Evaluation of the Effect of Different Doses of Ozone Therapy on Pain and Function of Patients With Knee Osteoarthritis

NCT06088706 | Completed DMC

• 1 other identifier: ir.iums.fmd.rec.1401.412
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a randomized clinical trial that will be conducted in Hazrat Rasool Akram Hospital in Tehran. Patients with knee osteoarthritis were selected based on the study entry criteria and written consent was obtained from them. Then, by random assignment, patients will be divided into three treatment groups: control group (under oxygen gas injection), intervention group 1 (intra-articular injection of ozone with a dose of 20 micrograms) and intervention group 2 (intra-articular injection of ozone with a dose of 40 micrograms).

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• Questionnaire evaluations womac

  Western Ontario and McMaster Universities Osteoarthritis Index questionnaire or WOMAC for short: This questionnaire has 24 items which are arranged in three sections. 1. The first part examines pain with five items in different positions of walking, climbing stairs, while resting in bed, while sitting or sleeping, and standing. 2. The second part examines morning dryness and joint stiffness at the end of the day with two items. 3. The third section examines the patient's functional activities in different situations with seventeen items. It is worth mentioning that the translation, localization and validation of WOMAC questionnaire in Iran was done in 2014 by Dr. Ebrahimzadeh and his colleagues.

  before the intervention and two weeks later, one month and three months after the intervention

• Visual Analogue Scale

  Feeling pain in the knee with vas criteria

  before the intervention and two weeks later, one month and three months after the intervention

Secondary Outcomes (3)

• range of motion

  before the intervention and two weeks later, one month and three months after the intervention

• Timed Up & Go functional test

  before the intervention and two weeks later, one month and three months after the intervention

• Six-Minute Walk Functional Test

  before the intervention and two weeks later, one month and three months after the intervention

Study Arms (3)

Intervention group 1 (O3 20mg)

EXPERIMENTAL

the patient is lying on the bed with his knee flexed at about 45 degrees. Then The syringe containing ozone is prepared by a sports medicine assistant and covered with a label so that the clinician is not aware of the injected ozone dose. Lateral Approach will be used for intra-articular injection. after preparation and drape of the desired position and aspiration, the ozone composition will be injected into the joint. In order to inject for this group, a 10 cc needle and a predetermined concentration of 20 micrograms is injected under sterile conditions. The duration of the injection will be 15-20 seconds. The number of sessions considered for injection will be three sessions, once a week for three weeks. The second and third injection will be done under the same conditions as the first session. In this study, Ozonette Sedecal device ( Spain) will be used. And the exercise therapy protocol is performed.

Procedure: Intra-articular injection of ozone

Intervention group 2 (O3 40mg)

ACTIVE COMPARATOR

Just like intervention group 1, in this group, a predetermined concentration of 40 micrograms ozone is injected under sterile conditions.According to the standard treatment guidelines of the American College of Rheumatology, 1gram of acetaminophen in two doses of 500 mg is allowed up to two weeks after daily injections, which is applicable to all three groups.

Procedure: Intra-articular injection of ozone

Control group

PLACEBO COMPARATOR

Just like intervention group 1, in this group, a syringe containing oxygen without ozone is injected under sterile conditions.

Procedure: Intra-articular injection of ozone

Interventions

Intra-articular injection of ozone PROCEDURE

the patient is lying on the bed with his knee flexed at about 45 degrees. Then The syringe containing ozone is prepared by a sports medicine assistant and covered with a label so that the clinician is not aware of the injected ozone dose. Lateral Approach will be used for intra-articular injection. after preparation and drape of the desired position and aspiration, the ozone composition will be injected into the joint. In order to inject for this group, a 10 cc needle and a predetermined concentration of 20 and 40 micrograms ozone are used under sterile conditions. The duration of the injection will be 15-20 seconds. The number of sessions considered for injection will be three sessions, once a week for three weeks. The second and third injection will be done under the same conditions as the first session. In this study, Ozonette Sedecal device ( Spain) will be used. And the exercise therapy protocol is performed.

Control group; Intervention group 1 (O3 20mg); Intervention group 2 (O3 40mg)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having primary knee osteoarthritis grade 2 and 3 according to the doctor's diagnosis and based on the Kellgren and Lawrence criteria (the presence of knee pain, morning dryness for less than 30 minutes, crypts during movement and radiological signs of osteoarthritis including joint space reduction, subchondral bone sclerosis and osteophyte formation in knee)
• Age 50-75 years
• Suffering from continuous knee pain for at least six months and with a severity of at least 4 based on the VAS criteria in physical activities such as going up and down the stairs, sitting for a long time and squatting
• Ability to walk independently for at least 30 meters
• Body mass index equal to or less than 35
• Complete consent of the patient to participate in the research
• Balanced mental state

You may not qualify if:

• History of intra-articular injections in the knee during the last six months
• Suffering from neuromuscular diseases
• Presence of acute traumatic injury in other ligaments and structures of the knee joint as confirmed by a specialist doctor
• History of previous surgery or injury in the knee and other joints of the lower limbs during the last year
• Presence of bone implants
• The presence of new fractures in the lower limbs during the last year
• Getting malignant tumors
• Participation in sports therapy and physiotherapy programs during the last three months

Sponsors & Collaborators

• Ahmad Nazari: lead

Study Sites (1)

Department of Sports and Exercise Medicine, School of Medicine, Iran University of Medical Sciences

Tehran, 14496-14535, Iran

Location

Related Publications (1)

• Arjmanddoust Z, Nazari A, Moezy A. Efficacy of two doses of intra-articular ozone therapy for pain and functional mobility in knee osteoarthritis: a double-blind randomized trial. Adv Rheumatol. 2025 Mar 6;65(1):11. doi: 10.1186/s42358-025-00443-w.

  PMID: 40050950 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinician: injection interventions are performed under the supervision of a sports medicine specialist who does not know the dose of the injections and only injects the solution prepared by another assistant. Assessor Clinician: Assessments before and after interventions will be done by a sports medicine resident who is not involved in running the trial. Statistical analyzer: The analysis of the research data will be done by a statistical consultant who is not aware of the patient groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: In the randomized clinical trial study, Convenience Sampling will be done among the patients with knee osteoarthritis called to the sports medicine assessment clinic, at Hazrat Rasool Akram hospital. Allocation of patients in treatment groups will be done randomly using blocks with blocks of six in one of the treatment groups as follows: A: Control (CL) B: O3 20mg C: O3 40mg The block randomization method is used to assign people to the three study groups. For this purpose, the length of the block will be equal to 6 houses (two houses for each treatment).

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 18, 2023
• Study Start: November 20, 2023
• Primary Completion: April 10, 2024
• Study Completion: May 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

IR (1)