Journal of Research in Rehabilitation Sciences

Design of a Clinical Trial to Determine the Effects of Low Level Laser on Pain and Function in Patellofemoral Pain Syndrome: Protocol for a Triple-Blinded Randomized Clinical Trial

Document Type : Original Articles

Authors

1 MSc Student, Musculoskeletal Research Center AND Student Research Committee of Rehabilitation Students (Treata), Department of Physical Therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran

2 Department of Orthopedic Surgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

3 Assistant Professor, Department of Orthopaedic Surgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

4 Professor, Department of Health Professions, Manchester Metropolitan University AND Clinical Physiotherapy Specialist, Manchester Royal Infirmary AND Honorary Senior Lecturer, University of Manchester AND Honorary Senior Lecturer, University of Salford, Manchester, United Kingdom

5 Assistant Professor, Musculoskeletal Research Center, Rehabilitation Sciences Research Institute AND Department of Physical Therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran

10.22122/jrrs.v14i5.3414

Abstract

Introduction: We aimed to design a triple-blinded randomized clinical trial study to asssess the effect of low-level laser (LLL) on pain and function in patients with patellofemoral pain syndrome (PFPS).Materials and Methods: This designed study will involve 60 patientswith PFP syndrome. Eligible subjects will be divided randomly into control (physical therapy), physical therapy plus active LLL, and physical therapy plus placebo laser. The physical therapy program will be exactly the same for all groups including exercise and education for ten sessions, every other day. The LLL group will receive 808 nm, 200 mW, 4 J Ga-Al-As laser over 5 points for 20 seconds per point. The laser will be deactivated in placebo group, and for the control group, the laser will not be used. The outcomes include pain and function, which will be measured using visual analogue scale (VAS), the Persian version of the Kujala patellofemoral questionnaire, and the step down test. Following Shapiro-Wilk test, the paired t and one-way ANOVA tests, if data distribution followed normal distribution, or the Kruskal-Wallis and Mann Whitney tests, if data distribution did not follow normal distribution, will be administered at the significance level of less than 0.05.Conclusion: Therapeutic exercises is the treatment of choice for PFP syndrome. LLL is a commonly favorable modality prescribed as a part of physical therapy program for musculoskeletal disorders. However, the effect of laser in subjects with PFPS has not been thoroughly investigated. In designed study, it will be examined whether adding LLL to standard physical therapy has a clinical benefit in subjects with PFPS.

