跳至主要内容
临床试验/NCT02152267
NCT02152267已完成不适用

ANALGESIC EFFECT OF CATHODAL TRANSCRANIAL CURRENT STIMULATION OVER RIGHT DORSOLATERAL PREFRONTAL CORTEX IN SUBJECTS WITH MUSCULAR TEMPOROMANDIBULAR DISORDERS: A Double Blind Crossover Randomized Clinical Trial

Federal University of Bahia1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Change from baseline in Visual Analogic Scale

研究概览

简要总结

  1. BACKGROUND: Temporomandibular Disorders (TMD) have become part of the daily routine of all the health care professionals. Some studies have shown improvement in subjects with chronic pain using neuromodulation. Chronic pain is involved with neuronal excitability and the excitatory modulation is also being studied to treat chronic pain. Transcranial direct current stimulation (tDCS) allows the neuronal membranes to be neuromodulated. tDCS can enhance or inhibit the potential actions on the cortex. Studies with animals has shown that anodal stimulation modulate the membrane in the way to depolarize which results in a long term potential in the stimulated area.
  2. PROBLEM: Most strategies for the treatment of TMDs are local and aim to treat directly the cranial-facial muscles, applying kinesitherapy on Temporomandibular joint (TMJ) and/or on the jaws and on the occlusion of teeth. Some drugs, such as tricyclic antidepressants, that act in the CNS are used in these patients with positive results in the beginning of the treatment. However, many patients after using these drugs in a daily basis, are refractory to them and do not present an improvement in the pain anymore or present several side-effects. Therefore, the investigators want to know if tDCS over dorsolateral prefrontal cortex (DLPFC) would have an analgesic effect when reaching emotional areas.
  3. HYPOTHESIS: The investigators believe that neuromodulation by tDCS over DLPFC would decrease the anxiety level and consequently the muscular hyperactivity that is an important etiological factor of TMD. For that, the masseter motor evoked potential (MEP) will be used to verify any change.
  4. AIM: To investigate if cathodal tDCS over right DLPFC has analgesic effects in subjects with muscular TMD.
  5. METHOD: The investigators will run a three-arm crossover double blind with 15 muscular TMD subjects. The group treatments will be cathodal tDCS 1mA, cathodal tDCS 2mA and Placebo. To verify selection criteria the investigators will use RDC/TMD, Visual analogical scale (VAS) score from 4 to 10 for six months or longer, Inventory of state-trit anxiety (ISTA) score more than 42. The outcomes will be VAS, sensory testing, Electroencephalogram (EEG) and ISTA.

详细描述

  1. INTRODUCTION Pain is among the main complaints of most patients that seek care in a hospital or a primary care unit. Temporomandibular Disorders (TMD) patients have become part of the daily routine of all the health care professionals. Temporomandibular and cranial-facial disorders are so prevalent that, since 1987, the International Headache Society holds meetings to classify different types of pain associated with head. This resulted in the publication of the Manual of Classification of Headaches - The International Classification of Disorders Headache was revised in 2013.

There are different strategies to treat TMD patients, and the best is chosen depending on the type of problem diagnosed or the most suitable strategy according to professional experience. Strategies range from advice on lifestyle, psychotherapy, containment of the jaw, kinesitherapy, ultrasound, TENS, muscle relaxants plates, allopathic and homeopathic therapies and surgical interventions to the temporomandibular joint (TMJ). Some of these techniques aim to treat the muscles, others treat the dental occlusion or joint structures and there are those whose primary focus is the psycho-emotional factors. As The TMDs are due to various factors of muscular, joint, emotional, inflammatory, autoimmune or even infectious reasons, the treatment should include different therapies during the rehabilitation process, considering the best strategies for each patient. Literature has shown that the causes of muscular origin are more prevalent in patients with this type of disorder). A systematic review using studies with functional brain imaging, showed that, although the majority of disorders are associated with muscle pain, this would be secondary to a process triggered by the Central Nervous System (CNS). Following this theory, some behavioral studies have shown that the TMD, almost always, are related to preexisting psychopathology.

Chronic pain is involved with neuronal excitability. a study using transcranial magnetic stimulation (TMS) found higher threshold in both sides of resting motor cortex with lower up regulation responses. Furthermore they found lower responses in the intracortical facilitation and inhibition.

The transcranial direct current stimulation (tDCS) allows the neuronal membranes to neuromodulate and it can enhance or inhibit the potential actions on the cortex. Studies with animals has shown that anodal stimulation modulate the membrane in the way to depolarize which results in a long term potential in the stimulated area. Some studies have shown improvement in subjects with fibromyalgia and chronic pain using neuromodulation . Some authors suggest anodal tDCS over motor cortex to decrease pain while modulating the activity in the neuronal networks responsible for pain, an example of that is the thalamus. It also facilitates the descending inhibition of pain. However few evidences support the efficacy of tDCS.

Another montage is tDCS over dorsolateral prefrontal cortex (DLPFC). This area is involved with anxiety and depression without direct analgesic effect. A study showed a pain level decrease after tDCS over DLPFC in patients with emotional and affective troubles. The authors suggested it based on emotional modulation by pain independent networks by somatosensory pain perception. A study found anxiety modulation after tDCS application over DLPFC using cathodal current on the right side and anodal on the left side. This result is just a weak evidence that the tDCS anxiety effect, there is a demand to investigate that approach.

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, Outcomes Assessor)

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
  • •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
  • •Inventory of state-trit anxiety (ISTA) score more than 42

排除标准

  • •Pregnancy;
  • •Contraindications to tDCS:
  • •metal implants
  • •implanted brain devices
  • •History of alcohol or drugs abuse within the past 6 months as self-reported
  • •Use of carbamazepine within the past 6 months as self reported
  • •Any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines
  • •History of neurosurgery as self-reported
  • •History of joint problems as disc displacement, arthralgia, osteoarthritis and osteoarthritis (Axis I, II and III diagnosis)
  • •History of major psychiatric disorders such as schizophrenia and bipolar disorder
  • •Any other previously diagnosed disorder with symptoms similar to the DTM, such as fibromyalgia.

研究组 & 干预措施

tDCS 1mA

Experimental

the parameters used in the TDCS will be 1mA, cathodal over right DLPFC and anodal over supraorbital contralateral area.

干预措施: tDCS (Device)

tDCS 2mA

Experimental

the parameters used in the TDCS will be 2mA, cathodal over right DLPFC and anodal over supraorbital contralateral area.

干预措施: tDCS (Device)

tDCS Sham

Sham Comparator

the parameters used in the TDCS will be sham, cathodal over right DLPFC and anodal over supraorbital contralateral area.

干预措施: tDCS (Device)

结局指标

主要结局

Change from baseline in Visual Analogic Scale

时间窗: 4 weeks

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 by the subjects everyday during one week in a pain diary. A weekly response average will be calculated before the first interventions and after each one. Subjects will also fill a VAS before and after each tDCS session. The averages will be used to compare the VAS values before and after each intervention.

次要结局

  • Change from baseline in Electroencephalogram (EEG)(4 weeks)

研究者

发起方
Federal University of Bahia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eduardo Pondé de Sena

Associate Professor of Pharmacology Institute of Health Sciences Federal University of Bahia and Permanent Professor at Postgraduate Program in Interactive Processes of Organs and Systems of the Health and Science Institute of Federal University of Bahia

Federal University of Bahia

研究点 (1)

Loading locations...

相似试验