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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Mashhad University of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01417637
First received: August 8, 2011
Last updated: August 15, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention
Myofacial Pain Syndrome
Radiation: Low level laser therapy
Radiation: Placebo group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of the Effect of Low Level Laser Therapy in Myofacial Pain Syndrome

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • Pain relief [ Time Frame: Up to 1 month after laser therapy ] [ Designated as safety issue: No ]
    Pain will be measured using visual analogue scale (VAS)


Secondary Outcome Measures:
  • Mouth opening measurement [ Time Frame: Up to 1 month after laser therapy ] [ Designated as safety issue: No ]
    The maximal mouth opening with and without pain will be measured in mm.

  • Difficulty of chewing food [ Time Frame: Up to 1 month after laser therapy ] [ Designated as safety issue: No ]
    A questionare will be used to classify the pain during chewing.


Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: LLLT, low level laser therapy, myofacial pain

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417637

Locations
Iran, Islamic Republic of
Mashhad University of Medical Sciences
Mashhad, Khorasan, Iran, Islamic Republic of, 951
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Principal Investigator: Farzaneh Ahrari, DDS, MS Mashhad University of Medical Sciences
  More Information

No publications provided

Responsible Party: Dr Farzaneh Ahrari, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01417637     History of Changes
Other Study ID Numbers: 88563
Study First Received: August 8, 2011
Last Updated: August 15, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Mashhad University of Medical Sciences:
TMD
myofacial pain syndrome
low level laser therapy
LLLT

Additional relevant MeSH terms:
Somatoform Disorders
Facial Neuralgia
Facial Pain
Mental Disorders
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014