ANS Effects of ULF-TENS Stimulation in Patients With and Without TMD
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Between groups difference in ANS activity, expressed as heart rate (HR), as assessed by computed polygraph
研究概览
简要总结
Using computerized pupillometry, previous research established that the autonomic nervous system (ANS) is dysregulated in patients who suffer from temporomandibular disorders (TMDs), suggesting a potential role for ANS dysfunction in pain modulation and the etiology of TMD. However, pain modulation hypotheses in TMD are still lacking.
The periaqueductal gray (PAG) is involved in the descending modulation of defensive behavior and pain through μ, κ, and δ opioid receptors. Transcutaneous electric nerve stimulation (TENS) has been extensively used for pain relief, as low-frequency stimulation is able to activate µ receptors. The aim of the present study is to use ANS polygraph and salivary/serum biomarkers to evaluate the effect of low-frequency TENS stimulation of ANS in TMD patients.
According to the Research Diagnostic Criteria for TMD, people with myogenous TMD and matched-controls will be enrolled. All subjects will be randomly assigned to control group (no tens stimulation) and case group (test stimulation); subsequently, ANS parameters by both biomarkers and ANS polygraph, before, soon after (end of stimulation), and late after (recovery period) sensorial TENS will be collected.
The overall statistics will be performed from all conditions recorded comparing controls vs cases.
The expected results consist in discovering ANS deregulation in TMD with and without TENS stimulation.
详细描述
Rationale & background information
Transcutaneous Electric Nervous Stimulation (TENS) is extensively used for pain relief. Notably, Ultra Low Frequency TENS (ULF-TENS) has been used both in research and in dentistry as a reliable tool for the diagnosis and treatment of temporomandibular disorders (TMD).
The mechanism of action of TENS has been widely investigated and involves local and systemic effects. In particular, experiments using animal models have shown systemic action trough involvement of the autonomic nervous system (ANS). Endogenous opioid and descending pain modulatory systems are thought to be involved in central activation during TENS stimulation. In particular, pain modulation occurs via endogenous opioids and affects the periaqueductal gray (PAG) and rostral ventromedial medulla (RVM) brain regions. The PAG provides a neuroanatomical and neuro-functional substrate to couple cortical outflow with the adequate autonomic response.
To study ANS activity and responses during conditions of rest and stress, heart rate variability (HRV) and breathing rate (BR) are traditionally used in experiments due to their repeatability and reliability. To study TENS effects on the autonomic nervous system, HRV has been used; however, pupillometry, skin conductance, blood flow and skin temperature, are also reliable indicators that have been used to study ANS.
Data supports the hypothesis that TENS could act on peripheral autonomic effectors via sympathovagal balance and PAG-opioid activity. Moreover, it has been suggested that PAG participates in the medial viscero-motor network that represents the link between emotional and cognitive functions managed by autonomic support. In particular, these neuro-connections is successfully investigated by the use of HRV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •myogenous TMD;
- •pain duration longer than 3 months;
- •presence of complete permanent dentition, with the possible exception of the third molars;
- •normal occlusion.
排除标准
- •Patients were excluded from the study if they met one or more of the following criteria:
- •presence of systemic or metabolic diseases;
- •eye diseases or visual defects;
- •history of local or general trauma;
- •neurological or psychiatric disorders;
- •muscular diseases;
- •cervical pain;
- •bruxism, as diagnosed by the presence of parafunctional facets and/or anamnesis of parafunctional tooth clenching and/or grinding;
- •pregnancy;
- •assumed use of anti-inflammatory, analgesic, anti-depressant, opioid, or myorelaxant drugs;
- •fixed or removable prostheses;
- •fixed restorations that affected the occlusal surfaces;
- •and either previous or concurrent orthodontic or orthognathic treatment.
- •For comparison with previous literature, the diagnosis of myofascial-type TMD was provided after clinical examination by a trained clinician according to group 1a and 1b of the Research Diagnostic Criteria for TMD (RDC/TMD), in a blinded manner
结局指标
主要结局
Between groups difference in ANS activity, expressed as heart rate (HR), as assessed by computed polygraph
时间窗: Average of 1 year
HR: heart rate assessed by ANS polygraph (expressed as beats/minute)
Between groups difference in ANS activity, expressed as heart rate variability parameters (HRV, DET, RR), as assessed by computed polygraph
时间窗: Average of 1 year
HRV: heart rate variability assessed by ANS polygraph (expressed as pure number); DET: determinism of HRV measurement assessed by KUBIOS software using HRV data (expressed as pure number); RR: recurrence rate assessed by KUBIOS software using HRV data (expressed as pure number).
Between groups difference in ANS activity, expressed as EMG of suprahyoid muscles, as assessed by computed polygraph
时间窗: Average of 1 year
EMG: surface electromyography of suprahyoid muscles (expressed in microvolts)
Between groups difference in ANS activity, expressed as breathing rate, as assessed by computed polygraph
时间窗: Average of 1 year
breathing rate: assessed by ANS polygraph (expressed as respiratory acts/minute);
Between groups difference in ANS activity, expressed as skin conductance, as assessed by computed polygraph
时间窗: Average of 1 year
Skin conductance: assessed by ANS polygraph (expressed in Ohm)
Between groups difference in ANS activity, expressed as skin temperature, as assessed by computed polygraph
时间窗: Average of 1 year
Skin temperature: assessed by ANS polygraph (expressed in grades Celsius).
次要结局
- Between groups difference in ANS activity, expressed as total antioxidant capacity (TAC), as assessed by ELISA(Average of 1 year)
- Between groups difference in ANS activity, expressed as serum total pro-oxidant activity (TPA) assessed by ELISA(Average of 1 year)
- Between groups difference in ANS activity, expressed as serum and salivary noradrenaline, as assessed by ELISA(Average of 1 year)
- Between groups difference in ANS activity, expressed as salivary alpha-amylase, assessed by ELISA.(Average of 1 year)
研究者
Davide Pietropaoli
Post Doc
University of L'Aquila