The effect of systemic versus local transcutaneous laser therapy on tension-type cephalea and orofacial pain in post-COVID-19 patients: A pragmatic randomized clinical trial

Mayra Costanti Vilela Campos, Silvana Simoes Velloso Schuler, Pamella de Barros Motta, Adriana Cátia Mazzoni, Francine Cristina da Silva, Manoela Domingues Martins, Kristianne Porta Santos Fernandes, Raquel Agnelli Mesquita-Ferrari, Anna Carolina Ratto Tempestini Horliana, Sandra Kalil Bussadori, Lara Jansiski Motta, Mayra Costanti Vilela Campos, Silvana Simoes Velloso Schuler, Pamella de Barros Motta, Adriana Cátia Mazzoni, Francine Cristina da Silva, Manoela Domingues Martins, Kristianne Porta Santos Fernandes, Raquel Agnelli Mesquita-Ferrari, Anna Carolina Ratto Tempestini Horliana, Sandra Kalil Bussadori, Lara Jansiski Motta

Abstract

Introduction: Orofacial pain and tensional cephalea were symptoms commonly reported in COVID-19 patients, even after recovery, and were considered chronic pain in these cases. The aim of this research is to evaluate the effect of the application of photobiomodulation with red and infrared lasers applied locally and systemically.

Methods and analysis: For this purpose, individuals who have been diagnosed with COVID-19 and have had a tension headache and/or orofacial pain for more than 3 months will be selected by convenience. The participants will be divided into two different groups: G1-photobiomodulation with red and infrared laser with local application on the pain points (808 nm and 660 nm, 100 mW, 6 J per point) and G2-photobiomodulation with red laser with transcutaneous application on the radial artery (660 nm, 100 mW, 30 minutes). All participants will be treated for a period of 4 weeks, with 8 application sessions. The effects will be measured by means of blood lactate level, Brief Pain Inventory, Visual Analog Scale (VAS), and Cephalea Impact Test. The data will be collected weekly before and after the treatment, and the following tests will be applied: Analysis of variance (ANOVA), Tukey paired t test, Kruskal-Wallis, or Wilcoxon, according to data distribution. α = 0.05 will be considered as the level of statistical significance.

Ethics and dissemination: This study was approved by the Research Projects Committee of the Nove de Julho University (approval number 4.673.963). Results will be disseminated through peer-reviewed journals and events for the scientific and clinical community, and the general public. It is registered in the ClinicalTrials.gov database with the number NCT05430776.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

Figures

Figure 1.
Figure 1.
Schedule of enrollment, interventions, and assessments. This clinical trial will follow the consort (Consolidated Standards of Reporting Trials) recommendations. Figure 1 presents the flow chart of the research. BPI = Brief Pain Inventory, HIT-6 = Headache Impact Test, VAS = Visual Analog Scale.

