High-energy laser treatment for thumb osteoarthritis (rhizarthrosis)
High Intensity Laser Therapy (HL) vs Exercise in Thumb Osteoarthritis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Bari) |
| Trial ID | NCT07566507 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bari
- Angela Notarnicola — Bari, Italy (Recruiting)
Study contacts
- Study coordinator: angela notarnicola
- Email: angela.notarnicola@uniba.it
- Phone: +393385678124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.