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

NCT01417637 | Unknown DMC

• 1 other identifier: 88563
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myofacial Pain Syndrome

Keywords

TMD; myofacial pain syndrome; low level laser therapy; LLLT

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Pain will be measured using visual analogue scale (VAS)

  Up to 1 month after laser therapy

Secondary Outcomes (2)

• Mouth opening measurement

  Up to 1 month after laser therapy

• Difficulty of chewing food

  Up to 1 month after laser therapy

Study Arms (2)

low level laser

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Low level laser therapy RADIATION

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.

Also known as: LLLT, myofacial pain syndrome, low power laser

low level laser

Placebo group RADIATION

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.

Also known as: LLLT, low level laser therapy, myofacial pain

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with disk displacement (with or without reduction)
• patients with temporomandibular joint arthralgia or osteoarthritis
• patients with systemic disease affecting temporomandibular joint
• patients receiving analgesic or antidepressant drugs

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad University of Medical Sciences

Mashhad, Khorasan, 951, Iran

Location

MeSH Terms

Conditions

Facial Neuralgia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Farzaneh Ahrari, DDS, MS

  Mashhad University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 16, 2011

Record last verified: 2010-06

Locations

IR (1)