Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000211066
Ethics application status
Approved
Date submitted
11/03/2010
Date registered
16/03/2010
Date last updated
16/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postural Global Reeducation In Individuals With Temporomandibular Disorder And Postural Deviation: Electromyographic Analysis to Measure Improvement in Masticatory and Cervical Muscles
Scientific title
Postural Global Reeducation In Individuals With Temporomandibular Disorder And Postural Deviation: Electromyographic Analysis to Measure Improvement in Masticatory and Cervical Muscles
Secondary ID [1] 1486 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
temporomandibular disorder 256950 0
postural deviation 256951 0
Condition category
Condition code
Musculoskeletal 257091 257091 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention based on an european method known as Postural Global Reeducation and it was administered by one on one with a trained physiotherapist. It consists in adopting several body postures for stretching shortened muscles and strengthening the antagonist ones. The treatment consisted in a total of ten sessions with 1 hour of duration, once a week. Then the participant before and after results are compared.
Intervention code [1] 256127 0
Treatment: Other
Comparator / control treatment
This is a single arm study and the participant baseline results are compared to their results after intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257984 0
The electromyography exam verified a decrease of mean values of electrical activity in masticatory and cervical muscles. They were significant lower (p,0,05) at rest and postural alignment after treatment then before.
Timepoint [1] 257984 0
after ten treatment sessions
Secondary outcome [1] 263535 0
the study demontrated objectively, by electromyography, the efficacy of the Global Postural Reeducation method in the muscle activity. This muscle balance restoration seems to benefit the masticatory function.
Timepoint [1] 263535 0
after ten treatment sessions

Eligibility
Key inclusion criteria
individuals with temporomandibular disorder, diagnosed by Research Diagnostic Criteria (RDC/TMD), associated to a postural deviation
Minimum age
20 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with neuropsycomotor disorder,musculoskeletal disease, orthopaedic trauma, surgery or deformity in orofacial region and individuals previously treated (less than six months) or in treatment by physical therapy, speech therapy or dentist for these problems

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2536 0
Brazil
State/province [1] 2536 0

Funding & Sponsors
Funding source category [1] 256629 0
Self funded/Unfunded
Name [1] 256629 0
Country [1] 256629 0
Brazil
Primary sponsor type
Individual
Name
Debora Basso
Address
Rua Doutor Pantaleao, 377, CEP 97010-180, Santa Maria, RS
Country
Brazil
Secondary sponsor category [1] 255917 0
Individual
Name [1] 255917 0
Eliane Correa
Address [1] 255917 0
Avenida Medianeira 1040/503, Santa Maria, RS, 97060-003
Country [1] 255917 0
Brazil

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 30917 0
Address 30917 0
Country 30917 0
Phone 30917 0
Fax 30917 0
Email 30917 0
Contact person for public queries
Name 14164 0
Debora Basso
Address 14164 0
Rua Doutor Pantaleao, 377, Santa Maria, RS, Brazil, CEP 97010-180
Country 14164 0
Brazil
Phone 14164 0
55-55-32221757
Fax 14164 0
Email 14164 0
[email protected]
Contact person for scientific queries
Name 5092 0
Eliane Correa
Address 5092 0
Avenida Medianeira 1040/503, Santa Maria,RS, Brazil, CEP 97060-003
Country 5092 0
Brazil
Phone 5092 0
55-55-32221757
Fax 5092 0
Email 5092 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.