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临床试验/NCT01832207
NCT01832207已完成不适用

Comparison Between Sensory and Motor Transcutaneous Electrical Nervous Stimulation on Electromyographic and Kinesiographic Activity of Patients With Temporomandibular Disorder: a Controlled Clinical Trial

University of L'Aquila0 个研究点目标入组 60 人开始时间: 2010年1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
入组人数
60
主要终点
sEMG values

研究概览

简要总结

Background The purpose of the present controlled clinical trial was to assess the effect of a single 60 min application of transcutaneous electrical nervous stimulation (TENS) at sensory stimulation threshold (STS), compared to the application of motor stimulation threshold (MTS) as well as to untreatment, on the surface electromyographic (sEMG) and kinesiographic activity of patients with temporomandibular disorder (TMD). Methods Sixty female subjects, selected according to the inclusion/exclusion criteria, suffering from unilateral TMD in remission were assigned to MTS, STS or untreatment. Pre- and post-treatment differences in the sEMG activity of temporalis anterior (TA), masseter (MM), digastric (DA) and sternocleidomastoid muscles (SCM), as well in the interocclusal distance (ID), within group were tested using the Wilcoxon test, while differences among groups were assessed by Kruskal-Wallis test; the level of significance was set at p ≤ 0.01.

研究设计

研究类型
Interventional
分配方式
Non 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 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age less than 30 years;
  • •female gender
  • •right-handed (7-10 points in Edinburgh inventory);
  • •presence of complete permanent dentition, with the exception of the third molars;
  • •normal occlusion;
  • •diagnosis of unilateral arthrogenous TMD on the Research Diagnostic Criteria for TMD (RDC/TMD), Axis I, groups II and III

排除标准

  • •having pacemaker or other electrical devices
  • •previous experience of TENS or biofeedback
  • •systemic diseases
  • •history of local or general trauma
  • •neurological or psychiatric disorders
  • •muscular diseases
  • •cervical pain
  • •bruxism diagnosed by the presence of parafunctional facets and/or anamnesis of parafunctional tooth clenching and/or grinding
  • •pregnancy
  • •assumption of anti-inflammatory, analgesic, antidepressant or myorelaxant drugs
  • •fixed or removable prostheses
  • •fixed restorations that affected the occlusal surfaces
  • •previous or concurrent orthodontic or orthognathic treatment

研究组 & 干预措施

STS

Active Comparator

Sensorial threshold of stimulation

干预措施: Transcutaneous electrical nerve stimulation (Device)

Placebo

Sham Comparator

干预措施: Placebo transcutaneous electrical nerve stimulation (Device)

MTS

Active Comparator

Motor threshold of stimulation

干预措施: Transcutaneous electrical nerve stimulation (Device)

结局指标

主要结局

sEMG values

时间窗: 60 min

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

Fabrizio Sgolastra

Dr

University of L'Aquila

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