High-energy laser treatment for thumb osteoarthritis (rhizarthrosis)
Official title: High Intensity Laser Therapy (HL) vs Exercise in Thumb Osteoarthritis
Run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · NCT07566507 · Data updated 2026-11-12
This trial will test whether high-energy laser therapy using the THEAL Ixyon XP can reduce pain and improve function in people with early-stage thumb base osteoarthritis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Bari) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2028 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT07566507 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with at least six months of thumb base osteoarthritis symptoms, Eaton-Littler radiographic stage 1–2, and a pain score of 4/10 or higher who have not had recent corticosteroid injections or physical therapy.
✕Probably not a fit
Patients with advanced (late-stage) thumb arthritis, inflammatory arthritis, recent local trauma, pregnancy, pacemakers, active local infection, or other contraindications are unlikely to be eligible or to benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with symptomatic trapeziometacarpal (thumb base) osteoarthritis at Eaton-Littler stage 1–2 and pain of at least 4/10 are randomized to receive high-energy laser therapy using the THEAL Ixyon XP as part of conservative care or to a control regimen. Treatments are delivered in clinic with standardized protocols and patients are followed for changes in pain, hand function, and related outcomes over weeks to months. Key exclusions include rheumatoid arthritis, recent steroid injection or physical therapy, local infection, pregnancy, implantable electronic devices, and other contraindications to laser. The trial is designed to test whether deep-penetrating high-energy laser provides clinically meaningful and durable symptom relief compared with control.
Why it matters
Potential benefit: If successful, this could offer a non-surgical option that reduces thumb base pain and improves hand function, potentially delaying or avoiding surgery.
How similar studies have gone: Small randomized trials (for example Cantero-Téllez 2020 and Guo 2023) reported short-term pain relief with high-energy laser but benefits often waned by about 12 weeks, so the approach is promising but evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * arthrosis of the trapezoid-metacarpal with stage 1 or 2 of the Eaton-Littler radiographic classification and pain (recent radiograph within 6 months previously); * clinical picture that has been occurring for at least 6 months; * pain scored with VAS scale at least 4/10. Exclusion Criteria: * rheumatoid arthritis or outcomes of trauma in the affected area, contra-indications to treatment with laser therapy (neoplasia, pregnancy, thrombocytopenia, epilepsy, uncompensated heart disease or arrhythmia, pacemaker, local infections), * corticosteroid infiltration or physical therapy in the previous 4 weeks.
Where it's running
-
Angela Notarnicola
Bari, Italy Recruiting
Study contacts
- Study coordinator: angela notarnicola
- Email: angela.notarnicola@uniba.it
- Phone: +393385678124
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.