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临床试验/NCT04777838
NCT04777838Unknown2 期

Effectiveness of the Use of Antidepressants in the Treatment of Muscle Type Temporomandibular Disorders

University of Coimbra1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Citalopram 10mg

干预措施: Citalopram 10 MG (Drug)

Amitriptyline

Active Comparator

Amitritptyline 25 mg

干预措施: Amitriptyline (Drug)

Bite Splint

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Macedo de Sousa

Principal Investigator

University of Coimbra

研究点 (1)

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