Different Treatment Modalities for Myofascial Pain

Completed

• Conditions: Myofascial Pain; Low-Level Laser Therapy; Splints

• Registration Number: NCT04257903
• Lead Sponsor: Trakya University

Brief 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. 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 Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Study First Submitted: 2020-01-28
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-05
• Last Update Submitted: 2020-02-05
• Study First Posted: 2020-02-06
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline Visual Analogue Scale	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 Outcome Measures

Name	Time	Method
Change from Baseline maximum unassisted mouth opening	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.

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Merkez, Edirne, Turkey