Morphological Changes in Asymptomatic Perimandibular Muscles After Dry Needling Assessed With Rehabilitative Ultrasound Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- mean of sternocleidomastoid muscle thickness
研究概览
简要总结
The articular disc of temporomandibular joint and three muscles of the cervico-facial region (temporal, masseter, sternocleidomastoid) are evaluated by means of sonographic images to observe and measure their dimensions' changes after a dry needling intervention. The participants are asymptomatic subjects and will be randomly divided in 2 groups: half of them are treated on the right side of the face, while the other half on the left side. Our hypothesis is that ultrasonography can reveal changes in the structures measured on the treated side.
详细描述
The trial is designed as a before-and-after study conducted on asymptomatic subjects. The aim is to assess temporomandibular joint and three perimandibular muscles (temporal, masseter, sternocleidomastoid) by means of rehabilitative ultrasound imaging, carried out by a novice clinician. These evaluations are performed before and after a dry needling treatment directed to the tree studied muscles of one side of the face. The side to be treated is randomly assigned by using a computer-generated randomization process, the other side is used as control.
One month after the treatment sonographic images are taken by the novice clinician and by an expert one. The aim is to assess the reliability of ultrasonography comparing the results of their assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age major then 18 years
- •Must be asymptomatic in the face/head region at the time of the visit and in the previous 6 months.
排除标准
- •Pregnancy
- •medical history of systemic disease
- •current pharmacological therapy
- •history of recurrent headache and/or neck pain
- •presence of orofacial pain or temporomandibular symptoms assessed with the DC/TMD (Diagnostic Criteria for TemporoMandibular Disorders)
- •current use of a bite during sleep
结局指标
主要结局
mean of sternocleidomastoid muscle thickness
时间窗: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the superficial and the deep border of the muscle (cm)
mean of temporal muscle thickness
时间窗: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the opposing borders of the muscle, along the transverse axis of the muscle (cm)
mean of sternocleidomastoid muscle cross-sectional area
时间窗: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the area of the muscle in transversal plan measured after drawing the outline of the muscle in an image obtained with the panoramic view function (cm2)
mean of masseter muscle width
时间窗: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the opposing extremities of the muscle along the transverse axis of the muscle (cm)
mean of masseter muscle cross-sectional area
时间窗: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the area of the muscle in transversal plan measured after drawing the outline of the muscle in an image obtained with the panoramic view function (cm2)
mean of temporomandibular joint disc thickness
时间窗: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the opposing surfaces of the disc (cm)
mean of masseter muscle thickness
时间窗: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the superficial and the deep border of the muscle (cm)
mean of sternocleidomastoid muscle width
时间窗: Baseline (before the treatment), immediately after the treatment, one month after the treatment
the distance between the opposing extremities of the muscle along the transverse axis of the muscle (cm)
次要结局
- mean of maximum mouth opening(Baseline (before the treatment), one month after the treatment)
研究者
Alice Botticchio
Principal investigator
Poliambulatorio Physio Power