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

Knee Osteoarthritis Clinical Trial

Official title:

The Effectiveness of Ultrasound Guided Intraarticular and Periarticular Ozone (O2-O3) Injection in the Treatment of Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830423
• Other study ID #: 13
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: April 2021
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Sefa Gümrük Aslan
• Phone: 05319831406
• Email: sefagumrukk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Medical ozone injection
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.
• steroid injection group
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.

Locations

Country	Name	City	State
Turkey	Sefa	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life - Short Form-36 (SF-36)	Satisfaction assessed by the SF-36. Short Form (SF-36) was used to investigate the quality of life of the patients.The reliability and validity of the Turkishversion of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores show better Quality of life.	initial, 4th week 12th week pain change
Secondary	PAIN, PHYSICAL FUNCTION -Western Ontario and McMaster Universities Arthritis Index (WOMAC)	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:Pain, Stiffness and Physical Function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.	initial, 4th week 12th week pain change