Condition category
Signs and Symptoms
Date applied
28/08/2015
Date assigned
10/09/2015
Last edited
04/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Myofascial pain is a long-term pain disorder, in which pain, tenderness and muscle spasms are felt in facial muscles. The masticatory muscles include all of the muscles that are responsible for movement of the jaw. These muscles are often the most affected in cases of myofascial pain, as their involvement in chewing (mastication) means that they are used a lot. Two of the most common points where this pain is felt are the masseter muscle, which is the main muscle involved in chewing, and the temporalis muscle, which is involved in closing the mouth and moving the mouth from side to side when chewing. Low-level laser therapy (LLLT) is a treatment which uses specific wavelengths of light to stimulate the cells in the body that repair tissue, reduce inflammation, and reduce pain. This non-invasive treatment has proven to be very effective for treating back and neck pain, as well as other long term pain conditions. The aim of this study is to investigate whether applying LLLT to the point of greatest pain would help to reduce masticatory muscle pain.

Who can participate?
Adults with a diagnosis of myofascial pain and natural posterior occlusion (the teeth at the back of the mouth are aligned correctly).

What does the study involve?
Participants are randomly allocated into one of three groups. For participants in the first group, the low level laser is applied precisely and continuously to the places where pain is greatest in the related muscle. For participants in the second group, the laser is applied to three previously chosen points on the masseter muscle and three points on the temporalis muscle. For participants in the third group, the laser device is switched on, but not programmed to target any particular points. Levels of pain and movement range are assessed before and after the laser treatment.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Istanbul University Faculty of Dentistry Department of Prosthodontics (Turkey)

When is the study starting and how long is it expected to run for?
September 2010 to October 2011

Who is funding the study?
Istanbul University Faculty of Dentistry Department of Prosthodontics (Turkey)

Who is the main contact?
Dr Bilge Gokcen-Rohlig

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bilge Gokcen-Rohlig

ORCID ID

http://orcid.org/0000-0003-3143-9668

Contact details

Istanbul University Faculty of Dentistry Department of Prosthodontics
Capa
Istanbul
34390
Turkey

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Early results of low-level laser application for masticatory muscle pain: a double-blind randomized clinical study

Acronym

Study hypothesis

Direct application of low-level laser therapy (LLLT) at the point of greatest pain would reduce muscle pain to a greater degree than would application at pre-established points and placebo.

Ethics approval

Ethics Committee of the Istanbul University Faculty of Medicine , 10/05/2012, ref: 2011/1272-639

Study design

Single-centre randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Masticatory pain

Intervention

Participants were divided randomly into three age- and sex-matched groups:
1. Laser group (LGI) in which low level laser is applied precisely and continuously to the greatest points of pain in the related muscle (masseter and/or temporalis).
2. Laser group II (LGII) in which LLLT is applied in the same manner to three predetermined points on the masseter muscle (superior [MS], middle [MM], and inferior [MI] points) and three points on the temporalis muscle (anterior [TA], middle, and posterior points)
3. Placebo group (PG) in which the laser device was switched on, but not programmed.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Mandibular movement range (right, left and protrusion) before and after the assigned treatments, pain on palpation by masseter muscles on three points (superior, middle and inferior points), temporals muscles on three points (anterior, middle and posterior points) and pressure pain thresholds for the same points by algometer.

Secondary outcome measures

Pressure pain thresholds of the examined muscles are investigated before and after each treatment via visual analogue score (VAS), before any after the treatments

Overall trial start date

01/09/2010

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD)
2. Aged between 18–60 years
3. Natural posterior occlusion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1.Disc displacement with reduction or without reduction with or without limited opening, arthralgia, arthritis, or arthrosis
2. General inflammatory connective tissue disease (e.g. rheumatoid arthritis)
3. Psychiatric disorder
4. Tumour
5. Hearth disease or pacemaker
7. Pregnancy
8. Symptoms that could be referred to other orofacial region diseases (e.g. toothache, neuralgia, migraine)
9. Treatment or medication use for headache or bruxism in the last 2 years
10. Local skin infection over the masseter muscle

Recruitment start date

01/09/2010

Recruitment end date

01/10/2011

Locations

Countries of recruitment

Turkey

Trial participating centre

Istanbul University Faculty of Dentistry Department of Prosthodontics
Istanbul universitesi dis hek. fak. cene yuz protezi 6.kat Capa
Istanbul
34390
Turkey

Sponsor information

Organisation

Istanbul University Faculty of Dentistry Department of Prosthodontics

Sponsor details

Istanbul University Faculty of Dentistry Department of Prosthodontics
Capa
Istanbul
34390
Turkey

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Istanbul University Faculty of Dentistry Department of Prosthodontics

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Manuscript has been submitted to BMC Oral Health.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26496720

Publication citations

Additional files

Editorial Notes

04/11/2015: Publication reference added.