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

NCT04830423 | Unknown

• 1 other identifier: 13
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Keywords

ozone injection; steroid injection; ultrasound; knee pain

Outcome Measures

Primary Outcomes (1)

• PAIN - Numerical Rating Scale (NRS)

  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 Outcomes (2)

• Quality of life - Short Form-36 (SF-36)

  initial, 4th week 12th week pain change

• PAIN, PHYSICAL FUNCTION -Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  initial, 4th week 12th week pain change

Study Arms (2)

medikal ozone group

ACTIVE COMPARATOR

medical ozone group patients diagnosed with knee ostheoarthritis

Procedure: Medical ozone injection

steroid group

OTHER

steroid group patients diagnosed with knee ostheoarthritis

Procedure: steroid injection group

Interventions

Medical ozone injection PROCEDURE

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.

medikal ozone group

steroid injection group PROCEDURE

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.

steroid group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female / male aged\> 45 years
• Diagnosis of knee ostheoarthritis after physical examination and imaging (direct radiography)
• Those whose symptoms persist\> 6 months
• Radiological staging of osteoarthritis according to the Kellgren-Lawrence scale Grade 2 and 3
• Participation in the study voluntarily and regularly

You may not qualify if:

• History of previous knee surgery
• Patients with inflammatory arthritis (Rheumatoid arthritis, psoriatic arthritis, gouty arthritis as)
• Patients with neuropathic pain
• Those with pain reflected from the waist or hip
• History of tumor, infectious, psychiatric illness, bleeding diathesis
• Trauma history within the last 6 months
• Hyaluronic acid or steroid injection in the last 3 months
• Those with systemic diseases such as diabetes, rheumatoid arthritis, hepatitis, coagulopathy
• Those with malignant hypertension
• Those with G6PDH (Glucose 6-Phosphate Dehydrogenase) deficiency
• Those with Graves' disease
• Those with cerebrovascular event disease in which bleeding continues actively

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Sefa

Ankara, 06660, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Sefa Gümrük Aslan

  Gaziler Physical Medicine And Rehabilitation Health Application And Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sefa Gümrük Aslan

CONTACT

05319831406; sefagumrukk@gmail.com

Sefa g Gümrük Aslan

CONTACT

05319831406; sefagumrukk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: April 15, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: March 16, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)