Physiotherapeutic Rehabilitation in Patients After Orthognathic Surgery

NCT03398499 | Completed DMC

• 1 other identifier: KB-0012/149/15
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

TMJ Pain

Keywords

pain; orthognathic surgery; temporomandibular disorders (TMD); Electromagnetic Therapy; Light therapy

Outcome Measures

Primary Outcomes (1)

• 1. Change from baseline in Visual Analogic Scale

  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

Study Arms (1)

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)

Device: VIOFOR (Med & Life)

Interventions

VIOFOR (Med & Life) DEVICE

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

Also known as: Combination physicotherapies, Magnetoledotherapy

Magnetoledotherapy

Eligibility Criteria

• Age: 19 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• One absence during therapeutic sessions;

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead
• Ministry of Health, Poland: collaborator

MeSH Terms

Conditions

Pain; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Edward Kijak, DSc

  Pomeranian Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Rehabilitation of patients after orthognathic procedures was performed, in which orthognathic surgery was performed - Bilateral Sagittal Split Osteotomy (BSSO). In the study it was used treatments a combination physicotherapies that combines two therapeutic physical factors - the electromagnetic field and the electromagnetic wave of red and infrared light in the form of led light therapy generated by the Viofor JPS device (Med\&Life, Poland). Treatments with a slow-changing electromagnetic field were carried out using ring and elliptic applicators. Treatments with magnetoledotherapy using elliptical magnetic applicators combined with light. For physiotherapeutic purposes, led lighttherapy was used, which is a combined use of Extremely Low Frequency Magnetic Field (ELF-MF) and light coming from high energy LEDs (Light Emitting Diode) in the range of red (R) and infrared (IR). Therapies were used once a day, doing three described applications for a period of 10 days.

Study Record Dates

• First Submitted: January 7, 2018
• First Posted: January 12, 2018
• Study Start: March 30, 2016
• Primary Completion: September 15, 2017
• Study Completion: October 30, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share