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OpenTrials
Completed

NCT Number: NCT04257903

Different Treatment Modalities for Myofascial Pain

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Trakya University

Merkez, Edirne, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Value of Maximum unassisted mouth opening as a centimeter. Scores are ranging from 0 to 45 centimeters. Higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

Effectiveness of Different Treatment Methods in Patients With Myofascial Pain Syndrome

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2020
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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