Knee OsteoarthristisNCT07662512
Different Ozone Concentrations for Knee Osteoarthritis
A study testing ozone injection in people with Knee Osteoarthristis and Gonarthrosis, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Knee osteoarthritis is a common condition that causes pain, stiffness, and difficulty with daily activities. Ozone injection therapy is a minimally invasive treatment that has been increasingly used to relieve symptoms in people with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthristis, Gonarthrosis
- What is being tested?
- ozone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 3 Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 50-85 years with a diagnosis of primary knee osteoarthritis according to the American College of Rheumatology [12] criteria, symptomatic knee with KL [13] grades II, III and IV, who underwent intra-articular ozone treatment.
Who cannot join
- Patients with a history of any intra-articular injection within 3 months before the first ozone injection, a history of previous knee surgery, a diagnosis of malignancy, missing follow-up parameters, bilateral intra-articular knee ozone injection, a secondary knee osteoarthritis diagnosis (trauma, inflammatory joint disease, etc.), patients without demographic and clinical data, or direct radiographs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Intra-articular Injection of High-concentration Ozone (O2-O3) More Effective in Treating Knee Osteoarthritis?: A Multicenter Clinical Trial
Knee osteoarthritis is a common condition that causes pain, stiffness, and difficulty with daily activities. Ozone injection therapy is a minimally invasive treatment that has been increasingly used to relieve symptoms in people with knee osteoarthritis. However, it is not clear whether different ozone concentrations produce different treatment outcomes.
In this study, we compared the effects of two commonly used ozone concentrations (15 μg/mL and 25 μg/mL) in patients with knee osteoarthritis. A total of 159 patients received intra-articular ozone injections and were followed for 3 months. Pain, physical function, and quality of life were assessed before treatment and at 1 and 3 months after the injections.
Read the detailed description
Background: Knee osteoarthritis (KOA) is a prevalent joint disorder globally, resulting in pain and disability, with various treatment options available. Intra-articular ozone (O2-O3) administrations are an efficient therapeutic approach commonly employed in this condition. With this study, we aimed to compare the effect of varying ozone concentrations on treatment outcomes.
Method: This multicenter single-blind, cohort study was conducted at two distinct university hospitals between May 2023 and September 2024. Patients who underwent intra-articular knee ozone injection were examined and divided into two groups as 15 μg/ml (Group A) and 25 μg/ml ozone (Group B). Participants' pain scores were measured by Numeric Rating Scale (NRS), functional status by Western Ontario and McMaster Universities Arthritis Index (WOMAC) and quality of life by Short Form-12 (SF-12) before and at 1 and 3 months following ozone therapy.
- Conditions
- Knee Osteoarthristis, Gonarthrosis
- Being tested
- ozone injection
- Keywords
- knee osteoarthritis, intra-articular injection, ozone therapy, ozone concentration
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozone injectionOther
Ozone (O2-O3) therapy is widely used in clinical practice as an alternative medical approach in the treatment of musculoskeletal diseases. Many recent studies have reported that intra-articular ozone implementation has a positive impact on knee osteoarthritis. Most available studies have focused on the comparison of ozone therapy with other intra-articular injections. However, the influence of the concentration and/or volume of the ozone used during injection on treatment outcomes has been omitted. The concentration of ozone administered into the joint varies, typically ranging from 15 to 30 μg/ml in these studies; however, there is no consensus regarding the appropriate dosage to be used. Based on this gap in the literature, we aimed to compare pain, functional status and quality of life among patients treated with different concentrations of intra-articular ozone therapy.
| Study group | Role | What they receive |
|---|---|---|
| 15 μg/ml-10 ml ozone (Group A) | Active comparator | Not described Receives: Other: ozone injection |
| 25 μg/ml-10 ml ozone (Group B) | Active comparator | Not described Receives: Other: ozone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
The NRS is a widely utilised tool for assessing and tracking pain severity. The rating scale consists of 11 points, where 0 signifies the absence of pain and 10 denotes the most excruciating pain imaginable. The patient is instructed to assess their pain on this scale from 0 to 10.
Measured: prior to the procedure and at 1 and 3 months post-procedure.
Secondary outcomes (1)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
This questionnaire was developed to assess joint function associated with osteoarthritis and consists of three main sections: pain, stiffness, and physical function.
Measured: prior to the procedure and at 1 and 3 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start2 May 2023
- Primary completion2 May 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthristisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients who underwent intra-articular knee ozone injection were examined and divided into two groups as 15 μg/ml (Group A) and 25 μg/ml ozone (Group B).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alİ Eman, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662512
- Sponsor's protocol ID
- E-71522473-050.04-372963-174
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The underlying datasets related to the results of the research paper can be shared as needed. If someone would like to request the data from this study, they can contact the corresponding author, Ridvan Isik, MD.
