Terapia a laser de alta intensidade (class IV) e fonoforese em gel de ibuprofeno para o tratamento de osteoartrite de joelho entre pessoas que vivem em terreno montanhoso: um protocolo de ensaio multicêntrico, duplo-cego randomizado

Autores

DOI:

https://doi.org/10.17267/2238-2704rpf.2022.e4674

Palavras-chave:

Osteoartrite do joelho, Morro acima, Caminhada inclinada, Degeneração, Terapia a laser, Ultrassom

Resumo

INTRODUÇÃO: Pessoas que vivem em terrenos íngremes com carga cíclica anormal podem levar à degeneração da cartilagem óssea. A terapia a laser de alta intensidade (TLAI) e a fonoforese trazem inúmeros benefícios aos pacientes com osteoartrite de joelho (OAJ). No entanto, ainda não está claro qual tratamento é eficaz entre eles na reabilitação de pacientes com OAJ. OBJETIVO: Verificar se a TLAI de 8 semanas não é pior que a fonoforese em gel de ibuprofeno (FGI) no tratamento de pacientes com osteoartrite de joelho que vivem em terreno montanhoso. MATERIAIS E MÉTODOS: Um total de 108 indivíduos com OAJ serão recrutados por amostragem aleatória simples para participar de um estudo randomizado, duplo-cego e controlado. Os indivíduos recrutados com OAJ serão divididos aleatoriamente em dois grupos, grupo TLAI (grupo experimental) e grupo FGI (grupo controle). A duração do tratamento de TLAI e FGI será de 8 minutos em uma sessão/articulação do joelho para cada dia, por 3 dias/semana até 8 semanas, além de seus exercícios convencionais por 30 minutos. O Western Ontario and Mc Master Universities Osteoarthritis Index, o algômetro digitalizado de pressão de dor e o questionário de 36 itens Short-Form Health Survey são as medidas de resultado que serão registradas ao término, no final do período pós-intervenção de 8 semanas. PERSPECTIVAS: Os resultados deste ensaio contribuirão para recomendações baseadas em evidências para a implicação clínica de que o TLAI não é pior que o FGI juntamente com a intervenção de exercício para tratar indivíduos com OAJ que vivem em terreno íngreme.

Registro de Ensaios: Registro de Ensaios Clínicos (NCT04320914)

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Biografia do Autor

  • Asir John Samuel, Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), India

    ORCID - 0000-0003-1747-0415

Referências

(1) Fransen M, Bridgett L, March L, Hoy D, Penserga E, Brooks P. The epidemiology of osteoarthritis in Asia. Int J Rheum Dis. 2011;14(2):113–21.https://doi.org/10.1111/j.1756-185x.2011.01608.x

(2) Buckwalter J, Saltzman C, Brown T. The Impact of Osteoarthritis Implications for Research. Clin Orthop Relat Res. 2004;427(1):6–15. https://doi.org/10.1097/01.blo.0000143938.30681.9d

(3) Silverwood V, Blagojevic-Bucknall M, Jinks C, Jordan JL, Protheroe J, Jordan KP. Current evidence on risk factors for knee osteoarthritis in older adults: a systematic review and meta-analysis. Osteoarthr Cartil. 2015;23(4):507–15. https://doi.org/10.1016/j.joca.2014.11.019

(4) Kulandaivelan S, Tigdania N, Ateef M, Chaturvedi R, Joshi S, Malik A, et al. Prevalence of knee pain and its correlates with specific emphasis on CVD risk factors in Hisar urban population. Int J Clin Rheumtol [Internet]. 2017;12(4):91–6. Available from: https://www.openaccessjournals.com/articles/prevalence-of-knee-pain-and-its-correlates-with-specific-emphasis-on-cvd-risk-factors-in-hisar-urban-population-12133.html

(5) Ateef M, Kulandaivelan S, Alqahtani M. Cross-Cultural Validation of Urdu Version KOOS in Indian Population with Primary Knee Osteoarthritis. Int J Rheumatol. 2017;2017:1206706. https://doi.org/10.1155%2F2017%2F1206706

(6) Pal CP, Singh P, Chaturvedi S, Pruthi KK, Vij A. Epidemiology of knee osteoarthritis in India and related factors. Indian J Orthop. 2016;50(5):518–22. https://doi.org/10.4103/0019-5413.189608

(7) Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The Chronic Osteoarthritis Management Initiative of the U.S. Bone and Joint Initiative. Semin Arthritis Rheum. 2014;43(6):701–12. https://doi.org/10.1016/j.semarthrit.2013.11.012

(8) Braghin RMB, Libardi EC, Junqueira C, Rodrigues NC, Nogueira-Barbosa MH, Renno ACM, et al. The effect of low-level laser therapy and physical exercise on pain, stiffness, function, and spatiotemporal gait variables in subjects with bilateral knee osteoarthritis: a blind randomized clinical trial. Disabil Rehabil. 2018;1–8. https://doi.org/10.1080/09638288.2018.1493160

