Ireland
--:--IST
Recruiting Not applicable

High-Energy Laser in the Conservative Treatment of Rhizarthrosis

NCT07566507 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-11-01
Last updated
2026-05-15

Condition(s) studied

Thumb OsteoarthritisHand InjuriesLaserExercise

Investigational drug(s) / intervention(s)

THEAL:Ixyon XP (Mectronic, Bergamo, Italy)

THEAL:Ixyon XP (Mectronic, Bergamo, Italy): laser therapy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • recovery of pain — change between baseline to 1 month
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
  • recovery of pain — change between baseline to 3 month
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
  • recovery of pain — change between baseline to 6 month
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Trial sites (1)

FacilityCityRegionStatus
Angela Notarnicola Bari Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07566507 on ClinicalTrials.gov ↗ ← All trials in Italy