References

    1. Shah N. [Internet] SHS, 2021 undefined. Muscle Contraction Tension Headache. [Internet]. [cited 2022 Jun 1]; Available at: .
    1. Leeuw R. Dor orofacial: guia de avaliação, diagnós – Google Scholar [Internet]. [cited 2022 Jun 1]. Available at: .
    1. Memmedova F, Emre U, Yalin OO, Doğan OC. Evaluation of temporomandibular joint disorder in headache patients. Neurol Sci. 2021;42:4503–9.
    1. Loder E, Rizzoli P. Tension-type headache. BMJ. 2008;336:88.
    1. de Pauw R, Dewitte V, Practice W de H… S, 2021 Undefined. Consensus among musculoskeletal experts for the management of patients with headache by physiotherapists? A Delphi study. Elsevier [Internet]. [cited 2022 Jun 1]; Available at: .
    1. Do TP, Heldarskard GF, Kolding LT, Hvedstrup J, Schytz HW. Myofascial trigger points in migraine and tension-type headache. J Headache Pain. 2018;19:84.
    1. Dalewski B, Kamińska A, MSPR and, 2019 Undefined. Comparison of early effectiveness of three different intervention methods in patients with chronic orofacial pain: a randomized, controlled clinical trial. [Internet]. [cited 2022 Jun 1]; Available at: .
    1. Lippi G, Mattiuzzi C, Bovo C, Henry BM. Headache is an important symptom in patients with coronavirus disease 2019 (COVID-19). Diagnosis. 2020;7:409–11.
    1. Martínez-Pías E, DGARev Neurol. Ed, 2021 Undefined. Migraña crónica con cefalea diaria. Revisión de la bibliografía. [Internet]. [cited 2022 Jun 1]; Available at: .
    1. Augusto P, Rocha-Filho S, Ao J, Magalh~Aes E. Headache associated with COVID-19: Frequency, characteristics and association with anosmia and ageusia. [Internet]. 2020. [cited 2022 Jun 1]; 40:1443–51. Available at: .
    1. Medeiros R, Vieira D. … ESJ of AO, 2020 Undefined. Prevalence of symptoms of temporomandibular disorders, oral behaviors, anxiety, and depression in Dentistry students during the period of social isolation. SciELO Brasil [Internet]. [cited 2022 Jun 1]; Available at: .
    1. Falla D, Asquini G, Bianchi AE, Borromeo G, Locatelli M. The impact of Covid-19-related distress on general health, oral behaviour, psychosocial features, disability and pain intensity in a cohort of Italian patients with temporomandibular disorders. PLoS One. 2021;16:e0245999.
    1. Almeida-Leite CM, Stuginski-Barbosa J, Conti PCR. How psychosocial and economic impacts of COVID-19 pandemic can interfere on bruxism and temporomandibular disorders? J Appl Oral Sci. 2020;28:e20200263.
    1. Uygun O, Ertaş M, Ekizoğlu E, et al. . Headache characteristics in COVID-19 pandemic-a survey study. J Headache Pain. 2020;21:121.
    1. Meneguzzo DT, Lopes LA, Pallota R, Soares-Ferreira L, Lopes-Martins RAB, Ribeiro MS. Prevention and treatment of mice paw edema by near-infrared low-level laser therapy on lymph nodes. Lasers Med Sci. 2013;28:973–80.
    1. Barretto S, de Melo G. JDS of P and, 2013 Undefined. Evaluation of anti-nociceptive and anti-inflammatory activity of low-level laser therapy on temporomandibular joint inflammation in rodents. Elsevier [Internet]. [cited 2022 Jun 1]; Available at: .
    1. Núñez SC, França CM, Silva DFT, Nogueira GEC, Prates RA, Ribeiro MS. The influence of red laser irradiation timeline on burn healing in rats. Lasers Med Sci. 2013;28:633–41.
    1. 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;29:749–55.
    1. França C, França C, Núñez S, RP of P and, 2009 Undefined. Low-intensity red laser on the prevention and treatment of induced-oral mucositis in hamsters. Elsevier [Internet]. [cited 2022 Jun 1]; Available at: .
    1. Paula Taboada Sobral A, Leal de Godoy CH, Santos Fernandes KP, et al. . Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis. [Internet]. 2018 [cited 2022 Jun 1];8:18326. Available at: .
    1. Magri LV, Carvalho VA, Rodrigues FCC, Bataglion C, Leite-Panissi CRA. Effectiveness of low-level laser therapy on pain intensity, pressure pain threshold, and SF-MPQ indexes of women with myofascial pain. Lasers Med Sci. 2017;32:419–28.
    1. Manfredini D, Favero L, Cocilovo F, Monici M, Guarda-Nardini L. A comparison trial between three treatment modalities for the management of myofascial pain of jaw muscles: a preliminary study. Taylor & Francis [Internet]. 2017. [cited 2022 Jun 6];36:327–31. Available at: .
    1. Borges RMM, Cardoso DS, Flores BC, et al. . Effects of different photobiomodulation dosimetries on temporomandibular dysfunction: a randomized, double-blind, placebo-controlled clinical trial. Lasers Med Sci. 2018;33:1859–66.
    1. Magri LV, Carvalho VA, Rodrigues FCC, Bataglion C, Leite-Panissi CRA. Non-specific effects and clusters of women with painful TMD responders and non-responders to LLLT: double-blind randomized clinical trial. Lasers Med Sci. 2018;33:385–92.
    1. Sobral A, Sobral S de S, Research GG, and S, 2020 Undefined. Phototherapy versus Occlusal Splint to control painful symptoms in Temporomandibular Disorder: controlled, randomized cost-effectiveness clinical trial. [Internet]. [cited 2022 Jun 6]. Available at: .
    1. Purgato M, Barbui C, Stroup S; Medicine CAP, 2015 Undefined. Pragmatic design in randomized controlled trials. [Internet]. 2018. [cited 2022 Jun 6]; Available at: .
    1. Yoong S, Wolfenden L, TCMJ of P, 2014 Undefined. Exploring the pragmatic and explanatory study design on outcomes of systematic reviews of public health interventions: a case study on obesity prevention trials. [Internet]. [cited 2022 Jun 6]; Available at: .

Source: PubMed

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