Effectiveness of the Use of Antidepressants in the Treatment of Muscle Type Temporomandibular Disorders
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The aim of this study is evaluate the effectiveness of the use of antidepressants in the treatment of muscle type temporomandibular disorders, with a sample of 60 to 80 participants.
详细描述
Temporomandibular Disorders (TMDs) involve alterations of the temporomandibular joint (TMJ), masticatory muscles, and related structures.
Epidemiologic data indicates that 33% of the general population has at least one symptom of a temporomandibular disorder (TMD) and 6% to 7% have TMDs severe enough to seek specific treatment.
The etiology of pain and disability in myofascial pain is understood via a bio- psychosocial model reflecting a complex interaction between physical, behavioral, social, and psychological factors. In turn, the treatment of myofascial pain is often multimodal.
Ongoing pain may be associated with co-morbid conditions such as anxiety, depression and sleeplessness. It is important to recognize and treat emotional distress as well as physical symptoms. Chronic pain and depression seem to share common neurochemical substrata and perhaps even similar dysfunctional alterations.
Chronic syndromes such as bruxism and TMD are commonly associated with depression. Research Investigator reported that 39% of patients with TMD are moderately to severely depressed and 55% have moderate to severe somatization symptoms. A cross-cultural study by List and Dworkin supported these findings, showing that 45% of Swedish patients and 51% of American patients who met the diagnostic criteria for TMD also suffered from moderate to severe depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated at the Centro Hospitalar e Universitário de Coimbra (CHUC);
- •Patients who, according to the diagnostic Criteria for Temporomandibular disorder (DC/TMD) , present Myofascial pain in the masticatory muscles for more than 6 months;
- •Adult patients
排除标准
- •Under 18 years old;
- •Pregnants,
- •Patients who have related adverse effects to the citalopram and/or amitriptyline;
- •Patients presenting severe diseases like coronary pathology, renal insufficiency, active cancer, respiratory insufficiency;
- •Patients who have been treated to myofascial pain before
研究组 & 干预措施
Citalopram
Citalopram 10mg
干预措施: Citalopram 10 MG (Drug)
Amitriptyline
Amitritptyline 25 mg
干预措施: Amitriptyline (Drug)
Bite Splint
Michigan Splint, nocturnal use
干预措施: Bite Splint (Device)
结局指标
主要结局
Pain intensity
时间窗: 9 weeks
Pain intensity according to a visual analogue scale from 0 to 10.
次要结局
未报告次要终点
研究者
Bruno Macedo de Sousa
Principal Investigator
University of Coimbra
