Myofascial PainNCT04257903
Different Treatment Modalities for Myofascial Pain
An observational study of Myofascial Pain and Splints, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Myofascial pain dysfunction syndrome (MPDS) is the most common reason for pain and limited function of the masticatory system. The low-level laser therapy (LLLT) and occlusal splint therapy (OST) are therapeutic options for MPDS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myofascial Pain, Splints, Low-Level Laser Therapy
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Apr 2019
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Adult
Study population: Thracian region
Who may be able to join
- Diagnosis of myofascial pain syndrome according to The Research Diagnostic Criteria for Temporomandibular Disorder.
- Individuals between the ages of 18-60
- Occlusion of individuals with posterior teeth
- Forms of individuals who do not have any systemic disease
Who cannot join
- Disc displacement with or without reduction, with or without limited mouth opening, arthralgia, arthritis, arthrosis
- Inflammatory connective tissue disease (such as rheumatoid arthritis)
- Psychiatric diseases
- Tumor
- Heart diseases
- Pregnancy
Show all 9Show fewer
- Diseases that may cause pain symptoms in other orofacial regions (toothache, neuralgia, migraine)
- Having received any treatment for headache or bruxism in the last 2 years
- Skin infections on the masseter and temporal muscles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Different Treatment Methods in Patients With Myofascial Pain Syndrome
Myofascial pain dysfunction syndrome (MPDS) is the most common reason for pain and limited function of the masticatory system. The low-level laser therapy (LLLT) and occlusal splint therapy (OST) are therapeutic options for MPDS. This study aims to evaluate the effect of LLLT and OST on pain relief and mandibular movement improvement in patients with myofascial pain.
Read the detailed description
Myofascial pain dysfunction syndrome in the masticatory muscles is the most common temporomandibular disorder. Patients suffer from pain and muscle tenderness and may present with or without restricted mouth opening. The etiology of myofascial pain dysfunction syndrome is multifactorial including psychological factors, occlusion imbalance, and parafunctional habits. Treatments for myofascial pain dysfunction syndrome include education, self-care, physical therapy, use of intra-oral appliances, short-term pharmacotherapy, behavioral therapy, and relaxation techniques.
Temporomandibular disorder is most often treated using occlusal splints safely to reduce temporomandibular joint load, and subsequently, clinical symptoms, as a reversible therapy. Occlusal splints need to be used for at least three months to eliminate temporomandibular disorders.
One of physical therapy is laser treatment. Laser treatment on tissues provides a clinical effect called biostimulation, where the basic mechanism occurs at the molecular level.
The low-level laser has non-invasive and inoffensive characteristics at appropriate parameters.
- Conditions
- Myofascial Pain, Splints, Low-Level Laser Therapy
- Keywords
- Myofacial Pain, Occlusal Splint, Low-Level Laser Therapy
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal Splint Therapy | The data of patients who previously received occlusal splint therapy were evaluated. Participants in the study received occlusal splint therapy, but the investigator did not assign this intervention specifically to the study participants. Participants received occlusal splint therapy as part of routine medical care, and a researcher studied the effect of occlusal splint therapy. | |
| Low-Level Laser Therapy | The data of patients who previously received Low-Level Laser Therapy were evaluated. Participants in the study received Low-Level Laser Therapy, but the investigator did not assign this intervention specifically to the study participants. Participants received Low-Level Laser Therapy as part of routine medical care, and a researcher studied the effect of Low-Level Laser Therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Visual Analogue Scale
Pain intensity during muscle palpations. Scores are ranging from 0 to 10. Higher scores mean a worse outcome.
Measured: Baseline, one month after the beginning of treatment and two months after the beginning of treatment
Secondary outcomes (1)
Change from Baseline maximum unassisted mouth opening
Value of Maximum unassisted mouth opening as a centimeter. Scores are ranging from 0 to 45 centimeters. Higher scores mean a better outcome.
Measured: Baseline, one month after the beginning of treatment and two months after the beginning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Apr 2019
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Kurt, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257903
- Sponsor's protocol ID
- TUFT-BAEK 2019/114
- Status last verified
- Feb 2020
- First submitted
- 28 Jan 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Treatment Methods in Patients With Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT04257903
- Acronym / sponsor ID
- TUFT-BAEK 2019/114
- Conditions
- Myofascial Pain, Splints, Low-Level Laser Therapy
- Keywords
- Myofacial Pain, Occlusal Splint, Low-Level Laser Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 6 Feb 2020 (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.
Myofascial pain dysfunction syndrome (MPDS) is the most common reason for pain and limited function of the masticatory system. The low-level laser therapy (LLLT) and occlusal splint therapy (OST) are therapeutic options for MPDS. This study aims to evaluate the effect of LLLT and OST on pain relief and mandibular movement improvement in patients with myofascial pain.
Detailed description
Myofascial pain dysfunction syndrome in the masticatory muscles is the most common temporomandibular disorder. Patients suffer from pain and muscle tenderness and may present with or without restricted mouth opening. The etiology of myofascial pain dysfunction syndrome is multifactorial including psychological factors, occlusion imbalance, and parafunctional habits. Treatments for myofascial pain dysfunction syndrome include education, self-care, physical therapy, use of intra-oral appliances, short-term pharmacotherapy, behavioral therapy, and relaxation techniques.
Temporomandibular disorder is most often treated using occlusal splints safely to reduce temporomandibular joint load, and subsequently, clinical symptoms, as a reversible therapy. Occlusal splints need to be used for at least three months to eliminate temporomandibular disorders.
One of physical therapy is laser treatment. Laser treatment on tissues provides a clinical effect called biostimulation, where the basic mechanism occurs at the molecular level.
The low-level laser has non-invasive and inoffensive characteristics at appropriate parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusal Splint Therapy | – | –The data of patients who previously received occlusal splint therapy were evaluated. Participants in the study received occlusal splint therapy, but the investigator did not assign this intervention specifically to the study participants. Participants received occlusal splint therapy as part of routine medical care, and a researcher studied the effect of occlusal splint therapy. |
| Low-Level Laser Therapy | – | –The data of patients who previously received Low-Level Laser Therapy were evaluated. Participants in the study received Low-Level Laser Therapy, but the investigator did not assign this intervention specifically to the study participants. Participants received Low-Level Laser Therapy as part of routine medical care, and a researcher studied the effect of Low-Level Laser Therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Thracian region
Key inclusion criteria (4 listed)
- Diagnosis of myofascial pain syndrome according to The Research Diagnostic Criteria for Temporomandibular Disorder.
- Individuals between the ages of 18-60
- Occlusion of individuals with posterior teeth
- Forms of individuals who do not have any systemic disease
Key exclusion criteria (9 listed)
- Disc displacement with or without reduction, with or without limited mouth opening, arthralgia, arthritis, arthrosis
- Inflammatory connective tissue disease (such as rheumatoid arthritis)
- Psychiatric diseases
- Tumor
- Heart diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline Visual Analogue Scale
Time frame: Baseline, one month after the beginning of treatment and two months after the beginning of treatment
Pain intensity during muscle palpations. Scores are ranging from 0 to 10. Higher scores mean a worse outcome.
1 secondary outcome
Change from Baseline maximum unassisted mouth opening
Time frame: Baseline, one month after the beginning of treatment and two months after the beginning of treatment
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 6 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Pain and Splints, run by Trakya University at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from Baseline Visual Analogue Scale (time frame: Baseline, one month after the beginning of treatment and two months after the beginning of treatment). 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 6 Feb 2020.