(9) Alqualo-Costa R, Thome GR, Perracini MR, Liebano RE. Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol. Pain Manag. 2018;8(3):157–66. https://doi.org/10.2217/pmt-2017-0057

(10) Paolillo FR, Paolillo AR, Joao JP, Frasca D, Duchene M, Joao HA, et al. Ultrasound plus low-level laser therapy for knee osteoarthritis rehabilitation: a randomized, placebo-controlled trial. Rheumatol Int. 2018;38(5):785–93. https://doi.org/10.1007/s00296-018-4000-x

(11) Alfredo PP, Bjordal JM, Junior WS, Lopes-Martins RAB, Stausholm MB, Casarotto RA, et al. Long-term results of a randomized, controlled, double-blind study of low-level laser therapy before exercises in knee osteoarthritis: laser and exercises in knee osteoarthritis. Clin Rehabil. 2018;32(2):173–8. https://doi.org/10.1177/0269215517723162

(12) Melo MO, Pompeo KD, Baroni BM, Vaz MA. Effects of neuromuscular electrical stimulation and low-level laser therapy on neuromuscular parameters and health status in elderly women with knee osteoarthritis: A randomized trial. J Rehabil Med. 2016;48(3):293–9. https://doi.org/10.2340/16501977-2062

(13) Nakamura T, Ebihara S, Ohkuni I, Izukura H, Harada T, Ushigome N, et al. Low Level Laser Therapy for chronic knee joint pain patients. Laser Ther. 2014;23(4):273–7. https://doi.org/10.5978/islsm.14-OR-21

(14) Mosiejczuk H, Bak K, Szylinska A, Ptak M, Mikolajczyk A, Lubinska A, et al. [Effect of low -level laser therapy and exercise in reducing the symptoms of disease in patients with osteoarthritis of the knee]. Pomeranian J life Sci. 2015;61(4):368–74.https://doi.org/10.21164/pomjlifesci.312

(15) Melo MO, Pompeo KD, Brodt GA, Baroni BM, da Silva Junior DP, Vaz MA. Effects of neuromuscular electrical stimulation and low-level laser therapy on the muscle architecture and functional capacity in elderly patients with knee osteoarthritis: a randomized controlled trial. Clin Rehabil. 2015;29(6):570–80. https://doi.org/10.1177/0269215514552082

(16) Soleimanpour H, Gahramani K, Taheri R, Golzari SEJ, Safari S, Esfanjani RM, et al. The effect of low-level laser therapy on knee osteoarthritis: prospective, descriptive study. Lasers Med Sci. 2014;29(5):1695–700. https://doi.org/10.1007/s10103-014-1576-6

(17) Kheshie AR, Alayat MSM, Ali MME. High-intensity versus low-level laser therapy in the treatment of patients with knee osteoarthritis: a randomized controlled trial. Lasers Med Sci. 2014;29(4):1371–6. https://doi.org/10.1007/s10103-014-1529-0

(18) Al Rashoud AS, Abboud RJ, Wang W, Wigderowitz C. Efficacy of low-level laser therapy applied at acupuncture points in knee osteoarthritis: a randomised double-blind comparative trial. Physiotherapy. 2014;100(3):242–8. https://doi.org/10.1016/j.physio.2013.09.007

(19) Alghadir A, Omar MTA, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014;29(2):749–55. https://doi.org/10.1007/s10103-013-1393-3

(20) Alfredo PP, Bjordal JM, Dreyer SH, Meneses SRF, Zaguetti G, Ovanessian V, et al. Efficacy of low level laser therapy associated with exercises in knee osteoarthritis: a randomized double-blind study. Clin Rehabil. 2012;26(6):523–33. https://doi.org/10.1177/0269215511425962

(21) Fukuda VO, Fukuda TY, Guimaraes M, Shiwa S, de Lima BDC, Martins RABL, et al. Short-term efficacy of low-level laser therapy in patients with knee osteoarthritis: a randomized placebo-controlled, double-blind clinical trial. Rev Bras Ortop. 2011;46(5):526–33. https://doi.org/10.1016/s2255-4971(15)30407-9

(22) Hegedus B, Viharos L, Gervain M, Galfi M. The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial. Photomed Laser Surg. 2009;27(4):577–84. https://doi.org/10.1089/pho.2008.2297

(23) Stiglic-Rogoznica N, Stamenkovic D, Frlan-Vrgoc L, Avancini-Dobrovic V, Vrbanic TS-L. Analgesic effect of high intensity laser therapy in knee osteoarthritis. Coll Antropol. 2011;35(2):183–5. Cited: PMID: 222204331

