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

NCT06328270 | Completed

• 1 other identifier: 03.09.2019 / 2505
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Visual Pain Score

  Pain status of the patients was questioned with a scale between 0-10

  4 weeks after the first dose of treatment

• Western Ontario and McMaster Universities Arthritis Index

  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:\[1\] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties

  4 weeks after the first dose of treatment

Secondary Outcomes (2)

• Visual Pain Score

  12 weeks after the first dose of treatment

• Western Ontario and McMaster Universities Arthritis Index

  12 weeks after the first dose of treatment

Study Arms (2)

Study Group

ACTIVE COMPARATOR

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

Other: Ozone - oxygen Therapy

Control Group

ACTIVE COMPARATOR

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

Other: Corticosteroid

Interventions

Ozone - oxygen Therapy OTHER

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

Study Group

Corticosteroid OTHER

1 ml betamethasone

Control Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: September 1, 2020
• Primary Completion: January 30, 2022
• Study Completion: March 30, 2022
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)