Effectiveness Specific Manual Therapy in a Multimodal Physical Therapy Treatment in Patients With Tinnitus and Temporomandibular Joint Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline Intensity of Temporomandibular Joint pain.
研究概览
简要总结
Tinnitus is one of the most prevalent symptoms that causes more disability in patients with temporomandibular disorder (TMD). The present study postulates a possible link between temporomandibular joint (TMJ) and inner ear based on their anatomical, biomechanical and physiological relationship, proposing a physiotherapy treatment for the temporomandibular joint to improve tinnitus. The aim of the study is to evaluate the effectiveness of adding specific manual therapy to a multimodal physiotherapy treatment in patients with tinnitus and temporomandibular disorder.
详细描述
-
- INTRODUCTION
Tinnitus is one of the most prevalent symptoms that causes more disability in patients with temporomandibular disorder (TMD).
According to various studies, the incidence varies between 19-69%, with a 2:1 ratio between women and men, being higher in Western industrialized countries. Frequent conjunction between TMJ problems and tinnitus has led to propose the existence of a link between these two clinical entities. However, the mechanism linking TMD and this otologic symptom is unknown.
The present study postulates an association based on the anatomical relationship between the TMJ and the inner ear. The ligaments of the inner ear bones are close to TMJ ligaments so the movements of the mandibular condyle may influence on them. The discomallear ligaments (DML) and the anterior mallear ligament (AML) can be considered as intrinsic ligaments of the TMJ.
TMJ blood supply depends on the tympanic and auricular arteries, and in its innervations are involved nerve branches of the masseter, lateral and temporal/ internal pterygoid, key muscles for the condylar movements (open and close the mouth and lateral movements).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 and ≤ 65 years old.
- •Suffering from tinnitus and temporomandibular dysfunction with a myofascial or joint dysfunction origin: diagnosis of tinnitus attributed to TMD
- •In a subacute and chronic phase.
排除标准
- •Non signature of the informed consent.
- •Patients with a diagnosis of ENT and / or neurological problems from which could arise tinnitus and / or the temporomandibular pain.
- •Inability to read, understand and complete questionnaires, read and understand a brochure, or understand and follow verbal commands (e.g. Illiteracy, dementia or blindness).
- •Having received physiotherapy in the last 12 months.
研究组 & 干预措施
Specific Manual Therapy Group
Conventional Physiotherapy and Specific manual therapy, six one hour treatment sessions. An hour for week.
干预措施: Specific Manual Therapy (Other)
Multimodal Group
Conventional Physiotherapy, six one hour treatment sessions. An hour for week.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Change from baseline Intensity of Temporomandibular Joint pain.
时间窗: At baseline, 1 week post-treatment, and 3 and 6 months post-treatment
Intensity of TMJ pain (measured by NPRS) at rest.
Change from baseline of tinnitus severity.
时间窗: At baseline, 1 week post-treatment, and 3 and 6 months post-treatment
Intensity of tinnitus (measured by VAS) at rest. It will be determined by assessing tinnitus annoyance and tinnitus loudness and the average will be recorded.
次要结局
- Change from baseline degree of tinnitus-related handicap(At baseline, 1 week post-treatment, and 3 and 6 months post-treatment)
- Change from baseline degree of disability caused by temporomandibular disorder(At baseline, 1 week post-treatment, and 3 and 6 months post-treatment)
- Change from baseline quality of life.(At baseline, 1 week post-treatment, and 3 and 6 months post-treatment)
- Change from baseline range of motion(At baseline, 1 week post-treatment, and 3 and 6 months post-treatment)
- Change from baseline emotional state (depressive symptoms)(At baseline, 1 week post-treatment, and 3 and 6 months post-treatment)
- Change from baseline pressure pain sensibility(At baseline, 1 week post-treatment, and 3 and 6 months post-treatment)
研究者
MARIA JOSE DIAZ ARRIBAS
Tenured University Professor
Universidad Complutense de Madrid