(24) Huang Z, Chen J, Ma J, Shen B, Pei F, Kraus VB. Effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthr Cartil. 2015;23(9):1437–44. https://doi.org/10.1016/j.joca.2015.04.005

(25) World Medical Association. World Medical Organisation Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191-94. https://doi.org/10.1001/jama.2013.281053

(26) Council for International Organization of Medical Sciences (CIOMS). International Ethical Guidelines for Health-related Research Involving Humans [Internet]. Biomedical Research. 2016. Available from: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

(27) Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986;29(8):1039–49. https://doi.org/10.1002/art.1780290816

(28) Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167(1):40–7. https://doi.org/10.7326/m17-0046

(29) Gupta KK, Attri JP, Singh A, Kaur H, Kaur G. Basic concepts for sample size calculation: Critical step for any clinical trials! Saudi J Anaesth. 2016;10(3):328–31. https://doi.org/10.4103/1658-354X.174918

(30) Salehi R, Valizadeh L, Negahban H, Karimi M, Goharpey S, Shahali S. The Western Ontario and McMaster Universities Osteoarthritis, Lequesne Algofunctional index, Arthritis Impact Measurement Scale-short form, and Visual Analogue Scale in patients with knee osteoarthritis: responsiveness and minimal clinically important differences. https://doi.org/101080/0963828820222084776 [Internet]. 2022 [cited 2022 Sep 16]; Available from: https://www.tandfonline.com/doi/abs/10.1080/09638288.2022.2084776

(31) Leeuwen RJ, Szadek K, de Vet H, Zuurmond W, Perez R. Prospective evaluation Pain Pressure Threshold in the Region of the Sacroiliac Joint in Patients Diagnosed with Sacroiliac Joint Pain. Pain Physician. 2016;19(3):147–54. Cited: PMID: 27008288

(32) Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–40.

(33) Alkan BM, Fidan F, Tosun A, Ardicoglu O. Quality of life and self-reported disability in patients with knee osteoarthritis. Mod Rheumatol. 2014;24(1):166–71. https://doi.org/10.3109/14397595.2013.854046

(34) Araujo ILA, Castro MC, Daltro C, Matos MA. Quality of Life and Functional Independence in Patients with Osteoarthritis of the Knee. Knee Surg Relat Res. 2016;28(3):219–24. https://doi.org/10.5792/ksrr.2016.28.3.219

(35) Larkin KA, Cat C, Martin JS, Elizabeth H, True JM, Braith RW, et al. Limb Blood Flow After Class 4 Laser Therapy. J Athl Train. 2012;47(2):178–83. https://doi.org/10.4085/1062-6050-47.2.178

(36) Kozanoglu E, Basaran S, Guzel R, Guler-Uysal F. Short term efficacy of ibuprofen phonophoresis versus continuous ultrasound therapy in knee osteoarthritis. Swiss Med Wkly. 2003;133(23–24):333–8. Cited: PMID: 12923684

(37) Nejati P, Farzinmehr A, Moradi-Lakeh M. The effect of exercise therapy on knee osteoarthritis: a randomized clinical trial. Med J Islam Repub Iran. 2015;29:186. Cited: PMID: 26034739

(38) Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane database Syst Rev. 2008;(4):CD004376–CD004376. https://doi.org/10.1002/14651858.cd004376.pub2

(39) D'Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues – the encounters of academic consultants in statistics. Stat Med. 2003;22(2):169–86. https://doi.org/10.1002/sim.1425

(40) Walker J. Non-inferiority statistics and equivalence studies. BJA Educ. 2019;19(8):267–71. https://doi.org/10.1016/j.bjae.2019.03.004

(41) Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91. https://doi.org/10.3758/bf03193146

(42) Angelova A, Ilieva EM. Effectiveness of high intensity laser therapy for reduction of pain in knee osteoarthritis. Pain Res Manag. 2016;2016. https://doi.org/10.1155/2016/9163618

(43) Santamato A, Solfrizzi V, Panza F, Tondi G, Frisardi V, Leggin BG, et al. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of people with subacromial impingement syndrome: A randomized clinical trial. Phys Ther. 2009;89(7):643–52. https://doi.org/10.2522/ptj.20080139

(44) Fiore P, Panza F, Cassatella G, Russo A, Frisardi V, Solfrizzi V, et al. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of low back pain: A Randomized controlled trial. Eur J Phys Rehabil Med. 2011;47(3):367–73. Cited: PMID: 21654616

Publicado

21.12.2022

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Terapia a laser de alta intensidade (class IV) e fonoforese em gel de ibuprofeno para o tratamento de osteoartrite de joelho entre pessoas que vivem em terreno montanhoso: um protocolo de ensaio multicêntrico, duplo-cego randomizado. (2022). Revista Pesquisa Em Fisioterapia, 12, e4674. https://doi.org/10.17267/2238-2704rpf.2022.e4674