Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07566507

High Intensity Laser Therapy vs Exercise in Thumb Osteoarthritis A Randomized Study Using Ixyon XP Device for Rhizarthrosis Treatment

Led by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Updated on 2026-05-15

42

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

High-Energy Laser in the Conservative Treatment of Rhizarthrosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Arthrosis of the trapezoid-metacarpal joint at stage 1 or 2 by Eaton-Littler radiographic classification with a recent X-ray within 6 months
  • Clinical symptoms lasting at least 6 months
  • Pain scored at least 4 out of 10 on the Visual Analog Scale (VAS)
Not Eligible

You will not qualify if you...

  • Rheumatoid arthritis or trauma outcomes in the affected area
  • Contraindications to laser therapy such as neoplasia, pregnancy, thrombocytopenia, epilepsy, uncompensated heart disease or arrhythmia, pacemaker, or local infections
  • Corticosteroid injections or physical therapy within the previous 4 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

Angela Notarnicola

Bari, Italy, 70124

Actively Recruiting

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Research Team

A

angela notarnicola

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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

Effect of a stabilization exercise program versus standard treatment for thumb carpometacarpal osteoarthritis: A randomized trial.

Katie Pisano, Terri Wolfe, John Lubahn...

https://pubmed.ncbi.nlm.nih.gov/35811182

The effect of individual isometric muscle loading on the alignment of the base of the thumb metacarpal: a cadaveric study.

N Mobargha, M Esplugas, M Garcia-Elias...

https://pubmed.ncbi.nlm.nih.gov/26253421

Effects of a dynamic stability approach in conservative intervention of the carpometacarpal joint of the thumb: a retrospective study.

Virginia H O'Brien, M Russell Giveans

https://pubmed.ncbi.nlm.nih.gov/23177671

EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT).

W Zhang, M Doherty, B F Leeb...

https://pubmed.ncbi.nlm.nih.gov/17046965

American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee.

Marc C Hochberg, Roy D Altman, Karine Toupin April...

https://pubmed.ncbi.nlm.nih.gov/22563589