TMJ PainNCT03398499
Physiotherapeutic Rehabilitation in Patients After Orthognathic Surgery
A study testing VIOFOR (Med & Life) in people with TMJ Pain, run by Pomeranian Medical University Szczecin.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 24 years
- Conditions the study is for
- TMJ Pain
- What is being tested?
- VIOFOR (Med & Life)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2016to 30 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- One absence during therapeutic sessions;
About this study
Official title: 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)
Read the 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.
- Conditions
- TMJ Pain
- Being tested
- VIOFOR (Med & Life)
- Keywords
- pain, orthognathic surgery, temporomandibular disorders (TMD), Electromagnetic Therapy, Light therapy
- Medical subject headings
- Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIOFOR (Med & Life)Device
Also called Combination physicotherapies, Magnetoledotherapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: VIOFOR (Med & Life) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start30 Mar 2016
- Primary completion15 Sep 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Poland
- Responsible party
- Principal investigator, Edward Kijak, Pomeranian Medical University Szczecin
- Investigators
- Edward Kijak, DSc, Study director, Pomeranian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398499
- Sponsor's protocol ID
- KB-0012/149/15
- Status last verified
- Jan 2018
- First submitted
- 7 Jan 2018
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapeutic Rehabilitation to Eliminate Temporomandibular Joint Pain in Patients After Orthognathic Surgeries
- ClinicalTrials.gov ID
- NCT03398499
- Acronym / sponsor ID
- KB-0012/149/15
- Conditions
- TMJ Pain
- Keywords
- pain, orthognathic surgery, temporomandibular disorders (TMD), Electromagnetic Therapy, Light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Collaborators
- Ministry of Health, Poland
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magnetoledotherapy | Experimental | Device: VIOFOR (Med & Life)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) |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (1 listed)
- One absence during therapeutic sessions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIOFOR (Med & Life)Also: Combination physicotherapies, MagnetoledotherapyDevice: 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 | Device | Magnetoledotherapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Kijak, DSc study director
Pomeranian Medical University
Questions about this trial
What is this clinical trial studying?
A study testing VIOFOR (Med & Life) in people with TMJ Pain, run by Pomeranian Medical University Szczecin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Change from baseline in Visual Analogic Scale (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.