Publications
Sconza C, Respizzi S, Virelli L, Vandenbulcke F, Iacono F, Kon E, Di Matteo B. Oxygen-Ozone Therapy for the Treatment of Knee Osteoarthritis: A Systematic Review of Randomized Controlled Trials. Arthroscopy. 2020 Jan;36(1):277-286. doi: 10.1016/j.arthro.2019.05.043. Epub 2019 Oct 31.
PubMed 31679646Jeyaraman M, Jeyaraman N, Ramasubramanian S, Balaji S, Nallakumarasamy A, Patro BP, Migliorini F. Ozone therapy in musculoskeletal medicine: a comprehensive review. Eur J Med Res. 2024 Jul 31;29(1):398. doi: 10.1186/s40001-024-01976-4.
PubMed 39085932Oliviero A, Giordano L, Maffulli N. The temporal effect of intra-articular ozone injections on pain in knee osteoarthritis. Br Med Bull. 2019 Dec 11;132(1):33-44. doi: 10.1093/bmb/ldz028.
PubMed 31602459Yan H, Guo J, Zhou W, Dong C, Liu J. Health-related quality of life in osteoarthritis patients: a systematic review and meta-analysis. Psychol Health Med. 2022 Sep;27(8):1859-1874. doi: 10.1080/13548506.2021.1971725. Epub 2021 Aug 31.
PubMed 34465255Farr Ii J, Miller LE, Block JE. Quality of life in patients with knee osteoarthritis: a commentary on nonsurgical and surgical treatments. Open Orthop J. 2013 Nov 13;7:619-23. doi: 10.2174/1874325001307010619. eCollection 2013.
PubMed 24285987Rahimzadeh P, Imani F, Azad Ehyaei D, Faiz SHR. Efficacy of Oxygen-Ozone Therapy and Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Meta-analysis and Systematic Review. Anesth Pain Med. 2022 Oct 1;12(4):e127121. doi: 10.5812/aapm-127121. eCollection 2022 Aug.
PubMed 36937082Pasek J, Szajkowski S, Rokicka D, Wrobel M, Travagli V, Cieslar G. Impact of ozone concentration on the treatment effectiveness of diabetic foot syndrome: a pilot single-centre study. Postepy Dermatol Alergol. 2024 Dec;41(6):626-633. doi: 10.5114/ada.2024.145477. Epub 2024 Dec 24.
PubMed 39877112Chen H, Yu B, Lu C, Lin Q. The effect of intra-articular injection of different concentrations of ozone on the level of TNF-alpha, TNF-R1, and TNF-R2 in rats with rheumatoid arthritis. Rheumatol Int. 2013 May;33(5):1223-7. doi: 10.1007/s00296-012-2529-7. Epub 2012 Oct 2.
PubMed 23052485Lino VTS, Marinho DS, Rodrigues NCP, Andrade CAF. Efficacy and safety of ozone therapy for knee osteoarthritis: an umbrella review of systematic reviews. Front Physiol. 2024 Feb 20;15:1348028. doi: 10.3389/fphys.2024.1348028. eCollection 2024.
PubMed 38444768de Sire A, Agostini F, Lippi L, Mangone M, Marchese S, Cisari C, Bernetti A, Invernizzi M. Oxygen-Ozone Therapy in the Rehabilitation Field: State of the Art on Mechanisms of Action, Safety and Effectiveness in Patients with Musculoskeletal Disorders. Biomolecules. 2021 Feb 26;11(3):356. doi: 10.3390/biom11030356.
PubMed 33652804Arias-Vazquez PI, Tovilla-Zarate CA, Hernandez-Diaz Y, Gonzalez-Castro TB, Juarez-Rojop IE, Lopez-Narvaez ML, Bermudez-Ocana DY, Barjau-Madrigal HA, Legorreta-Ramirez G. Short-Term Therapeutic Effects of Ozone in the Management of Pain in Knee Osteoarthritis: A Meta-Analysis. PM R. 2019 Aug;11(8):879-887. doi: 10.1002/pmrj.12088. Epub 2019 May 30.
PubMed 30689297Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Soysal Gunduz O, Mutlu S, Aslan Basli A, Gul C, Akgul O, Yilmaz E, Aydemir O. Validation of the Turkish Form of Short Form-12 health survey version 2 (SF-12v2). Arch Rheumatol. 2021 Jan 14;36(2):280-286. doi: 10.46497/ArchRheumatol.2021.8458. eCollection 2021 Jun.
