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

Primary Purpose

Myofacial Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Low level laser therapy
Placebo group
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofacial Pain Syndrome focused on measuring TMD, myofacial pain syndrome, low level laser therapy, LLLT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mashhad University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

low level laser

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain relief
Pain will be measured using visual analogue scale (VAS)

Secondary Outcome Measures

Mouth opening measurement
The maximal mouth opening with and without pain will be measured in mm.
Difficulty of chewing food
A questionare will be used to classify the pain during chewing.

Full Information

First Posted
August 8, 2011
Last Updated
August 15, 2011
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01417637
Brief Title
The Effect of Low Level Laser Therapy (LLLT) in Myofacial Pain Syndrome
Official Title
A Randomized Clinical Trial of the Effect of Low Level Laser Therapy in Myofacial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofacial Pain Syndrome
Keywords
TMD, myofacial pain syndrome, low level laser therapy, LLLT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low level laser
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Low level laser therapy
Other Intervention Name(s)
LLLT, myofacial pain syndrome, low power laser
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Placebo group
Other Intervention Name(s)
LLLT, low level laser therapy, myofacial pain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain relief
Description
Pain will be measured using visual analogue scale (VAS)
Time Frame
Up to 1 month after laser therapy
Secondary Outcome Measure Information:
Title
Mouth opening measurement
Description
The maximal mouth opening with and without pain will be measured in mm.
Time Frame
Up to 1 month after laser therapy
Title
Difficulty of chewing food
Description
A questionare will be used to classify the pain during chewing.
Time Frame
Up to 1 month after laser therapy

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients are selected according to the RDC/TMD criteria to include those having temporomandibular disorders with muscular origin. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzaneh Ahrari, DDS, MS
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashhad University of Medical Sciences
City
Mashhad
State/Province
Khorasan
ZIP/Postal Code
951
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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