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临床试验/NCT04977349
NCT04977349已完成不适用

Manual Therapy Effectivity Combinated or Lonely With an Exercises Program for a Wind Musicians With Orofacial Pain

Prof. Dr. Daniel Pecos Martín4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9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
发起方
入组人数
40
试验地点
4
主要终点
Orofacial pain

研究概览

简要总结

Orofacial pain is one of the most common dysfunctions among wind musicians, a population with a high incidence of temporomandibular disorder (TMD). Regarding the treatment of TMD, the efficacy of manual therapy and therapeutic exercise has been studied, but there is a lack of high quality research supporting its implementation. There is, however, an agreement on the need of combining the treatment of the temporomandibular joint and the cervical spine, due to their close biomechanical relation.

Aims of the study: To analyse the efficacy of an evidence-based manual therapy protocol alone or in combination with an exercise program on the treatment of orofacial pain during musical practice on wind musicians. Furthermore, this study aims at observing whether if said treatment is more effective in the short, medium, or long term, and which variables are the most influenced.

详细描述

Methods: A sample of 40 wind musicians with orofacial pain during practice with the instrument will be recruited in the different conservatories of the Community of Madrid. The sample will be divided into two different groups: a control group who will receive the manual therapy protocol, and an experimental group who will, in addition, receive an exercise program. Treatment will consist of ten session distributed along 5 weeks, of an approximated duration of 30 minutes per session. Assessments will be carried out pre- and post-intervention, and for a two- and four-months follow-up.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Metal or wood wind musicians
  • Orofacial pain during the practice in the last 30 days.
  • More than 20 hours by week in the practice.
  • Between 18-65 years old.

排除标准

  • Neurological diseases.
  • Analgesics previous treatments.
  • Any trauma or bone fractures in skull or cervical spine.
  • Any surgical intervention in cervical spine, orofacial region or temporo-mandibular joint.

研究组 & 干预措施

Wind Musicians

Experimental

Isometric exercises for: cranial protrusion, mouth opening, laterality cervical movement and cervical coordination by laser assesment. And the manual therapy from the Active Comparator group.

干预措施: Manual Therapy (Other)

Wind Musicians

Experimental

Isometric exercises for: cranial protrusion, mouth opening, laterality cervical movement and cervical coordination by laser assesment. And the manual therapy from the Active Comparator group.

干预措施: Exercise program (Other)

Wind musicians

Active Comparator

This group will be treated by manual therapy: suboccipital inhibition, myofascial extracavitary treatment in (superior trapezius fibers, Sternocleidomastoid (ECOM), masseter and temporalis) and intracavitary muscles (medialis and lateral pterygoid muscles).

干预措施: Manual Therapy (Other)

Wind musicians

Active Comparator

This group will be treated by manual therapy: suboccipital inhibition, myofascial extracavitary treatment in (superior trapezius fibers, Sternocleidomastoid (ECOM), masseter and temporalis) and intracavitary muscles (medialis and lateral pterygoid muscles).

干预措施: Exercise program (Other)

结局指标

主要结局

Orofacial pain

时间窗: Change from baseline at 2 months

Visual Analogic Scale.The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured from 0 (no pain) to 10 (maximum pain). All the subjects will showed their pain level.

Pressure Pain Threshold

时间窗: Change from baseline at 2 months

An algometer Wagner FPI 10-WA will be used to determine the Pressure Pain Threshold in trigger points.

Range of Temporo mandibular Movement

时间窗: Change from baseline at 2 months

A vernier caliper will be used to measure mandibular movements. A vernier caliper is a validated tool to measure the opening, protusion, laterotrusion and overjet movements of the temporo mandibular joint

cervical range of movement (CROM)

时间窗: Change from baseline at 2 months

The instruments used to assess CROM will be a CROM goniometer. The CROM goniometer is a validated tool to measure the flexion, extension, rotation and tilt movements of the cervical spine.

次要结局

未报告次要终点

研究者

发起方
Prof. Dr. Daniel Pecos Martín
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Daniel Pecos Martín

Vice-dean of Physiotherapy

University of Alcala

研究点 (4)

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