Clinical trial NCT04830423: The Effectiveness of Ultrasound Guided Ozone (O2-O3) Injection With Knee Osteoarthritis
Official title: The Effectiveness of Ultrasound Guided Intraarticular and Periarticular Ozone (O2-O3) Injection in the Treatment of Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: ozone injection
steroid injection
ultrasound
knee pain
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 96
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PAIN - Numerical Rating Scale (NRS)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Quality of life - Short Form-36 (SF-36)
timeFrame: initial, 4th week 12th week pain change
measure: PAIN, PHYSICAL FUNCTION -Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: initial, 4th week 12th week pain change
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sefa
Study officials:
affiliation: Gaziler Physical Medicine And Rehabilitation Health Application And Research Center
name: Sefa Gümrük Aslan
role: PRINCIPAL_INVESTIGATOR
References: