Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000088943
Ethics application status
Approved
Date submitted
21/01/2011
Date registered
25/01/2011
Date last updated
25/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Laser acupuncture to temporomandibular disorder treatment
Scientific title
Adjuvant laser acupuncture to occlusal splint therapy for pain reduction: a controlled trial in temporomandibular disorder patients
Secondary ID [1] 253459 0
Brazilian Committee for Research Ethics CAAE - CONEP 0253.0.180.000-08
Secondary ID [2] 253473 0
0253.0.180.000-08 (CAAE Brazilian CONEP)
Universal Trial Number (UTN)
U1111-1119-1317
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
temporomandibular disorder and stress 261013 0
Condition category
Condition code
Musculoskeletal 259146 259146 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low intensity laser acupuncture to temporomandibular disorder treatment. The acupuncture points: S6, SI19, GB20, LI4, L3, SJ3, GB34, Ex-3, low power (50mW) infrared laser, for 90s each, with the objective of sedation.
Laser acupuncture therapy will happen weekly in one-hour sessions. Laser treatment is continuous and punctual, directed at each point for a period of 90 seconds. Twelve weekly sessions will complete three months of treatment.
The laser acupuncture therapy will follow the standards of protection for the use of lasers, including the protection of patients' eyes. Such protection inhibits the visual stimulus during application of therapy.
Neuromuscular relaxing occlusal splint is a dentistry conventional treatment directed to all participants of the research. The splints will be made of acrylic and individually adjusted by surface's sanding . The adjustment is to obtain simultaneous tooth contacts in a physiological mandibular position, where the chewing muscles and temporomandibular joints are protected from excessive occlusal loads. They will wear it for three months, at the night, when usually the involuntary muscle hyperactivity occurs. The adjustments will take place weekly, aiming occlusal changes that result in facial muscleand joint relaxation.
Intervention code [1] 257901 0
Treatment: Devices
Intervention code [2] 257902 0
Treatment: Other
Comparator / control treatment
Placebo Laser acupuncture is the intervention directed to the control group.
Acupuncture points given for temporomandibular disorders: S6, SI19, GB20, LI4, L3, SJ3, GB34, Ex-3 will receive the treatment simulation by same study group's apparatus, by 90 seconds without applying pressure or radiation. There will be no emission of laser for this group, so the power button the device will be turned to the off position. Patients wear dark protection glasses that inhibit any view. No sound is emitted by the device, even when off or on.
The issue of low power laser is painless, no sensation is felt when the true application of laser happens. The use of glasses that inhibit the view of the patient allows individuals do not know the nature of light, active or placebo.
Placebo laser acupuncture will happen weekly in one-hour sessions. The disconnected device will be directed at each point for a period of 90 seconds. Twelve weekly sessions will complete three months of placebo therapy.

Neuromuscular relaxing occlusal splint is a dentistry conventional treatment, directed to all participants, including the control group. The splints will be made of acrylic and individually adjusted by surface's sanding . The adjustment is to obtain simultaneous tooth contacts in a physiological mandibular position, where the chewing muscles and temporomandibular joints are protected from excessive occlusal loads. They will wear it for three months, at the night, when usually the involuntary muscle hyperactivity occurs. The adjustments will take place weekly, aiming occlusal changes that result in facial muscleand joint relaxation.
Control group
Placebo

Outcomes
Primary outcome [1] 261999 0
Evaluation of the first, second and third month of intervention
Measurement of muscle and joint pain orofacial by applying the visual analogue scale (0 to 10) to palpation stomatognathic sites. The individuals will indicate the intensity of pain during the palpation of the facial muscles and TMJ.
Timepoint [1] 261999 0
The original constitutional symptoms are first evaluated, before any intervention. The first intervention evaluation will happen after the first month of therapeutic application. Applied after the fourth session.
The second intervention evaluation will happen after the second month of therapeutic application. Applied after the eighth session.
The thirty interventions evaluation will happen after the thirty month of therapeutic application. Applied after the twelfth session.
Secondary outcome [1] 268931 0
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 symptoms (somatization) will be evaluated.
Timepoint [1] 268931 0
Levels of depression and no specific symptoms (somatization) before and after the institution of therapies in each group.
Secondary outcome [2] 268954 0
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 symptoms (somatization) will be evaluated.
Timepoint [2] 268954 0
The psychossocial impact will be evaluated before and after before and after all therapeutic sessions.

Eligibility
Key inclusion criteria
All subjects will be volunteers by signing the consent term;
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 VAS during the first evaluation;
Present temporomandibular disorders diagnosis according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 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 TMD;
Individuals who have undergone prior treatment with neuromuscular relaxing plate, acupuncture or laser therapy for TMD;
Subject denture wearers an upper or lower;
Individuals with intellectual disability or impairment that would hinder the collection of data.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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 18 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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 3153 0
Brazil
State/province [1] 3153 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 258376 0
Self funded/Unfunded
Name [1] 258376 0
Luciano Ambrosio Ferreira
Country [1] 258376 0
Brazil
Primary sponsor type
Individual
Name
Luciano Ambrosio Ferreira
Address
Luiz Andrade Silveira, 207, Centenario
Juiz de Fora City
Minas Gerais
Brazil
zip code: 36045-280
Country
Brazil
Secondary sponsor category [1] 257522 0
Individual
Name [1] 257522 0
Marcos Viicius Queiroz de Paula
Address [1] 257522 0
Rua Delfim Moreira, 324/102.
Grambery
Juiz de Fora City
Minas Gerais
Brazil
zip code:36010-570
Country [1] 257522 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260353 0
Comite de Etica em Pesquisa da Universidade Federal de Juiz de Fora
Ethics committee address [1] 260353 0
Ethics committee country [1] 260353 0
Brazil
Date submitted for ethics approval [1] 260353 0
03/11/2008
Approval date [1] 260353 0
26/11/2008
Ethics approval number [1] 260353 0
398/2008 CAAE: 0253.0.108.000.08

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32124 0
Address 32124 0
Country 32124 0
Phone 32124 0
Fax 32124 0
Email 32124 0
Contact person for public queries
Name 15371 0
Luciano Ambrosio Ferreira
Address 15371 0
Luiz Andrade Silveira, 207, Centenario
Zip code 36045-280
Juiz de Fora city
Minas Gerais
Brazil
Country 15371 0
Brazil
Phone 15371 0
+55 32 3224 5637
Fax 15371 0
Email 15371 0
[email protected]
Contact person for scientific queries
Name 6299 0
Luciano Ambrosio Ferreira
Address 6299 0
Luiz Andrade Silveira, 207, Centenario
Zip code 36045-280
Juiz de Fora city
Minas Gerais
Brazil
Country 6299 0
Brazil
Phone 6299 0
+55 32 3224 5637
Fax 6299 0
Email 6299 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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