NCT03285685Unknown2 期
Effect of Noninvasive Neuromodulation on Chronic Pain and Anxiety Levels in Individuals With Temporomandibular Disorders
Federal University of Paraíba1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年10月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline in Visual Analogic Scale
研究概览
简要总结
- BACKGROUND: Temporomandibular Dysfunction (TMD) is a disease characterized by a set of signs and symptoms that may include joint noise, pain in the mastication muscles, limitation of mandibular movements, facial pain, joint pain and / or dental wear. Pain appears as a very present and striking symptom, with a tendency to chronicity. This is a difficult treatment condition often associated with psychological factors such as anxiety. Chronic pain involved modifications in the neuronal excitability, therefore, the neuromodulation withTranscranial direct current stimulation (tDCS) appears as a possible strategy for the treatment. Some studies have shown improvement in subjects with chronic pain using tDCS, however, it needs further investigation of its therapeutic effect.
- PROBLEM: Despite the wide range of strategies used to treat patients with TMD, some patients have a temporary and / or unsatisfactory relief response, which generates hypotheses that emotional components often underlie treatment refractoriness, and development of a memory for pain. Thus, it is evident the need for a therapy that acts directly on the central nervous system (CNS). This action can occur through medications, however, many individuals are refractory or have side effects such as dependence and / or tolerance. In this way, the importance of new treatments involving neuromodulation and neuroplasticity mechanisms, such as tDCS, is highlighted, which may become a complementary alternative to the different types of treatment already in use. Besides corroborating with the need to give preference to reversible and non-invasive procedures.
- HYPOTHESIS: The investigators believe that the use of anodic tDCS in the treatment of patients with TMD presenting with chronic pain will have a positive effect, promoting a decrease in painful symptoms through a Central Nervous System (neuromodulation) action in comparison to placebo stimulation. Because of the mutual influence between pain and psychological factors, it is expected that the analgesic effect will have a positive effect on anxiety levels. In addition, it is believed that a more intense analgesic effect occurs in the DLPF stimulation group of the cortex compared to the M1 stimulation group, since this region demonstrates to be responsible for the processing of the emotional component of the pain, often underlying the refractoriness to treatment
- AIM: To evaluate and compare the efficacy of anodic tDCS, applied in different cortical regions (M1 and DLPFC), in the pain and anxiety levels in individuals with chronic pain due muscular TMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-60 years, both male and female
- •Provide informed consent to participate in the study;
- •Having a diagnosis of muscular pain DTM according to IA and IB, axis I RDC/TMD
- •Visual analogic scale (VAS) score from 4 to 10 for six months or longer
- •Presence of moderate depressive symptoms through SCL-90 scale evaluation of Axis II, (RDC / TMD)
- •Not pregnant;
- •Not have contraindications to tDCS, such as metal implants on the head or implanted brain devices;
- •Not have history of alcohol or drugs abuse within the past 6 months as self-reported
- •Not use of carbamazepine within the past 6 months as self reported
- •Not have any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines
- •Not have history of neurosurgery as self-reported
- •Not have history of major psychiatric disorders such as schizophrenia and bipolar disorder
- •Not have any other previously diagnosed disorder with symptoms similar to the DTM, such as fibromyalgia.
排除标准
- •Two absences during treatment sessions;
- •During the research, go against some criteria of inclusion mentioned above, as in the case of women, getting pregnant.
研究组 & 干预措施
tDCS M1
Experimental
active tDCS Participants will receive active transcranial direct current stimulation.
干预措施: active tDCS (Device)
tDCS DLPF
Experimental
active tDCS Participants will receive active transcranial direct current stimulation.
干预措施: active tDCS (Device)
tDCS sham
Sham Comparator
tDCS Sham Participants will receive sham transcranial direct current stimulation.
干预措施: sham tDCS (Device)
结局指标
主要结局
Change from baseline in Visual Analogic Scale
时间窗: 4 months
The visual analogic scale allows us to convert subjective sensations as pain on numerical data. A 10cm scale where 0cm is no pain and 10cm the worse imaginable pain, will be used and the subjects will be asked to mark a point on the scale representing their pain. This instrument will be used to compare the VAS values before and after the intervention.
次要结局
- Patient Global Impression of Change Scale (PGICS)(4 months)
- State-Trait Anxiety Inventory(4 months)
研究者
Tatyanne dos Santos Falcão Silva
Tatyanne Falcão
Federal University of Paraíba
研究点 (1)
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