Effects of Mandibular Exercises Effect on Pain Perception and Sensitivity in Mandibular Myofascial Pain
2017年11月7日 更新者：Juan Fernando Oyarzo、Universidad Nacional Andres Bello
Effects of Mandibular Exercises Effect in Pain Perception and Sensitivity in Women With Myofascial Pain, a Double Blind Randomized Clinical Trial.
The effectiveness of mandibular exercises as a treatment of muscular Orofacial Pain is yet unknown.
This study hypothesized that training exercises can be an effective therapy improving pain perception.
研究概览
地位
完全的
条件
详细说明
Temporomandibular disorders (TMDs) represent heterogeneous musculoskeletal disorders, where most common presentation is mandibular muscle pain, which is also more common among female than men. Many interventions have been proposed for this pain control, regarding drugs, oral splints, relaxing exercises and self awareness but little is known about mandibular active contraction exercises. The aim of this study is to evaluate the effects of mandibular exercises in pain perception and sensitivity in women. A double blind randomized clinical trial will be conducted among fertile university student women with Oral Contraceptives (OC) use -to control hormonal influences-, with report of facial pain and myofascial pain diagnosis (RDC/TMD). They will be assessed in Visual analogue scale (VAS), sleep quality, Pressure Pain Threshold (PPT) and pressure pain tolerance (PPTol), and then allocated in one of the three interventions for 21 days: isometric mandibular active exercises over silicone bars; video-guided isotonic mandibular contractions over cloth pegs or counseling about disorders nature as passive comparison. After 21 days, VAS, PPT and PPTol in bilateral temporalis and masseter muscles will be assessed for a second time,) and compared with initial pain status.
Data will be entered by single blind operator, and will be open for quality auditing. Site monitoring will be performed by the University clinical entities.
Data checks will be also performed as planned. Descriptive and analytical statistics will be performed to address the primary and secondary objectives.
研究类型
介入性
注册 (实际的)
45
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 26年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Temporomandibular Myofascial pain diagnosis
- Oral contraceptives consumption
- Facial pain for at least 3 months (and at least 10 of the last 30 days at Visit 0)
- Agrees to terms for continuing/discontinuing certain prescription/over-the-counter pain medications.
Exclusion Criteria:
- Other orofacial pain diagnosis
- Oral surgery within 6 months
- Treatment for pain management within past 30 days
- Neurological or psychiatric disorders
- Orthodontic treatment
- History of pregnancy, pregnancy or breastfeeding.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Isometric exercise Group
Group of participants which perform Isometric mandibular exercises, once a day, for 21 days
|
daily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars
|
|
有源比较器：Isotonic exercise Group
Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days
|
daily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors
|
|
安慰剂比较：Counseling Group
Group of participants which receive education brochure and no further interventions.
|
subjects included in this group get an education brochure about the disorder and receive no further interventions
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the weekly mean subjective pain index after 21 days of treatment
大体时间：Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
|
Weekly mean subjective pain computed as the arithmetic mean of daily pain subjective values (visual analog scale - VAS) in Visit 1and prior to each study visit.
Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") for the different muscular sites tested.
|
Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
|
|
Change in the weekly mean pressure pain threshold (PPT) after 21 days of treatment
大体时间：Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
|
Weekly mean pressure pain threshold is computed as the arithmetic mean of daily pressure pain threshold values for muscular sites in Visit 1and prior to each study visit.
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
|
Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
|
|
Change in the weekly mean pressure pain tolerance (PPTol) after 21 days of treatment
大体时间：Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
|
Weekly mean pressure pain tolerance is computed as the arithmetic mean of daily pressure pain tolerance values for muscular sites in Visit 1and prior to each study visit.
Plot is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied per anatomical muscle site.
|
Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in pressure pain threshold at temporalis muscle after 1 week of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
|
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
|
Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
|
|
Change in pressure pain threshold at temporalis muscle after 2 weeks of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 14) ( 7 days in between)
|
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
|
Visit 1 (study day 0) and Visit 2 (study day 14) ( 7 days in between)
|
|
Change in pressure pain threshold at temporalis muscle after 3 weeks of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 21) ( 7 days in between)
|
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
|
Visit 1 (study day 0) and Visit 2 (study day 21) ( 7 days in between)
|
|
Change in pressure pain threshold at masseter muscle after 1 week of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
|
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
|
Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
|
|
Change in pressure pain threshold at masseter muscle after 2 weeks of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
|
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
|
Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
|
|
Change in pressure pain threshold at masseter muscle after 3 weeks of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
|
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of t masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
|
Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
|
|
Change in pressure pain tolerance at temporalis muscle after 1 week of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
|
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.
|
Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
|
|
Change in pressure pain tolerance at temporalis muscle after 2 weeks of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
|
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.
|
Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
|
|
Change in pressure pain tolerance at temporalis muscle after 3 weeks of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
|
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.
|
Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
|
|
Change in pressure pain tolerance at masseter muscle after 1 week of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
|
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.
|
Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
|
|
Change in pressure pain tolerance at masseter muscle after 2 weeks of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
|
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.
|
Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
|
|
Change in pressure pain tolerance at masseter muscle after 3 weeks of treatment
大体时间：Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
|
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.
|
Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
|
|
Change in the Pittsburgh Sleep Quality Index (PSQI) global score after 21 days of treatment
大体时间：Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
|
The PSQI has 19 items grouped into 7 component scores, each weighted equally on a 0-3 scale.
The 7 component scores are summed to obtain a global score, which has a range of 0-21.
|
Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Juan F Oyarzo, Prof、Universidad Andrés Bello
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年10月18日
初级完成 (实际的)
2016年12月6日
研究完成 (实际的)
2016年12月30日
研究注册日期
首次提交
2017年10月31日
首先提交符合 QC 标准的
2017年11月7日
首次发布 (实际的)
2017年11月13日
研究记录更新
最后更新发布 (实际的)
2017年11月13日
上次提交的符合 QC 标准的更新
2017年11月7日
最后验证
2017年11月1日
更多信息
与本研究相关的术语
其他研究编号
- PROPRGFO_2013/004
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
no plan
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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