Ozone shots for thumb arthritis: a new hope?
NCT ID NCT07171840
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether injecting oxygen-ozone into the thumb joint, along with wearing a splint, reduces pain and improves hand function in people with thumb osteoarthritis. 43 adults took part. The goal was to see if this combination works better than using a splint alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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43 people
The number who actually took part.
- Started
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May 2021
- Finished
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Dec 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Exclusion Criteria: 1. Presence of clinically observed active infection or severe inflammation in the index trapezio-metacarpal joint or skin disease/breakdown or infection in the area of the planned injection site of the index thumb joint. 2. Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; Human Immunodeficiency Virus (HIV), viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis. 3. Diagnosed with leukaemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment. 4. Disease of cervical spine, shoulder or other upper extremity joints judged by the investigator to be contributing to the pain in the index thumb joint (e.g. radiculopathy, De Quervain S., etc.). 5. Untreated symptomatic injury of the index hand (e.g., acute traumatic injury, tendinopathy, nerve lesion). 6. Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the index thumb joint. 7. Presence of venous or lymphatic stasis in the index arm. 8. Orally administered systemic steroid use within 2 weeks prior to screening 9. Planned/anticipated surgery of the index hand during the study period. 10. Major surgery of the index hand within 12 months prior to screening. 11. Minor surgery (e.g. arthroscopy) of the index hand within 6 months prior to screening 12. Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening, which, in the opinion of the investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection. 13. Pregnant or nursing mothers or women planning to become pregnant during the time they will be participating in the study. 14. Previously documented failed treatment with OOT or splint 15. Known drug or alcohol dependence currently or within the last year. 16. Use of any investigational drug or device within 30 days prior to screening. 17. Use of any investigational biologics within 60 days prior to screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Humanitas Research Hospital
Rozzano, Milano, 20089, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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