The Effect of Low Level Laser Therapy (LLLT) in Myofacial Pain Syndrome

A Randomized Clinical Trial of the Effect of Low Level Laser Therapy in Myofacial Pain Syndrome

Temporomandibular disorders (TMDs) are the major cause of non-dental pain in orofacial area. Laser therapy can be considered as one of the most recent treatment approaches in the field of physiotherapy. The special features of laser light such as coherence, monochromaticity, and collimation can result in the ability of laser light to modify cellular metabolism, increase tissue repair and reduce edema and inflammation. Several studies demonstrated successful results regarding the use of low level lasers in releasing pain of musculoskeletal conditions, but there are also contradictory reports in this field, and the clinical effectiveness of this treatment modality has been debated in some review articles. A few studies evaluated the efficacy of low level laser therapy in the treatment of temporomandibular disorders and the associated myofacial pain. There are remarkable variations in the methodology of these researches and some reported insufficient data regarding the physical properties of the laser used. The aim of this study is to evaluate the effectiveness of low level laser therapy in improving the sign and symptoms of patients suffering from myofacial pain syndrome.

Study Overview

• Status: Unknown
• Conditions: Myofacial Pain Syndrome
• Intervention / Treatment: Radiation: Low level laser therapy; Radiation: Placebo group

Detailed Description

This study will be implemented on 20 patients referring to Department of Prosthetic Dentistry of Mashhad Dental School. The patients are selected according to the RDC/TMD criteria to include those having temporomandibular disorders with muscular origin. The patients will be randomly assigned to two groups: Group 1 (treatment group) will receive low level laser therapy. The laser light will be applied with 890 nm diode laser (Mustang 2000+, Russia) with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the painful muscles.

In Group 2 (placebo) the low power laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects. Laser therapy for both the treatment and placebo groups will be applied on all painful muscles three times a week for four weeks. Patients will be evaluated at the start of the treatment, after the 6th and 12th sessions of laser therapy and also one month after the end of the treatment. At each evaluation, the maximum mouth opening with or without pain and masticatory muscle tenderness will be measured. Pain will be measured through the Visual Analogue Scale (VAS). The range of lateral and protrusive mandibular movements, and the difficulty in chewing food will also be evaluated.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Khorasan
    • Mashhad, Khorasan, Iran, Islamic Republic of, 951
      • Mashhad University Of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• The patients are selected according to the RDC/TMD criteria to include those having temporomandibular disorders with muscular origin.

Exclusion Criteria:

1. Patients with disk displacement (with or without reduction)
2. patients with temporomandibular joint arthralgia or osteoarthritis
3. patients with systemic disease affecting temporomandibular joint
4. patients receiving analgesic or antidepressant drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: low level laser; In this group, the 890 nm diode laser (Ga As) Mustang 2000+, Russia) with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the painful muscles. Laser therapy for both the treatment and placebo groups will be applied on all painful muscles three times a week for four weeks.	Radiation: Low level laser therapy; Ga As diode laser (890 nm) Mustang 2000+, Russia), with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the painful muscles. Laser therapy will be applied on all painful muscles three times a week for four weeks.; Other Names: LLLT, myofacial pain syndrome, low power laser
Placebo Comparator: Placebo; In Group 2 (placebo) the low power laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects.	Radiation: Placebo group; In this group, the low power laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects. Laser therapy will be applied on all painful muscles three times a week for four weeks.; Other Names: LLLT, low level laser therapy, myofacial pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	Pain will be measured using visual analogue scale (VAS)	Up to 1 month after laser therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mouth opening measurement	The maximal mouth opening with and without pain will be measured in mm.	Up to 1 month after laser therapy
Difficulty of chewing food	A questionare will be used to classify the pain during chewing.	Up to 1 month after laser therapy

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences
• Investigators: Principal Investigator: Farzaneh Ahrari, DDS, MS, Mashhad University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: August 8, 2011
• First Submitted That Met QC Criteria: August 15, 2011
• First Posted (Estimate): August 16, 2011

Study Record Updates

• Last Update Posted (Estimate): August 16, 2011
• Last Update Submitted That Met QC Criteria: August 15, 2011
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: TMD; LLLT; low level laser therapy; myofacial pain syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Stomatognathic Diseases; Mouth Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Syndrome; Somatoform Disorders; Facial Neuralgia; Facial Pain
• Other Study ID Numbers: 88563