temporomandibular disorder
Conditions
Interventions
80 patients with chronic temporomandibular disorder (TMD) will be randomized and stealthily allocated in two treatment groups (experimental and control). Experimental group: 40 subjects will receive d
Drug
D26.660
V03.175.250.500.500
Sponsors
Faculdade de Odontologia de Bauru
Universidade de São Paulo
Faculdade de Odontologia de Bauru
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: age greater than 18 years, diagnosis of painful TMD, for example, masticatory myalgia, arthralgia of the temporomandibular joint and headache attributed to TMD diagnosed according to Diagnostic Criteria for Temporomandibular Disorder; presence of pain for at least 3 months
Exclusion criteria
Exclusion criteria: presence of uncontrolled systemic disorders, for example, diabetes, hypertension or endocrine disorders; presence of epilepsy, renal, hepatic and cardiac disorders; presence of neuropathies; pregnancy or lactation; intolerance to duloxetine or any component of the formulation; treatment for TMD in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of pain intensity in the period of 3 months, verified by means of the Visual Analogical Scale (VAS), from the observation of a variation of at least 30% in pain intensity in the measurements before and after treatment.;Increased pain inhibitory modulation in the 3 month period, verified by means of the Conditional Pain Modulation test, from the observation of a significant difference in the values obtained before and after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of sleep quality in the 3-month period, verified through the Pittsburgh Sleep Quality Index, based on a significant difference in the scores obtained before and after treatment.;Improvement of the psychosocial profile in the 3-month period, verified through a questionnaire measuring anxiety, depression, stress, catastrophic pain, somatization, chronic pain gradation and central sensitization, based on a significant difference in the scores obtained before and after treatment.;Improvement of the mechanical somatosensory profile in the period of 3 months, verified by quantitative sensory tests, from the finding of a significant difference in the values obtained before and after treatment. | — |
Countries
Brazil
Contacts
Public ContactDyna Mara Ferreira
Faculdade de Odontologia de Bauru
Outcome results
None listed