 1 and 3 months after the injections.

Background: Knee osteoarthritis (KOA) is a prevalent joint disorder globally, resulting in pain and disability, with various treatment options available. Intra-articular ozone (O2-O3) administrations are an efficient therapeutic approach commonly employed in this condition. With this study, we aimed to compare the effect of varying ozone concentrations on treatment outcomes. Method: This multicenter single-blind, cohort study was conducted at two distinct university hospitals between May 2023 and September 2024. Patients who underwent intra-articular knee ozone injection were examined and divided into two groups as 15 μg/ml (Group A) and 25 μg/ml ozone (Group B). Participants' pain scores were measured by Numeric Rating Scale (NRS), functional status by Western Ontario and McMaster Universities Arthritis Index (WOMAC) and quality of life by Short Form-12 (SF-12) before and at 1 and 3 months following ozone therapy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

159

Interventions

ozone injectionOTHER

Ozone (O2-O3) therapy is widely used in clinical practice as an alternative medical approach in the treatment of musculoskeletal diseases. Many recent studies have reported that intra-articular ozone implementation has a positive impact on knee osteoarthritis. Most available studies have focused on the comparison of ozone therapy with other intra-articular injections. However, the influence of the concentration and/or volume of the ozone used during injection on treatment outcomes has been omitted. The concentration of ozone administered into the joint varies, typically ranging from 15 to 30 μg/ml in these studies; however, there is no consensus regarding the appropriate dosage to be used. Based on this gap in the literature, we aimed to compare pain, functional status and quality of life among patients treated with different concentrations of intra-articular ozone therapy.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 50-85 years with a diagnosis of primary knee osteoarthritis according to the American College of Rheumatology \[12\] criteria, symptomatic knee with KL \[13\] grades II, III and IV, who underwent intra-articular ozone treatment. Exclusion Criteria: * Patients with a history of any intra-articular injection within 3 months before the first ozone injection, a history of previous knee surgery, a diagnosis of malignancy, missing follow-up parameters, bilateral intra-articular knee ozone injection, a secondary knee osteoarthritis diagnosis (trauma, inflammatory joint disease, etc.), patients without demographic and clinical data, or direct radiographs.

Outcomes

Primary Outcomes

Numeric rating scale (NRS)

The NRS is a widely utilised tool for assessing and tracking pain severity. The rating scale consists of 11 points, where 0 signifies the absence of pain and 10 denotes the most excruciating pain imaginable. The patient is instructed to assess their pain on this scale from 0 to 10.

Time frame: prior to the procedure and at 1 and 3 months post-procedure.

Secondary Outcomes

Western Ontario and McMaster Universities Arthritis Index (WOMAC)

This questionnaire was developed to assess joint function associated with osteoarthritis and consists of three main sections: pain, stiffness, and physical function.