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临床试验/NCT03398499
NCT03398499已完成不适用

Physiotherapeutic Rehabilitation to Eliminate Temporomandibular Joint Pain in Patients After Orthognathic Surgeries

Pomeranian Medical University Szczecin0 个研究点目标入组 16 人开始时间: 2016年3月30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
16
主要终点
1. Change from baseline in Visual Analogic Scale

研究概览

简要总结

Orthognathic surgery procedures are often used to correct for skeletal II and III skeletal deformation, dental-facial-maxillary deformation, mandibular laterognathy and maxillofacial asymmetry. The factors that motivate patients to undergo this procedure are: improvement of chewing, speech and swallowing as well as aesthetic and psychosocial factors. Correction of occlusal-facial defects requires team orthodontic, surgical and rehabilitation treatment. As with any surgical procedure, various preoperative, intraoperative and postoperative com-plications may occur. Late complications that may occur in variously long periods of time from surgery include among others dysfunction of the temporomandibular joint, idiopathic atrophy of the condyloid muscles and associated pain. After orthognathic operations, pain occurs almost always, although the degree of its severity is a subjective sensation of each patient. Regardless of intensity, the fight against pain is one of the basic activities in post-operative care of the patient. The aim of the study was to evaluate the effectiveness of the physiotherapeutic method, which uses a slow-changing electromagnetic field and light ener-gy emitted from high-energy LEDs - light emitting diode, Magnetholedoterpy, in reducing pain in patients after orthognathic surgery Using the Viofor JPS device (Med & Live)

详细描述

BACKGROUND:

Patients with dental-facial deformity require orthognathic surgery to improve face profile and asymmetry, and to correct malocclusion. Positional changes in the mandible, jaw or both jaws during can affect the temporomandibular joint (TMJ), chewing muscles, surrounding soft tis-sue and symptoms of joint dysfunction (TMD). Pain is a natural response of the body to injury and at the same time one of the symptoms defining the inflammatory reaction. Orthognathic surgery procedures are often used to correct skeletal deformation II and III of the skeletal class, dental-facial-maxillary deformation, mandibular laterognathion and maximal-facial asymmetry. After-care care of the patient aims to minimize the risk of complications and therapy of existing ones. Regardless of intensity, the fight against pain is one of the basic activities in post-operative care of the patient. Some studies have shown that patients undergo-ing physiotherapeutic care immediately recover from the surgery much more quickly. The use of physical treatments allows to obtain a significant faster improvement in the pain and associated swelling after surgery.

PROBLEM:

The motivating factors for patients undergoing orthognathic surgery are: improvement of chewing, speech and swallowing as well as aesthetic and psychosocial factors. Correction of occlusal defects requires a group orthodontic, surgical and rehabilitation treatment. Surgical techniques that have evolved over the last decades now allow for almost any displacement within the bony structures of the jaw and mandible. The pain after orthogonal surgery occurs almost always, although the degree of its severity is the subjective sensation of each patient. Patients above all experience pain from mild to severe. His post-operative treatment is very important to reduce the stress caused the occurrence itself pain. Postoperative pain is often controlled by the use of opioids, which are often used in the United States. Cold compresses are also used in the stimulus treatment to reduce pain related associated with the occurrence of edema. Regardless of intensity, the fight against pain is one of the basic activities in post-operative care of the patient. Pharmacotherapy often necessary also causes a number of adverse effects harmful to the whole organism. In order to restore the physical and psychological comfort of patients after orthognathic procedures, physiotherapeutic methods as well as physiotherapeutic devices can be used.

AIM:

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
19 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 19-24 years, both male and female
  • Provide informed consent to participate in the study;
  • Having a diagnosis of TMJ pain (TMD) according to RDC/TMD
  • Visual analogic scale (VAS) score from 4 to 10 for 14 days
  • Not pregnant;
  • Not have contraindications to Extremely Low Frequency- Electro Magnetic Field(ELF EMF), such as implanted brain devices;
  • Not have history of alcohol or drugs abuse within the past 6 months as self-reported
  • Not have any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or se-vere migraines
  • Not have history of neurosurgery as self-reported
  • Not have history of major psychiatric disorders such as schizophrenia and bipolar disorder
  • Not have any other previously diagnosed disorder with symptoms similar to the TMD, such as fibromyalgia.

排除标准

  • One absence during therapeutic sessions;

研究组 & 干预措施

Magnetoledotherapy

Experimental

Active ELF EMF Participants will receive active transcranial low frequency elec-tromagnetic field and magnetic induction (ELF EMF) and high energy LED light were used stimulation,Using the Viofor JPS device (Med & Live)

干预措施: VIOFOR (Med & Life) (Device)

结局指标

主要结局

1. Change from baseline in Visual Analogic Scale

时间窗: 14 days

The visual analogic scale allows us to convert subjective sensations as pain on nu-merical data. A 10cm scale where 0cm is no pain and 10cm the worse imaginable pain, will be used and the subjects will be asked to mark a point on the scale repre-senting their pain. This instrument was used to compare VAS values on days 1, 5 and 10.

次要结局

未报告次要终点

研究者

发起方
Pomeranian Medical University Szczecin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward Kijak

Principal Investigator

Pomeranian Medical University Szczecin

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