Physiotherapeutic Rehabilitation in Patients After Orthognathic Surgery

January 11, 2018 updated by: Edward Kijak, Pomeranian Medical University Szczecin

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

The aim of the study was to assess the effectiveness of the combined physiotherapeutic method, which uses a slow-changing electromagnetic(ELF EMF) field and light energy, emitted from high-energy LEDs, in reducing pain in patients after orthognathic surgery.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 22 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • One absence during therapeutic sessions;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetoledotherapy
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)
Device: VIOFOR (Med & Life)
Device: VIOFOR (Med & Life) Magnetic-light applicators, generating a slow-changing electromagnetic field and light ener-gy (830 nm and 640 nm), emitted from LEDs during a physiotherapeutic treatment application parameters: frequency of basic field pulses: 180-195 Hz frequency of packet the field pulses: 12.5 Hz-29 Hz magnetic induction: 15 μT wavelength of light: 830 nm and 640 nm Duration: 10 min number of treatments: 10
Other Names:
  • Combination physicotherapies
  • Magnetoledotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Change from baseline in Visual Analogic Scale
Time Frame: 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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Collaborators

Ministry of Health, Poland

Investigators

  • Study Director: Edward Kijak, DSc, Pomeranian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2016

Primary Completion (Actual)

September 15, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

January 7, 2018

First Submitted That Met QC Criteria

January 7, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KB-0012/149/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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