Efficacy of Duloxetine in Chronic facial pai
Not Applicable
- Conditions
- temporomandibular disorderC05.500.607.221.897.897C05.500.607.221.897
- Registration Number
- RBR-6pqx4n
- Lead Sponsor
- Faculdade de Odontologia de Bauru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.