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Taking people in ItalyNo phase

High-Energy Laser in the Conservative Treatment of Rhizarthrosis

Key facts

Who runs it
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Where
Bari, ItalySee the site
Trial code
Status
Recruiting
People taking part
42 people, planned
Started
1 Nov 2025
Expected to end
1 Dec 2028
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • THEAL:Ixyon XP (Mectronic, Bergamo, Italy)
Record updated
15 May 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 in Italy

  • Angela NotarnicolaBari, ItalyContact: Angela NotarnicolaTaking people

About the trial

What the trial wants to find out

Osteoarthritis (OA) is a degenerative joint disease that can affect the hands and is particularly debilitating when it involves the trapeziometacarpal joint (rhizarthrosis). It causes pain, deformity, limited movement and strength, joint instability, resulting in significant limitations in daily activities.Many conservative treatments, such as medications, therapeutic exercises, physical therapy, and orthoses, are effective for managing hand OA. For patients who do not respond to conservative treatments, surgical intervention will be necessary.

The 2 groups in the trial

  • High Intenisity Lasertherapy groupTreatment being tested

    The high-energy, multimodal laser therapy with thermal control (THEAL) will be administered using an Ixyon XP device (Mectronic, Bergamo, Italy), which allows the delivery of 4 wavelengths (650 nm, 810 nm, 980 nm, and 1064 nm) in continuous and pulsed mode, with an average power of up to 30 W, administering 10 sessions on alternate days.

    Treatment: THEAL:Ixyon XP (Mectronic, Bergamo, Italy)

  • Exercise groupNo study treatment, for comparison

    Patients will perform exercises for 4 weeks following recruitment. Patients in this group will be taught home exercises to improve the dynamic stability of the thumb metacarpal trapezius joint. The patient is instructed to perform a flexion of the trapeziometacarpal. If the individual is able to complete 10 repetitions with good technique, resistance will be added manually or with rubber bands. If this exercise is painful, they are asked to return to active movement only. Patients in both groups will be instructed to use a brace during the day for 4 weeks following recruitment.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
High Intensity Laser Therapy (HL) vs Exercise in Thumb Osteoarthritis
Record updated
15 May 2026