PubMed 34527934Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.
PubMed 15639634KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
PubMed 13498604
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Intra-articular Injection of High-concentration Ozone (O2-O3) More Effective in Treating Knee Osteoarthritis?: A Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07662512
- Acronym / sponsor ID
- E-71522473-050.04-372963-174
- Conditions
- Knee Osteoarthristis, Gonarthrosis
- Keywords
- knee osteoarthritis, intra-articular injection, ozone therapy, ozone concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 23 Jun 2026 (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.
Knee osteoarthritis is a common condition that causes pain, stiffness, and difficulty with daily activities. Ozone injection therapy is a minimally invasive treatment that has been increasingly used to relieve symptoms in people with knee osteoarthritis. However, it is not clear whether different ozone concentrations produce different treatment outcomes.
In this study, we compared the effects of two commonly used ozone concentrations (15 μg/mL and 25 μg/mL) in patients with knee osteoarthritis. A total of 159 patients received intra-articular ozone injections and were followed for 3 months. Pain, physical function, and quality of life were assessed before treatment and at 1 and 3 months after the injections.
Detailed description
Background: Knee osteoarthritis (KOA) is a prevalent joint disorder globally, resulting in pain and disability, with various treatment options available. Intra-articular ozone (O2-O3) administrations are an efficient therapeutic approach commonly employed in this condition. With this study, we aimed to compare the effect of varying ozone concentrations on treatment outcomes.
Method: This multicenter single-blind, cohort study was conducted at two distinct university hospitals between May 2023 and September 2024. Patients who underwent intra-articular knee ozone injection were examined and divided into two groups as 15 μg/ml (Group A) and 25 μg/ml ozone (Group B). Participants' pain scores were measured by Numeric Rating Scale (NRS), functional status by Western Ontario and McMaster Universities Arthritis Index (WOMAC) and quality of life by Short Form-12 (SF-12) before and at 1 and 3 months following ozone therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who underwent intra-articular knee ozone injection were examined and divided into two groups as 15 μg/ml (Group A) and 25 μg/ml ozone (Group B).
| Arm | Type | Receives |
|---|---|---|
| 15 μg/ml-10 ml ozone (Group A) | Active comparator | Other: ozone injection |
| 25 μg/ml-10 ml ozone (Group B) | Active comparator | Other: ozone injection |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 50-85 years with a diagnosis of primary knee osteoarthritis according to the American College of Rheumatology [12] criteria, symptomatic knee with KL [13] grades II, III and IV, who underwent intra-articular ozone treatment.
Key exclusion criteria (1 listed)
- Patients with a history of any intra-articular injection within 3 months before the first ozone injection, a history of previous knee surgery, a diagnosis of malignancy, missing follow-up parameters, bilateral intra-articular knee ozone injection, a secondary knee osteoarthritis diagnosis (trauma, inflammatory joint disease, etc.), patients without demographic and clinical data, or direct radiographs.
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 |
|---|---|---|
| ozone injectionOzone (O2-O3) therapy is widely used in clinical practice as an alternative medical approach in the treatment of musculoskeletal diseases. Many recent studies have reported that intra-articular ozone implementation has a positive impact on knee osteoarthritis. Most available studies have focused on the comparison of ozone therapy with other intra-articular injections. However, the influence of the concentration and/or volume of the ozone used during injection on treatment outcomes has been omitted. The concentration of ozone administered into the joint varies, typically ranging from 15 to 30 μg/ml in these studies; however, there is no consensus regarding the appropriate dosage to be used. Based on this gap in the literature, we aimed to compare pain, functional status and quality of life among patients treated with different concentrations of intra-articular ozone therapy. | Other | 15 μg/ml-10 ml ozone (Group A), 25 μg/ml-10 ml ozone (Group B) |
Primary outcome
Numeric rating scale (NRS)
Time frame: prior to the procedure and at 1 and 3 months post-procedure.
The NRS is a widely utilised tool for assessing and tracking pain severity. The rating scale consists of 11 points, where 0 signifies the absence of pain and 10 denotes the most excruciating pain imaginable. The patient is instructed to assess their pain on this scale from 0 to 10.
1 secondary outcome
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: prior to the procedure and at 1 and 3 months post-procedure.
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 23 Jun 2026.
