Effects of Mandibular Exercises Effect in Pain Perception and Sensitivity in Women With Myofascial Pain, a Double Blind Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Change in the weekly mean subjective pain index after 21 days of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Isometric exercise Group
Group of participants which perform Isometric mandibular exercises, once a day, for 21 days
干预措施: Isometric mandibular exercises (Other)
Isotonic exercise Group
Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days
干预措施: Isotonic mandibular exercises (Other)
Counseling Group
Group of participants which receive education brochure and no further interventions.
干预措施: Counseling group (Behavioral)
结局指标
主要结局
Change in the weekly mean subjective pain index after 21 days of treatment
时间窗: 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.
Change in the weekly mean pressure pain threshold (PPT) after 21 days of treatment
时间窗: 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.
Change in the weekly mean pressure pain tolerance (PPTol) after 21 days of treatment
时间窗: 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.
次要结局
- Change in pressure pain threshold at temporalis muscle after 1 week of treatment(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(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(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(Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between))
- Change in the Pittsburgh Sleep Quality Index (PSQI) global score after 21 days of treatment(Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days))
- Change in pressure pain threshold at masseter muscle after 2 weeks of treatment(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(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(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(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(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(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(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(Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between))
研究者
Juan Fernando Oyarzo
Orofacial Pain & TMD Professor
Universidad Nacional Andres Bello