High-Energy Laser in the Conservative Treatment of Rhizarthrosis: A Prospective Randomized Controlled Clinical Study

NCT07566507 | Recruiting

• 1 other identifier: HLEX-TO
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Thumb Osteoarthritis; Hand Injuries; Laser; Exercise

Keywords

hand; rehabilitation; conservative; lasertherapy; exercise

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• functional recovery

  change between baseline to 1 month

• functional recovery

  change between baseline to 3 month

• functional recovery

  change between baseline to 6 month

• disability recovery

  change between baseline to 1 month

• disability recovery

  change between baseline to 3 month

Study Arms (2)

High Intenisity Lasertherapy group

EXPERIMENTAL

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)

Exercise group

NO INTERVENTION

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.

Interventions

THEAL:Ixyon XP (Mectronic, Bergamo, Italy) DEVICE

laser therapy

Also known as: High Intensity laser therapy

High Intenisity Lasertherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

Angela Notarnicola

Bari, 70124, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 29520953 RESULT

• K. Pisano, T. Wolfe, J. Lubahn et al., Effect of a stabilization exercise program versus standard treatment for thumb carpometacarpal osteoarthritis: A randomized trial. J Hand Ther 2022 Jul 7;S0894-1130(22)00040-0.

  RESULT

• Moulton MJ, Parentis MA, Kelly MJ, Jacobs C, Naidu SH, Pelle- grini VD. Influence of metacarpophalangeal joint position on basal joint-loading in the thumb. J Bone Joint Surg Am . 2001;83:709-716

  RESULT

• Pellegrini VD Jr. Osteoarthritis at the base of the thumb. Orthop Clin North Am. 1992 Jan;23(1):83-102.

  PMID: 1729673 RESULT

• 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.

  PMID: 26253421 RESULT

• 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.

  PMID: 23177671 RESULT

• 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.

  PMID: 10078770 RESULT

• Zhang W, Doherty M, Leeb BF, et al. 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;66:377-88

  RESULT

• 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.

  PMID: 22563589 RESULT

MeSH Terms

Conditions

Hand Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Behavior

Central Study Contacts

angela notarnicola

CONTACT

+393385678124; angela.notarnicola@uniba.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized prospective

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 5, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)