Effects of TMD-specific Physiotherapy in Individuals With Hypermobile Ehlers-Danlos Syndrome
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Reduction of temporomandibular pain
研究概览
简要总结
The aim of this study is to analyze the effects of strictly defined physiotherapy in patients temporomandibular dysfunction (TMD) and hypermobile Ehlers-Danlos Syndrome (hEDS). Patients will be clinically examined before starting physiotherapy and fill in the questionnaires. Subsequently, it will be followed up whether changes occur as a result of physiotherapy.
This study is a pilot study and is intended to be hypothesis generating in nature. Based on the resulting hypothesis, it will be verified by a study with a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written consent to participate in the study
- •confirmed diagnosis of hEDS (based on the diagnostic criteria of the current classification of 2017).
- •pain in the area of the masticatory muscles and/or the temporomandibular joints
- •command of the German language, both spoken and written
排除标准
- •currently undergoing TMD-specific treatment (physiotherapy, pain therapy masticatory muscles and/or temporomandibular joint, orthopedic treatment, osteopathic treatment).
- •persons diagnosed with depression, anxiety or stress disorder
- •taking opiates
- •pregnant women
- •persons with mental disability
- •persons who are not able to speak and write the German language
- •persons with legal representatives
结局指标
主要结局
Reduction of temporomandibular pain
时间窗: Up to 3 months after the last physiotherapy intervention
The German version of the Graded chronic pain scale (GCS) is used to measure the level of pain. The score ranges from level 0-IV, 0 representing no pain, I-II functional pain, and level III-IV dysfunctional, chronic pain.
次要结局
- Effects on psychosocial impairment(Up to 3 months after the last physiotherapy intervention)
- Effects on oral health-related quality of life (OHRQoL)(Up to 3 months after the last physiotherapy intervention)