LASER ACUPUNCTURE TO TEMPOROMANDIBULAR DISORDER TREATMENT

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7sw5hf
• Date of registration: 02/02/2011
• Primary sponsor: Luciano Ambrosio Ferreira - Brazil
• Public title: LASER ACUPUNCTURE TO TEMPOROMANDIBULAR DISORDER TREATMENT
• Scientific title: ADJUVANT LASER ACUPUNCTURE TO OCCLUSAL SPLINT THERAPY: A CONTROLLED TRIAL IN TEMPOROMANDIBULAR DISORDERS PATIENTS
• Date of first enrolment: 01/02/2011
• Target sample size: 40
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7sw5hf/
• Study design: Randomized double-blind controlled study.

Countries of recruitment

Brazil

Contacts

• Name: Luciano Ferreira
• Affiliation: Universidade Federal de Juiz de Fora

• Name: Luciano Ferreira
• Affiliation: Universidade Federal de Juiz de Fora

Key inclusion & exclusion criteria

Inclusion criteria: All subjects participated in this study volunteers by signing the consent
• female subjects;
• aged between 20 and 40;
• irrespective of race, creed or social level;
• presence of a diagnosis of myofascial pain and arthralgia orofacial chronic, persisting for a minimum period of six months;
• minimum intensity of muscle and joint pain of 4.0 points, measured in the Visual Analog Scale (VAS) during the first evaluation.
Exclusion criteria: Subjects with evidence of muscle diseases, rheumatic and joint systemic origin, such as fibromyalgia and rheumatoid arthritis;
• presence of fungal skin changes, hyperplastic, erythematous keloid or continuity in areas related to acupuncture points;
• medical, pharmacological, psychological or physical therapy for temporomandibular disorder (TMD), concomitant therapies introduced in this study;
• pregnants, the possible influence of intrauterine contraction and movement promoted by some acupuncture points such as LI4;
• report or finding of facial trauma as a possible etiology of temporomandibular disorder;
• individuals who have undergone prior treatment with neuromuscular relaxing plate, acupuncture or laser therapy for temporomandibular disorder;
• subject denture wearers an upper or lower;
• individuals with intellectual disability or impairment that would hinder the collection of data.

Age minimum: 20Y
Age maximum: 40Y
Gender: F

Health Condition(s) or Problem(s) studied

Temporomandibular disorder, stress
C05.500.607.221.897
F01.145.126.990

Intervention(s)

In order to reduce the likelihood of systematic errors and allow the use of statistical tests, there will be a simple procedure of random allocation of subjects of this research, which will be distributed in two groups of 20 subjects by drawing lots. Each group will receive a specific treatment modality for TMD defined as follows: 1) Group Therapy - neuromuscular relaxing splint and laser
acupuncture; 2) Control Group - neuromuscular
relaxing relaxing splint and placebo laser. Within each group, the therapeutic will be maintained until the end of the study, the patients being aware voluntary and consistent with the possibility
of receiving one of two proposed therapies
(therapeutic or placebo), were not informed during the processing of their nature therapies. At the end of the study, patients receiving a placebo therapy may undergo therapy for active laser acupuncture if they have persistent symptoms or if they wish. Simple randomisation by using sealed opaque envelope is assumed. In each subject is
assigned a sealed opaque envelope, where
information about the group to which belong will be contained. The number of envelopes for the therapeutic group is equal to the control group,the envelopes being identical with each other. The
draw will be conducted by a person without any link to the survey, which will be in the custody of groups and their participants, the researcher revealed only when the first therapeutic application.
Describe the methods used to generate the sequence in which subjects will be
randomised (sequence generation):
Simple randomisation by using a randomisation table created by computer software (SPSS for Windows 13.0) through computerised sequence generation.

Study Group Intervention:
Low intensity laser acupuncture to temporomandibular disorder treatment, directed to study group. The acupuncture points: S6, SI19, GB20, LI4, L3, SJ3, GB34, Ex-3, low power (50mW) infrared laser, for 90s each, with the obje

Primary Outcome(s)

Physical symptoms evaluation before the intervention and after 1, 2 and 3 months after the intervention. Measurement of muscle and joint pain orofacial by applying the visual analogue scale to palpation stomatognathic sites . At each time, the average intensity of pain experienced by each group will be mensured. The provision of these temporal averages (moments of 0, 1, 2 and 3) will prepare the development of physical symptoms in each group. This evolution will be compared between the groups in order to verify the effectiveness of proposed therapies.

Diagnostic Criteria for Temporomandibular Disorders Research (RDC / TMD, Axis II) to assess the psychosocial impact of emotional distress associated to temporomandibular disorder. Levels of depression and no specific sumptoms (somatization) will be measured through SCL 90R questionary, contained in RDC/DTM. This instrument will be applied before and after institution of therapy in each group. A comparison of symptoms of somatization and depression in the two instances indicate a possible change of these symptoms.

Secondary ID(s)

0253.0.180.000-08

398/2008

ACTRN12611000088943

Source(s) of Monetary Support

Universidade Federal de Juiz de Fora - Brazil

Luciano Ambrosio Ferreira - Brazil

Secondary Sponsor(s)

Amanda Buchara Pereira - Brazil

Marcos Vinicius Queiroz de Paula - Brazil

Universidade Federal de Juiz de Fora - Brazil