High-intensity laser therapy (class IV) and ibuprofen gel phonophoresis for treating knee osteoarthritis among people living in hilly terrain: a randomized, double blind, multi-centre trial protocol

Authors

DOI:

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

Keywords:

Knee osteoarthritis, Uphill, Incline walking, Degeneration, Laser therapy, Ultrasound

Abstract

INTRODUCTION: People living in hilly terrain with abnormal cyclic loading could lead to bone cartilage degeneration. High-intensity laser therapy (HILT) and Ibuprofen gel phonophoresis (IGP) have innumerable benefits for patients with knee osteoarthritis (KOA). However, it is still unclear which treatment is effective among them in rehabilitating patients with KOA. OBJECTIVE: To verify whether 8-week HILT is no worse than the IGP in treating patients with knee osteoarthritis living in hilly terrain. MATERIALS AND METHODS: A total of 108 individuals with KOA will be recruited by simple random sampling to participate in a randomized, double-blind, controlled study. Recruited individuals with KOA will be randomly divided into two groups, the HILT group (experimental group) and the IGP group (active control group). The treatment duration of HILT and IGP will be 8 minutes in one session/knee joint for each day for 3 days/week up to 8 weeks in addition to their conventional exercises for 30 minutes. The Western Ontario and McMaster Universities Osteoarthritis Index, Digitalized pain pressure algometer, and 36-Item Short-Form Health Survey questionnaire are the outcome measures that will be recorded at baseline, end of the 8-week post-intervention period. PERSPECTIVES: The results from this trial will contribute to evidence-based recommendations for the clinical implication of whether HILT is no worse than IGP, along with exercise intervention for treating individuals with KOA living in hilly terrain.

Trial Registry: Clinical Trials Registry (NCT04320914)

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Author Biography

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

    ORCID - 0000-0003-1747-0415

References

(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

Published

12/21/2022

Issue

Section

Methods & Protocols

How to Cite

1.
Srivastav AK, Saini V, Sharma D, Samuel AJ. High-intensity laser therapy (class IV) and ibuprofen gel phonophoresis for treating knee osteoarthritis among people living in hilly terrain: a randomized, double blind, multi-centre trial protocol . Rev Pesq Fisio [Internet]. 2022 Dec. 21 [cited 2024 May 18];12:e4674. Available from: https://journals.bahiana.edu.br/index.php/fisioterapia/article/view/4674