Condition category
Digestive System
Date applied
20/02/2011
Date assigned
28/02/2011
Last edited
28/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marcelo Dohnert

ORCID ID

Contact details

Rua Ercílio Farias Alves,37
Bairro Igra Sul
Torres
95560-000
Brazil
+55 51 8425 2918
mdohnert@ig.com.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Laser Therapy and Transcutaneous Electrical Nerve Stimulation (TENS) in the treatment of Temporomandibular Disorder: A randomised controlled trial

Acronym

Study hypothesis

Temporomandibular disorders affect the masticatory muscles, the TMJ and adjacent structures. The main symptomatology is myofascial pain and mandibular dysfunction. One of the main causes of pain is a muscle spasm that may be generated by muscle distension, contraction or fatigue. These conditions are caused by muscle hyperactivity, which, in turn, may be caused by bruxism or emotional factors, such as stress. The incidence of TMDs has been increasing, especially among women.

Both laser therapy and transcutaneous electrical stimulation are effective in the treatment of Temporomandibular Disorder (TMD)
1. Transcutaneous electrical stimulation is more effective than laser therapy in temporomandibular disorders analgesia
2. Laser therapy produces a more significant improvement in joint mobility of the temporomandibular joint (TMJ) in relation to transcutaneous electrical stimulation and the control group
3. The combination of laser therapy and transcutaneous electrical stimulation produced a significant improvement in quality of life of patients TMD.

Ethics approval

Human and Animal Research Ethics Committee of the Lutheran University of Brazil (Universidade Luterana do Brasil), approved on 5th July 2010, reference number: 2010-232H

Study design

Randomised clinical equivalence trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Temporomandibular Disorders

Intervention

1. The patients were randomly divided into four groups:
1.1. Control group, with 9 subjects, receiving continuous dental treatment
1.2. Group laser, with 8 subjects, receiving dental treatment plus low-frequency laser therapy
1.3. Group TENS, with 6 subjects, receiving dental treatment, in addition to TENS
1.4. Group laser + TENS, with 7 subjects, receiving dental treatment plus transcutaneous electrical nerve stimulation and laser therapy

2. Laser Therapy Protocol
A previously calibrated, low-level gallium arsenide (AsGa) endophoton laser was used (KLD®, Amparo, SP, Brazil), with a wavelength of 904 nm, energy density of 6 J/cm2, average power of 50 mW and beam area of 0.035 cm2, with continuous emission for 36 seconds per point. Laser application was performed punctually and in contact with the surface, perpendicular to the skin and bilaterally.

3. TENS Protocol
For the application of TENS, previously calibrated TENS Vif four 993 equipment (Quark®), manufactured in Piracicaba, in the state of São Paulo, Brazil, was used. Two channels with four rectangular silicon-carbon transcutaneous electrodes (3 cm x 5 cm) were used. These electrodes were placed bilaterally on the preauricular region and on the masseter muscle, with one channel for the right side and one for the left side. The adopted parameter was 40 Hz frequency, modulated at 50%, pulse width of 200 µs and motor threshold intensity, which was identified by visible muscle contraction.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. All treatment groups showed an improvement in pain, according to the Visual Analogue Scale (VAS), after physiotherapy. The laser (p=0.001) and laser + TENS groups were significantly better (p=0.005) than the control group.
2. According to the RDC/TMD questionnaire, there was an improvement in the laser (p=0.016) and laser + TENS (p=0.008) groups compared to the
control group.
3. Surface electromyography (sEMG) showed improvements in all treatment groups when comparing pre-treatment and post-treatment, but only the laser + TENS group showed improvement in both the masseter and temporal muscles in relation to the control group. The range of joint motion significantly increased only for the mandible retraction movement in the laser group (p=0.003).

Secondary outcome measures

1. There were no significant changes of the variables before and after treatment in the control group. Only the variable pain, measured by the VAS, increased from 2.0 points in the initial assessment to 4.44 points in the final assessment.
2. All treatment groups showed a significant improvement in pain, according to the VAS, after treatment. The laser + TENS group had a mean initial score of five, which was reduced to one in the final assessment. In relation to the control group, only the laser and laser + TENS groups had significantly lower values (in the laser group, p=0.001; in the laser + TENS group, p=0.005).
3. For the pain results obtained by the RDC/TMD axis II questionnaire, only the TENS and laser + TENS groups were different in relation to the control. Within the groups, there were improvements in pain of 17.5 points in the initial assessment to 13.83 points after treatment in the TENS group (p=0.016) and of 17.86 points to 13.43 points in the laser + TENS group (p=0.008).
4. In relation to the electromyographic activity of the masticatory muscles, the laser + TENS group showed significantly better mean values in relation to the control group in the activation of the left temporal muscle (p=0.023). For the right temporal muscle, the laser and TENS groups showed significant scores in relation to the control group (p=0.043 and p=0.05, respectively). For the right masseter muscle, the TENS and laser + TENS groups showed significantly greater electrical activity than the control group. Finally, the left masseter muscle showed similar results to the right masseter muscle, and activity was significantly greater in the TENS and laser + TENS groups. However, all treatment groups showed increased electrical activity in the masseter and temporal muscles in relation to the initial assessment.
5. The range of motion of the temporomandibular joint showed significant improvement during the mandibular retraction movement only in the laser group, increasing from 6.58 degrees in the initial assessment to 11.73 degrees in the final assessment (p=0.003) and during the opening movement only in the laser + TENS group, in which there was an improvement from 12.52 degrees in the initial assessment to 16.79 degrees in the final assessment (p=0.02).

Overall trial start date

01/08/2010

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Temporomandibular joint dysfunction in patients with dental treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

58 patients with a diagnosis of temporomandibular disorder

Participant exclusion criteria

1. Volunteers that did not suffer from pain in the masticatory muscles,
2. Volunteers who experienced changes in surface sensitivity
3. Volunteers who had had some type of physical therapy treatment for TMD

Recruitment start date

01/08/2010

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Ercílio Farias Alves,37
Torres
95560-000
Brazil

Sponsor information

Organisation

Lutheran University of Brazil (Universidade Luterana do Brasil) (Brazil)

Sponsor details

c/o Prof Marcelo Dohnert
Rua Universitária
1900
Torres
95560-000
Brazil
+55 51 3626 2000
mdohnert@ig.com.br

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Lutheran University of Brazil (Universidade Luterana do Brasil) (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes