High-Energy Laser in the Conservative Treatment of Rhizarthrosis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• recovery of pain [Срок оценки: change between baseline to 1 month]
• recovery of pain [Срок оценки: change between baseline to 3 month]
• recovery of pain [Срок оценки: change between baseline to 6 month]

Вторичные конечные точки (7)

• functional recovery [Срок оценки: change between baseline to 1 month]
• functional recovery [Срок оценки: change between baseline to 3 month]
• functional recovery [Срок оценки: change between baseline to 6 month]
• disability recovery [Срок оценки: change between baseline to 1 month]
• disability recovery [Срок оценки: change between baseline to 3 month]
• disability recovery [Срок оценки: change between baseline to 6 month]
• perception of clinical improvement [Срок оценки: change between 3 to 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Angela Notarnicola — Bari

Публикации

• 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
• 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. PMID 35811182
• 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. PMID 11379740
• Pellegrini VD Jr. Osteoarthritis at the base of the thumb. Orthop Clin North Am. 1992 Jan;23(1):83-102. PMID 1729673
• 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
• 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
• 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
• 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 Int PMID 17046965

Идентификаторы

NCT: NCT07566507 · HLEX-TO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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