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Non-specific effects and clusters of women with painful TMD responders and non-responders to LLLT: double-blind randomized clinical trial

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Abstract

The aim was to analyze the non-specific effects (placebo, spontaneous remission, and regression to the mean) of the low-level laser therapy (LLLT) in women with myofascial pain (painful temporomandibular disorder (TMD)), as well as to differentiate between responders and non-responder clusters to active and placebo LLLT according to the anxiety levels, salivary cortisol, use of oral contraceptives, and premenstrual period. Sixty-four women diagnosed with myofascial pain (Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)) were included, divided into laser (n = 20), placebo group (n = 21), and 23 controls (without treatment (WT)). The LLLT applied was 780 nm, masseter and temporal = 5 J/cm2 (20 mW–0.5 W/cm2), and TMJ area = 7.5 J/cm2 (30 mW–0.8 W/cm2), eight sessions, twice a week. The pain intensity (visual analogue scale (VAS)), anxiety (Beck Anxiety Inventory), salivary cortisol, and menstrual cycle’s data at the baseline, T1–T8, and 30 days after LLLT (follow-up) were evaluated. The laser group showed 80% of pain reduction, placebo 85%, and WT 43% in T8. Women with severe anxiety and at the premenstrual period did not reduce pain with any LLLT. Active and placebo LLLT had similar effectiveness during the treatment period; however, women with moderate anxiety, cortisol levels above 10 ng/ml, and without contraceptive use maintain analgesia longer with active LLLT than placebo (follow-up 30 days). Women with low levels of anxiety, salivary cortisol below 10 ng/ml, and with contraceptive use showed the higher pain reduction. The analgesia promoted by LLLT in women with myofascial pain is a result of non-specific effects during the treatment period, although active LLLT is more effective in maintaining the analgesia after treatment (30 days) for the cluster of women with moderate anxiety, salivary cortisol above 10 ng/ml, and without contraceptive use.

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Acknowledgments

This study was financially supported by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) and Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq).

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Correspondence to Christie Ramos Andrade Leite-Panissi.

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All procedures were performed in accordance with the guidelines of the Brazilian Ethics Committee on Human Research. This study was conducted after approval by the Ethics Committee of the School of Dentistry of Ribeirão Preto (under protocol 33658114.7.0000.5419). All subjects were informed about the study and signed a consent form. Patients who composed the placebo group and did not have pain reduction after the study completion were invited to receive treatment with LLLT, in the same parameters of the active laser group.

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The authors declare that they have no conflict of interest.

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Magri, L.V., Carvalho, V.A., Rodrigues, F.C.C. et al. Non-specific effects and clusters of women with painful TMD responders and non-responders to LLLT: double-blind randomized clinical trial. Lasers Med Sci 33, 385–392 (2018). https://doi.org/10.1007/s10103-017-2406-4

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  • DOI: https://doi.org/10.1007/s10103-017-2406-4

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