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NCT07171840
Effectiveness of Intra-articular Oxygen-ozone Injections and Splinting for the Treatment of Thumb Osteoarthritis
Phase 3 trial testing 10 cc of oxygen-ozone plus thumb splint in Thumb Osteoarthritis in 43 participants. Completed in 23 December 2022.
23 July 2022
Quick facts
| Lead sponsor | Humanitas Clinical and Research Center |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 1 May 2021 |
| Primary completion | 23 July 2022 |
| Estimated completion | 23 December 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- 10 cc of oxygen-ozone plus thumb splint — full drug profile →
- thumb splint
Conditions studied
- Thumb Osteoarthritis — all drugs for Thumb Osteoarthritis →
Sponsor
Humanitas Clinical and Research Center
Who can join
18 and older, any sex, with Thumb Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Osteoarthritis of trapezio-metacarpal joint (TMJ) most commonly occurs in women over 50 years old, often bilateral and it is a disabling condition presenting with pain at base of the thumb, swelling, instability, deformity and impairment of hand function with limitation in gripping and pinching objects. There are several surgical treatment options for TMJO as well as many conservative treatments such as splinting, thumb strengthening exercises, anti-inflammatory drugs and intra-articular injections. There are no currently approved TMJO treatments capable of slowing OA-related structural progression, so the main goals of the conservative treatment are to provide symptomatic relief, improve joint function, and delay surgical intervention. In recent years, the interest in the use of ozone is in constant increase especially because of the biological properties of inducing analgesia, anti-inflammatory, and antioxidant effects. Some articles have reported promising results on the effectiveness of oxygen-ozone, but the evidence is low. So, the aim of this study is to evaluate the effectiveness of intra-articular oxygen-ozone therapy (OOT) combined with thumb splint and compare it with only the splint therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07171840
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Thumb Osteoarthritis
Currently open trials in the same condition.
- NCT07566507 — High-Energy Laser in the Conservative Treatment of Rhizarthrosis · NA · recruiting
- NCT05992883 — NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis · Phase 3 · recruiting
- NCT04828954 — Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb · NA · recruiting
- NCT04210687 — Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis · NA · active not recruiting
Other Humanitas Clinical and Research Center trials
Trials by the same sponsor.
- NCT07161297 — Remimazolam for Colonoscopy in IBD Patients · Phase 4 · not yet recruiting
- NCT04934943 — "Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools" · not yet recruiting
- NCT06394947 — Fluid Challenge in Intensive Care The FENICE II Study · completed
- NCT06627907 — Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room. · not yet recruiting
- NCT06099171 — Therapy With Paravertebral Oxygen-ozone Injections and Topical Cannabidiol and β-Caryophyllene Patch in Neck Pain · Phase 3 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07171840 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Humanitas Clinical and Research Center
- Last refreshed: 26 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07171840.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing