Estudo comparativo de terapias conservadoras para disfunção temporomandibular muscular crônica: ensaio clínico randomizado controlado cego

Abstract

The clinical trials in orofacial pain must include aspects of biopsychosocial involvement with broad domains related to quality of life, such as depression, catastrophism, somatization and sleep disorders, in order to generate standardizations between the profile of patients with temporomandibular disorders (TMD) and the outcomes measured with the treatments. Thus, as objective of this blind randomized controlled clinical trial, assessments of pain intensity reported by the patient, pain threshold to pressure, quality of life, sleep, and levels of depression were used to investigate the effects of conservative therapies, such as daily use of amitriptyline alone or associated with the stabilizing occlusal splint and weekly acupuncture in patients with chronic TMD within a period of four months. Ninety-six women aged 18-59 who met all eligibility criteria diagnosed by the Research Diagnostic Criteria for Temporomandibular Disfunction (RDC / TMD) for myofascial TMD (degree II or III) were randomized into four groups; and evaluated before and after four months of treatment. The treatment groups were: amitriptyline 10mg per day (n = 21); multimodal (amitriptyline 10mg per day and stabilizing occlusal splint) (n = 23); weekly sessions of acupuncture (n = 13). There was a control group that received no intervention (n = 21). The analyzed outcomes were: pain intensity reported by the participants, through visual analogue scale (VAS), pain threshold to pressure (PTP), using digital algometer, quality of life, depression and sleep quality, analyzed through validated questionnaires (OHIP-30, BDI and PSQI, respectively). Possible correlations between these parameters were investigated as well. The four groups were compared using statistical tests appropriate to the data distribution (α = 0.05). The Spearman correlation test was used to verify the correlations between observed changes in the deltas of all study variables. There was a significant reduction in pain intensity in the three intervention groups when compared to the control group. In the amitriptyline group, there was an increase in the PTP in masseter (p = 0.006), in temporal (p = 0.002); and temporomandibular joint (p = 0.001), in comparison to the other groups. The three groups presented significant and inverse correlations between pain intensity and PTP (p <0.05). The amitriptyline and multimodal groups had a significant reduction in the OHIP-30 score (p = 0.003, p <0.001, respectively), indicating an improvement in the quality of life within the four months. The improvement rate in quality of life experienced by the multimodal group was significantly higher when compared to the control and acupuncture groups (p = 0.009). Reduction of the general BDI scores occurred in all groups, being significant in the amitriptyline (p = 0.028) and multimodal (p <0.001) groups. The improvement in the degree of depression experienced by the multimodal group was significantly higher when compared to the group that did not receive intervention (p = 0.021). Amitriptyline and multimodal had significant improvement in sleep quality (p <0.001) compared to control (p <0.001). A direct and strong correlation (r = 0.6) was observed between quality of life and sleep in the amitriptyline group. It was concluded that the use of amitriptyline, multimodal therapy and weekly acupuncture were effective in reducing the intensity of pain reported by the patients. Amitriptyline alone and associated to the stabilizing occlusal splint increased PTP. The decrease in VAS was correlated with the increase in PTP in the investigated therapies. Amitriptyline and multimodal therapy were effective in improving quality of life, depression and sleep quality of the research subjects, while acupuncture has improved sleep quality. In amitriptyline therapy, improvement in sleep quality was correlated to the improvement in the quality of life of patients with chronic TMD.