- Background: PubMed 31679646Sconza C, Respizzi S, Virelli L, Vandenbulcke F, Iacono F, Kon E, Di Matteo B. Oxygen-Ozone Therapy for the Treatment of Knee Osteoarthritis: A Systematic Review of Randomized Controlled Trials. Arthroscopy. 2020 Jan;36(1):277-286. doi: 10.1016/j.arthro.2019.05.043. Epub 2019 Oct 31.
- Background: PubMed 39085932Jeyaraman M, Jeyaraman N, Ramasubramanian S, Balaji S, Nallakumarasamy A, Patro BP, Migliorini F. Ozone therapy in musculoskeletal medicine: a comprehensive review. Eur J Med Res. 2024 Jul 31;29(1):398. doi: 10.1186/s40001-024-01976-4.
- Background: PubMed 31602459Oliviero A, Giordano L, Maffulli N. The temporal effect of intra-articular ozone injections on pain in knee osteoarthritis. Br Med Bull. 2019 Dec 11;132(1):33-44. doi: 10.1093/bmb/ldz028.
- Background: PubMed 34465255Yan H, Guo J, Zhou W, Dong C, Liu J. Health-related quality of life in osteoarthritis patients: a systematic review and meta-analysis. Psychol Health Med. 2022 Sep;27(8):1859-1874. doi: 10.1080/13548506.2021.1971725. Epub 2021 Aug 31.
- Background: PubMed 24285987Farr Ii J, Miller LE, Block JE. Quality of life in patients with knee osteoarthritis: a commentary on nonsurgical and surgical treatments. Open Orthop J. 2013 Nov 13;7:619-23. doi: 10.2174/1874325001307010619. eCollection 2013.
- Background: PubMed 36937082Rahimzadeh P, Imani F, Azad Ehyaei D, Faiz SHR. Efficacy of Oxygen-Ozone Therapy and Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Meta-analysis and Systematic Review. Anesth Pain Med. 2022 Oct 1;12(4):e127121. doi: 10.5812/aapm-127121. eCollection 2022 Aug.
- Background: PubMed 39877112Pasek J, Szajkowski S, Rokicka D, Wrobel M, Travagli V, Cieslar G. Impact of ozone concentration on the treatment effectiveness of diabetic foot syndrome: a pilot single-centre study. Postepy Dermatol Alergol. 2024 Dec;41(6):626-633. doi: 10.5114/ada.2024.145477. Epub 2024 Dec 24.
- Background: PubMed 23052485Chen H, Yu B, Lu C, Lin Q. The effect of intra-articular injection of different concentrations of ozone on the level of TNF-alpha, TNF-R1, and TNF-R2 in rats with rheumatoid arthritis. Rheumatol Int. 2013 May;33(5):1223-7. doi: 10.1007/s00296-012-2529-7. Epub 2012 Oct 2.
- Background: PubMed 38444768Lino VTS, Marinho DS, Rodrigues NCP, Andrade CAF. Efficacy and safety of ozone therapy for knee osteoarthritis: an umbrella review of systematic reviews. Front Physiol. 2024 Feb 20;15:1348028. doi: 10.3389/fphys.2024.1348028. eCollection 2024.
- Background: PubMed 33652804de Sire A, Agostini F, Lippi L, Mangone M, Marchese S, Cisari C, Bernetti A, Invernizzi M. Oxygen-Ozone Therapy in the Rehabilitation Field: State of the Art on Mechanisms of Action, Safety and Effectiveness in Patients with Musculoskeletal Disorders. Biomolecules. 2021 Feb 26;11(3):356. doi: 10.3390/biom11030356.
- Background: PubMed 30689297Arias-Vazquez PI, Tovilla-Zarate CA, Hernandez-Diaz Y, Gonzalez-Castro TB, Juarez-Rojop IE, Lopez-Narvaez ML, Bermudez-Ocana DY, Barjau-Madrigal HA, Legorreta-Ramirez G. Short-Term Therapeutic Effects of Ozone in the Management of Pain in Knee Osteoarthritis: A Meta-Analysis. PM R. 2019 Aug;11(8):879-887. doi: 10.1002/pmrj.12088. Epub 2019 May 30.
- Background: PubMed 6226917Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
- Individual participant dataSharing planned: Undecided. The underlying datasets related to the results of the research paper can be shared as needed. If someone would like to request the data from this study, they can contact the corresponding author, Ridvan Isik, MD.
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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 ozone injection in people with Knee Osteoarthristis and Gonarthrosis, run by Sakarya University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 23 Jun 2026. 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 Turkey (Türkiye). 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. 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?
Numeric rating scale (NRS) (time frame: prior to the procedure and at 1 and 3 months post-procedure.). 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 NCT07662512, which also lists 27 linked publications.
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 23 Jun 2026.