Class IV laser therapy for trapeziometacarpal joint osteoarthritis: Study protocol for a randomized placebo-controlled trial.
Ivan Medina-Porqueres, Raquel Cantero-Tellez
https://pubmed.ncbi.nlm.nih.gov/29520953/Actively Recruiting
Led by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Updated on 2026-05-15
42
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are investigating the use of high-energy laser therapy to treat thumb osteoarthritis, a degenerative joint disease that affects the hand and causes pain, deformity, and limited movement. This condition can significantly limit daily activities, especially when it involves the trapeziometacarpal joint, known as rhizarthrosis. Many treatments like medications, exercises, physical therapy, and orthoses help manage hand osteoarthritis, but surgery may be needed when these conservative treatments fail. The study compares two approaches high-energy multimodal laser therapy using the Ixyon XP device, which delivers multiple wavelengths and is administered in 10 sessions on alternate days, versus a group performing home exercises designed to improve thumb joint stability over 4 weeks. Both groups will use a brace during the day for 4 weeks. The laser therapy aims to reduce inflammation, improve blood flow, and relieve pain by stimulating cellular activity in the affected tissues. Participants will be monitored for pain relief at 1, 3, and 6 months after treatment begins. Researchers will also assess functional recovery, disability improvement, and the participants perception of clinical progress over 6 months. The study involves regular evaluations of pain using a visual scale and assessments of hand function and disability to understand the benefits of high-energy laser therapy compared to exercise alone.
CONDITIONS
High-Energy Laser in the Conservative Treatment of Rhizarthrosis
A
angela notarnicola
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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either high-energy laser therapy using the Ixyon XP device or perform home exercises to improve thumb stability. Both groups use a brace during the day for 4 weeks following recruitment.
10 sessions on alternate days for laser therapy or home exercise instructions; brace use daily
Duration - Up to 6 months
Participants are monitored for recovery of pain, functional recovery, disability recovery, and perception of clinical improvement up to 6 months after treatment.
Visits at 1 month, 3 months, and 6 months post-treatment
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor