High-Energy Laser in the Conservative Treatment of Rhizarthrosis (HLEX-TO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Thumb Osteoarthritis; Hand Injuries; Laser
• Intervention / Treatment: Device: THEAL:Ixyon XP (Mectronic, Bergamo, Italy)

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: angela notarnicola; Phone Number: +393385678124; Email: angela.notarnicola@uniba.it

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Angela Notarnicola
    • Contact: Angela Notarnicola; Phone Number: 0805592938; Email: angelanotarnicola@yahoo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Exercise group; 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.
Experimental: High Intenisity Lasertherapy group; 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.	Device: THEAL:Ixyon XP (Mectronic, Bergamo, Italy); laser therapy; Other Names: High Intensity laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery of pain	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."	change between baseline to 1 month
recovery of pain	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."	change between baseline to 3 month
recovery of pain	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."	change between baseline to 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional recovery	The 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.	change between baseline to 1 month
perception of clinical improvement	Maudsley and Roles scale scores range from 0-4 points for excellent to poor	change between 3 to 6 months
functional recovery	The 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.	change between baseline to 3 month
functional recovery	The 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.	change between baseline to 6 month
disability recovery	The 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	change between baseline to 1 month
disability recovery	The 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	change between baseline to 3 month
disability recovery	The 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	change between baseline to 6 month

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Publications and helpful links

General Publications

• Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Gorska I. 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). Ann Rheum Dis. 2007 Mar;66(3):377-88. doi: 10.1136/ard.2006.062091. Epub 2006 Oct 17.
• Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.
• Medina-Porqueres I, Cantero-Tellez R. Class IV laser therapy for trapeziometacarpal joint osteoarthritis: Study protocol for a randomized placebo-controlled trial. Physiother Res Int. 2018 Apr;23(2):e1706. doi: 10.1002/pri.1706. Epub 2018 Mar 9.
• Pellegrini VD Jr. Osteoarthritis at the base of the thumb. Orthop Clin North Am. 1992 Jan;23(1):83-102.
• Mobargha N, Esplugas M, Garcia-Elias M, Lluch A, Megerle K, Hagert E. The effect of individual isometric muscle loading on the alignment of the base of the thumb metacarpal: a cadaveric study. J Hand Surg Eur Vol. 2016 May;41(4):374-9. doi: 10.1177/1753193415597114. Epub 2015 Aug 6.
• O'Brien VH, Giveans MR. Effects of a dynamic stability approach in conservative intervention of the carpometacarpal joint of the thumb: a retrospective study. J Hand Ther. 2013 Jan-Mar;26(1):44-51; quiz 52. doi: 10.1016/j.jht.2012.10.005. Epub 2012 Nov 21.
• Henry KD, Rosemond C, Eckert LB. Effect of number of home exercises on compliance and performance in adults over 65 years of age. Phys Ther. 1999 Mar;79(3):270-7.
• Pisano K, Wolfe T, Lubahn J, Cooney T. Effect of a stabilization exercise program versus standard treatment for thumb carpometacarpal osteoarthritis: A randomized trial. J Hand Ther. 2023 Jul-Sep;36(3):546-559. doi: 10.1016/j.jht.2022.03.009. Epub 2022 Jul 8.
• Moulton MJ, Parentis MA, Kelly MJ, Jacobs C, Naidu SH, Pellegrini VD Jr. Influence of metacarpophalangeal joint position on basal joint-loading in the thumb. J Bone Joint Surg Am. 2001 May;83(5):709-16. doi: 10.2106/00004623-200105000-00009.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; hand; conservative; lasertherapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Behavior; Hand Injuries; Motor Activity
• Other Study ID Numbers: HLEX-TO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No