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Ozone shots for thumb arthritis: a new hope?

NCT ID NCT07171840

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

43 people

The number who actually took part.

Started

May 2021

Finished

Dec 2022

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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