Low level laser treatment for masticatory muscle pain
| ISRCTN | ISRCTN95474981 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95474981 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/08/2015
- Registration date
- 10/09/2015
- Last edited
- 04/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
Istanbul University Faculty of Dentistry Department of Prosthodontics
Capa
Istanbul
34390
Türkiye
 ORCID ID |
0000-0003-3143-9668 |
|---|
Study information
| Study design | Single-centre randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Early results of low-level laser application for masticatory muscle pain: a double-blind randomized clinical study |
| Study objectives | 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(s) | Ethics Committee of the Istanbul University Faculty of Medicine , 10/05/2012, ref: 2011/1272-639 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/09/2010 |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Capa
Istanbul
34390
Türkiye
Sponsor information
Hospital/treatment centre
Istanbul University Faculty of Dentistry Department of Prosthodontics
Capa
Istanbul
34390
Türkiye
"ROR" |
https://ror.org/03a5qrr21 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Manuscript has been submitted to BMC Oral Health. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/10/2015 | Yes | No |
Editorial Notes
04/11/2015: Publication reference added.