Keywords

  1. Lake DA, Wofford NH. Effect of therapeutic modalities on patients with patellofemoral pain syndrome: A systematic review. Sports Health 2011; 3(2): 182-9.
  2. Servodio IC, Cadossi M, Sambri A, Grosso E, Corrado B, Servodio IF. Is there a role of pulsed electromagnetic fields in management of patellofemoral pain syndrome? Randomized controlled study at one year follow-up. Bioelectromagnetics 2016; 37(2): 81-8.
  3. van der Heijden RA, Lankhorst NE, van Linschoten R, Bierma-Zeinstra SM, van Middelkoop M. Exercise for treating patellofemoral pain syndrome. Cochrane Database Syst Rev 2015; 1: CD010387.
  4. Mostamand J, Bader DL, Hudson Z. Reliability testing of the patellofemoral joint reaction force (PFJRF) measurement during double-legged squatting in healthy subjects: A pilot study. J Bodyw Mov Ther 2012; 16(2): 217-23.
  5. Martimbianco ALC, Torloni MR, Andriolo BN, Porfirio GJ, Riera R. Neuromuscular electrical stimulation (NMES) for patellofemoral pain syndrome. Cochrane Database Syst Rev 2017; 12: CD011289.
  6. Lun VM, Wiley JP, Meeuwisse WH, Yanagawa TL. Effectiveness of patellar bracing for treatment of patellofemoral pain syndrome. Clin J Sport Med 2005; 15(4): 235-40.
  7. Rogvi-Hansen B, Ellitsgaard N, Funch M, Dall-Jensen M, Prieske J. Low level laser treatment of chondromalacia patellae. Int Orthop 1991; 15(4): 359-61.
  8. Akbari A, Naroii S, Karami S, Shahraki H. The effect of low-level LASER on pain improvement and function in patients affected anterior knee pain. J Shahrekord Univ Med Sci 2011; 13(5): 11-9. [In Persian].
  9. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken) 2011; 63(Suppl 11): S240-S252.
  10. Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater reliability of functional performance tests for subjects with patellofemoral pain syndrome. J Athl Train 2002; 37(3): 256-61.
  11. Sahin M, Ayhan FF, Borman P, Atasoy H. The effect of hip and knee exercises on pain, function, and strength in patientswith patellofemoral pain syndrome: A randomized controlled trial. Turk J Med Sci 2016; 46(2): 265-77.
  12. Ittenbach RF, Huang G, Barber Foss KD, Hewett TE, Myer GD. Reliability and validity of the Anterior Knee Pain Scale: Applications for use as an epidemiologic screener. PLoS One 2016; 11(7): e0159204.
  13. Moyano FR, Valenza MC, Martin LM, Caballero YC, Gonzalez-Jimenez E, Demet GV. Effectiveness of different exercises and stretching physiotherapy on pain and movement in patellofemoral pain syndrome: A randomized controlled trial. Clin Rehabil 2013; 27(5): 409-17.
  14. Negahban H, Pouretezad M, Yazdi MJ, Sohani SM, Mazaheri M, Salavati M, et al. Persian translation and validation of the Kujala Patellofemoral Scale in patients with patellofemoral pain syndrome. Disabil Rehabil 2012; 34(26): 2259-63.
  15. Robertson V, Ward A, Low J, Reed A. Electrotherapy explained: Principles and practice. Edinburgh, UK: Elsevier Health Sciences; 2006.
  16. Tuner J, Hode L. The new laser therapy handbook: A guide for research scientists, doctors, dentists, veterinarians and other interested parties within the medical field. Grangesberg, Sweden: Prima Books; 2010.
  17. WALT. Recommended treatment doses for Low Level Laser Therapy [Online]. [cited 2010 Apr]; Available from: URL: https://waltza.co.za/wp-content/uploads/2012/08/Dose_table_904nm_for_Low_Level_Laser_Therapy_WALT-2010.pdf
  18. Crossley KM, van Middelkoo M, Callaghan MJ, Collins NJ, Rathleff MS, Barton CJ. 2016 Patellofemoral pain consensus statement from the 4th International Patellofemoral Pain Research Retreat, Manchester. Part 2: recommended physical interventions (exercise, taping, bracing, foot orthoses and combined interventions). Br J Sports Med 2016; 50(14): 844-52.
  19. Fukuda T, Melo W, Zaffalon B, Rossetto F, Magalhaes E, Bryk F, et al. Hip posterolateral musculature strengthening in sedentary women with patellofemoral pain syndrome: A randomized controlled clinical trial with 1-year follow-up. J Orthop Sports Phys Ther 2012; 42(10): 823-30.
  20. 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.
  21. Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behav Res Methods 2009; 41(4): 1149-60.
  22. Clijsen R, Fuchs J, Taeymans J. Effectiveness of exercise therapy in treatment of patients with patellofemoral pain syndrome: Systematic review and meta-analysis. Phys Ther 2014; 94(12): 1697-708.
  23. Barton CJ, Lack S, Hemmings S, Tufail S, Morrissey D. The 'Best Practice Guide to Conservative Management of Patellofemoral Pain': Incorporating level 1 evidence with expert clinical reasoning. Br J Sports Med 2015; 49(14): 923-34.
  24. Can F, Tandogan R, Yilmaz I, Dolunay E, Erden Z. Rehabilitation of patellofemoral pain syndrome: TENS versus diadynamic current therapy for pain relief. The Pain Clinic 2003; 15(1): 61-8.
Journal of Research in Rehabilitation Sciences
Volume 14, Issue 5 - Serial Number 5
November 2018
Pages 303-310
  • Receive Date: 09 December 2019
  • Revise Date: 01 June 2022
  • Accept Date: 22 May 2022