Effects of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Orofacial Pain Unresponsive to Conventional Treatment. A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline in Visual Analogue Scale (VAS) for pain
研究概览
简要总结
Patients affected by chronic orofacial pain represent an emergent medical problem due to the lack of knowledge on the cause, pathophysiology and psychology of many of these conditions, that belongs to a multifactorial origin.
Particularly, temporomandibular joint disorders involve a series of symptoms that refers both to intrinsic and extrinsic joint conditions where pain can be associated to a reduction of the joint movement, click or to other sounds of the joint.
The lack of a recognized causal therapy led to the suggestion of many treatment modalities with a multidisciplinary approach for the management of symptoms that include the use of occlusal splints, physiotherapy-speech therapy, behavioral and physical therapy, drugs, chirurgical approaches. In most cases these strategies together allow the control of the symptoms, even though they aren't completely resolutive.
In these patients is frequent chronic pain and ineffectiveness of common drugs used.
It has been demonstrated how transcranial electrical brain stimulation with direct current (tDCS) is able to reduce the intensity and the duration of chronic pain.
Stimulating the motor cortex can reduce pain by modulating brain activities in the areas involved in cerebral circuits controlling pain, such as thalamus, facilitating the descendant inhibitory mechanisms and enhancing the number of opiates receptors.
This clinical trial is based on the evaluation of the effects of tDCS on pain and on activities daily living (ADL) participation patients with chronic orofacial pain that don't respond to other treatments.
详细描述
Inclusion criteria:
- Male and female between 18 and 75 years old
- Clinic history of previous orofacial and/or dental surgery
- Chronic orofacial pain for more than a year measurable by the VAS more than 3 .
- Pain not responsive to pharmacological treatment (analgesic, anti inflammatory, opiaces, antidepressant drugs and physiotherapy modalities)
Outcome measures:
Subjects will be assessed before the beginning of the treatment (T0), after tDCS (T1) and after one month of stimulation(T2) .
In the two weeks prior to T0 the patient will be asked in a questionnaire to report daily the level of pain, anxiety and state of mind using the VAS. This period of observation is necessary for the patient to get used to these measures and to underline possible intra-subject changing.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female between 18 and 75 years old
- •Clinic history of previous orofacial and/or dental surgery
- •Chronic orofacial pain for more than a year measurable by the VAS more than 3 .
- •Pain not responsive to pharmacological treatment (analgesic, anti inflammatory, opiates, antidepressant drugs and physiotherapy modalities)
排除标准
- •Contraindication to tDCS: presence of metallic implants that can be stimulated, moved or overheated by electric current, positive anamnesis for epilepsy, implantable systems ( ventriculoperitoneal shunt, pacemaker, intracranial pumps, intracranial metallic systems)
- •Major neurological or psychiatric pathologies
- •Pregnancy
- •Severe hepatorenal and cardiopulmonary diseases
结局指标
主要结局
Change from baseline in Visual Analogue Scale (VAS) for pain
时间窗: 1) one day pre-tDCS 5 days treatment. 2) Every day, for 5 days pre and post tDCS stimulation. 3) one day post tDCS 5 days treatment. 4)Follow up at one month.
Visual analogue scale measure for pain. Score range from 0-10. For rating overall pain: mild = 1-3, moderate = 4-7, severe = 8-10 For rating Chronic Pain, excellent internal consistency for a single pair of rating between Numeric Pain Rating Scale and Visual Analogue Scale (r = 0.86)
次要结局
- Research Diagnostic Criteria Temporomandibular disorders (RDC/TMD) AXIS I(1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up)
- Research Diagnostic Criteria Temporomandibular disorders RDC/TMD AXIS II(1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up)
- Symptoms Checklist 90-R scales (SCL 90-R)(1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up)
- Electrical and pressure pain threshold(1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up)
- Oral Health Impact Profile 49 (OHIP 49)(1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up)
- Pain detect Questionnaire (PD-Q)(1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up)
研究者
Sofia Straudi, MD
MD
University Hospital of Ferrara