Osteo Arthritis KneeNCT06088706
Evaluation of the Effect of Different Doses of Ozone Therapy on Pain and Function of Patients With Knee Osteoarthritis
A study testing Intra-articular injection of ozone in people with Osteo Arthritis Knee, run by Ahmad Nazari at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Intra-articular injection of ozone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 20 Nov 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Sports and Exercise Medicine, School of Medicine, Iran University of Medical Sciences
Tehran, 14496-14535
About this study
Official title: Evaluation of the Effect of Different Doses of Ozone Therapy on Pain and Function of Patients With Knee Osteoarthritis Referred to the Sports Medicine Clinic of Hazrat Rasool Akram Hospital
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).
Read the detailed description
This research is a type of randomized clinical trial (RCT) in which the studied samples will be selected from the patients with knee osteoarthritis referring to Hazrat Rasool Akram hospital by available sampling method. All the stages of this research will be done with the approval of the ethics committee of the Research Vice-Chancellor of Iran University of Medical Sciences, and written consent will be obtained from all the participants in this research.
The population studied in this research will be made up of knee osteoarthritis sufferers who, according to the announcements that will be posted at the hospitals of Iran University of Medical Sciences in Tehran, will come from all urban areas to participate in this study to Hazrat Rasool Akram Hospital.) will be called and after meeting the conditions for entering the research, they will be randomly placed in one of the proposed treatment groups.
The intervention groups in this research are:
- Control group - intra-articular injection of oxygen without ozone
- Intervention group 1- Intra-articular injection of ozone with a dose of 20 micrograms
- Intervention group 2- Intra-articular injection of ozone with a dose of 40 micrograms In the next step, a summary of the evaluation and treatment plans for the participants will be stated in simple language, and after that, the results of the research on the studied patients will be evaluated and the results will be recorded. Then, according to their groups, the patients will be subjected to exercise therapy interventions under supervision in the clinic or based on the Internet for six weeks. Before and in the second week, the first month and the third month after the intervention, patients will be evaluated with VAS, knee range of motion, WOMAC questionnaires and functional tests (6MWT and Timed Up and Go Test).
- Conditions
- Osteo Arthritis Knee
- Being tested
- Intra-articular injection of ozone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injection of ozoneProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Intra-articular injection of ozone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
- The second part examines morning dryness and joint stiffness at the end of the day with two items.
- 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.
Measured: 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
Measured: before the intervention and two weeks later, one month and three months after the intervention
Secondary outcomes (3)
range of motion
In this research, the active range of motion of the knee is measured with a goniometer and recorded in degrees
Measured: before the intervention and two weeks later, one month and three months after the intervention
Timed Up & Go functional test
n this evaluation, the patient will be asked to get up from a standard chair and walk along a line drawn on the floor in front of a three-meter long chair in a completely comfortable and safe manner, then go around and walk again. Return to the side of the chair and sit on it. The time to perform this test will be measured with a stopwatch and recorded in seconds.
Measured: before the intervention and two weeks later, one month and three months after the intervention
Six-Minute Walk Functional Test
In this evaluation, the patient will be asked to walk the maximum distance he can within 6 minutes. The distance traveled by the patient during the test will be measured with a tape measure and recorded with a meter unit.
Each of these functional evaluations is repeated three times and the best result for the patient will be recorded
Measured: before the intervention and two weeks later, one month and three months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start20 Nov 2023
- Primary completion10 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Nazari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad Nazari, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088706
- Sponsor's protocol ID
- ir.iums.fmd.rec.1401.412
- Status last verified
- Jul 2024
- First submitted
- 28 Sep 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40050950
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Doses of Ozone Therapy on Pain and Function of Patients With Knee Osteoarthritis Referred to the Sports Medicine Clinic of Hazrat Rasool Akram Hospital
- ClinicalTrials.gov ID
- NCT06088706
- Acronym / sponsor ID
- ir.iums.fmd.rec.1401.412
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ahmad NazariUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This research is a type of randomized clinical trial (RCT) in which the studied samples will be selected from the patients with knee osteoarthritis referring to Hazrat Rasool Akram hospital by available sampling method. All the stages of this research will be done with the approval of the ethics committee of the Research Vice-Chancellor of Iran University of Medical Sciences, and written consent will be obtained from all the participants in this research.
The population studied in this research will be made up of knee osteoarthritis sufferers who, according to the announcements that will be posted at the hospitals of Iran University of Medical Sciences in Tehran, will come from all urban areas to participate in this study to Hazrat Rasool Akram Hospital.) will be called and after meeting the conditions for entering the research, they will be randomly placed in one of the proposed treatment groups.
The intervention groups in this research are:
- Control group - intra-articular injection of oxygen without ozone
- Intervention group 1- Intra-articular injection of ozone with a dose of 20 micrograms
- Intervention group 2- Intra-articular injection of ozone with a dose of 40 micrograms In the next step, a summary of the evaluation and treatment plans for the participants will be stated in simple language, and after that, the results of the research on the studied patients will be evaluated and the results will be recorded. Then, according to their groups, the patients will be subjected to exercise therapy interventions under supervision in the clinic or based on the Internet for six weeks. Before and in the second week, the first month and the third month after the intervention, patients will be evaluated with VAS, knee range of motion, WOMAC questionnaires and functional tests (6MWT and Timed Up and Go Test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 (O3 20mg) | Experimental | Procedure: Intra-articular injection of ozonethe 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. |
| Intervention group 2 (O3 40mg) | Active comparator | Procedure: Intra-articular injection of ozoneJust 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. |
| Control group | Placebo comparator | Procedure: Intra-articular injection of ozoneJust like intervention group 1, in this group, a syringe containing oxygen without ozone is injected under sterile conditions. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular injection of ozonethe 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. | Procedure or surgery | Control group, Intervention group 1 (O3 20mg), Intervention group 2 (O3 40mg) |
Primary outcome
Questionnaire evaluations womac
Time frame: before the intervention and two weeks later, one month and three months after the intervention
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.
Visual Analogue Scale
Time frame: before the intervention and two weeks later, one month and three months after the intervention
Feeling pain in the knee with vas criteria
3 secondary outcomes
range of motion
Time frame: before the intervention and two weeks later, one month and three months after the intervention
Timed Up & Go functional test
Time frame: before the intervention and two weeks later, one month and three months after the intervention
Six-Minute Walk Functional Test
Time frame: before the intervention and two weeks later, one month and three months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Derived from this study: PubMed 40050950Arjmanddoust 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular injection of ozone in people with Osteo Arthritis Knee, run by Ahmad Nazari at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire evaluations womac (time frame: before the intervention and two weeks later, one month and three months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06088706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.