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临床试验/NCT02991326
NCT02991326已完成不适用

Osteopathic Manipulative Treatment Effect in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints

Universidade Federal Fluminense1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年12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
入组人数
18
试验地点
1
主要终点
Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month

研究概览

简要总结

This study aim to contribute with the investigation of the therapeutic effect of osteopathic manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with temporomandibular disorder who make use of occlusal splints.

详细描述

Objective:

It is known the multifactorial etiology of Temporomandibular Disorders(TMD) which raises the need of a multidisciplinary approach for its treatment. Studies have presented good results about the use of occlusal splints along with other therapies. The Osteopathic Manipulative Treatment(OMT) has as characteristic the philosophy of global approach and precise functional diagnosis. Based on a lack of randomized blind trials about this subject, This study aim to contribute with the investigation of the therapeutic effect OMT in pain intensity and Quality of Life in participants diagnosed with TMD making use of occlusal splints.

Methodology:

This study is a randomized blind trial, with sample composed by 18 participants referred to the occlusion clinic of Fluminense Federal University (UFF), diagnosed by the team of dentists and interns of occlusion clinic through the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The participants will complete the Short Form 36 Health Survey(SF-36) to measure the quality of life, and pain intensity diagram with Numeric Rating Scale (NRS) to measure the pain intensity. The sample will be randomized into 2 groups (9 individuals for each): Test Group (TG) - patients subject to Clinical Treatment with splints (CT) offered at the Occlusion Clinic unit along with Osteopathic Manipulative Treatment - OMT. Control Group (CG) - patients subject only to CT and will receive a sham treatment that simulate the OMT to blind these participants. After the treatment, patients will be re-evaluated in 8 weeks' time.

Statistical analysis:

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •individuals who has diagnosis of Temporomandibular disorder.

排除标准

  • •individuals who already has subjected to osteopathic manipulative treatment to temporomandibular disorder.

研究组 & 干预措施

Test Group (TG)

Experimental

The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to Osteopathic Manipulative Treatment - OMT.

干预措施: Osteopathic Manipulative Treatment (Other)

Control Group (CG)

Sham Comparator

The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to sham intervention (Osteopathic Manipulative Treatment simulated).

干预措施: Sham intervention (Other)

结局指标

主要结局

Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month

时间窗: 2 months

The use of Numeric Rating Scale (NRS) to measure the pain intensity in each body area related by the individuals before and 2 months after the first intervention.

次要结局

  • Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months(2 months)
  • Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Saldanha Oliveira

Professor

Universidade Federal Fluminense

研究点 (1)

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