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High-Energy Laser in the Conservative Treatment of Rhizarthrosis

High Intensity Laser Therapy (HL) vs Exercise in Thumb Osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07566507
Acronym
HLEX-TO
Enrollment
42
Registered
2026-05-05
Start date
2025-11-01
Completion date
2028-12-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Hand Injuries, Laser, Thumb Osteoarthritis

Keywords

hand, rehabilitation, conservative, lasertherapy, exercise

Brief 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.

Detailed description

Among physical therapies, in recent years particular interest has been focused on the laser (Light Amplification through the Stimulated Emission of Radiation), which exploits the biological effects induced by electromagnetic emission, consisting of increased mitochondrial oxidation, which facilitates the formation of adenosine triphosphate (ATP), increased cellular metabolism, and blood circulation, with rapid absorption of edema and removal of exudates. These actions induce significant anti-inflammatory, proliferative, and analgesic effects on various orthopedic conditions. So far, low-energy lasers have been used in rehabilitative treatments. Currently, there is growing interest in using high-energy lasers, which have a greater ability to penetrate deeply into the tissues and to biostimulate the affected area.The first studies investigating the effects of high-energy laser in this pathology provide interesting results. Medina-Porqueres et al. in 2017 published a study protocol for high-energy laser treatment in rhizarthrosis, which involved randomization to experimental treatment or placebo, but to date the results have not been disclosed. Cantero-Téllez and colleagues (2020) treated 43 patients with rhizarthrosis, randomizing them to an experimental group (high-energy laser) or placebo. They found a remission of pain at the end of high-energy laser treatment, noting, however, that the benefits subsided within 12 weeks. Guo and colleagues (2023) also randomized 42 patients with rhizarthrosis to high-energy laser treatment with occupational therapy guidance or to short-wave treatment and orthosis; their experience has shown that experimental treatment with high-energy laser allowed for improvement in pain and pinch function of the thumb at 12 weeks. The aim of our study is to further investigate the therapeutic effectiveness of high-energy laser treatment in hand osteoarthritis.

Interventions

DEVICETHEAL:Ixyon XP (Mectronic, Bergamo, Italy)

laser therapy

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

randomized

Intervention model description

randomized prospective

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
recovery of painchange between baseline to 1 monthThe 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."

Secondary

MeasureTime frameDescription
functional recoverychange between baseline to 1 monthThe Functional Index of Hand Osteoarthritis (FIHOA) measures the effect of hand problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 30; the higher the score, the more limitation/pain/disability is present.
disability recoverychange between baseline to 1 monthThe Disabilities of the Arm, Shoulder and Hand Score (QuickDash) contains 11 questions related to ability and pain in the past week. Scores range from 0 to 100; the higher the score, the greater the limitation/pain/disability
perception of clinical improvementchange between 3 to 6 monthsMaudsley and Roles scale scores range from 0-4 points for excellent to poor

Countries

Italy

Contacts

CONTACTangela notarnicola
angela.notarnicola@uniba.it+393385678124

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026