Different Treatment Modalities for Myofascial Pain

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Turkey
  • Edirne
    • Merkez, Edirne, Turkey, 22030
      • Trakya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Thracian region

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Visual Analogue Scale	Pain intensity during muscle palpations. Scores are ranging from 0 to 10. Higher scores mean a worse outcome.	Baseline, one month after the beginning of treatment and two months after the beginning of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, one month after the beginning of treatment and two months after the beginning of treatment

Collaborators and Investigators

• Sponsor: Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 5, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Myofacial Pain; Low-Level Laser Therapy; Occlusal Splint
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes
• Other Study ID Numbers: TUFT-BAEK 2019/114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No