Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000308099
Ethics application status
Approved
Date submitted
13/04/2010
Date registered
19/04/2010
Date last updated
19/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Global body posture and plantar pressures distribution in individuals with and without temporomandibular disorders
Scientific title
Body posture and plantar pressures in individuals with and without temporomandibular disorders
Secondary ID [1] 1616 0
nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular disorder (TMD) 257144 0
Condition category
Condition code
Musculoskeletal 257301 257301 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The posture analysis of subjects with and without temporomandibular disorder was carried out by photogrammetry (SAPo v 0.68). Also, the distribution of plantar pressures was evaluated by baropodometry (software Footwork), both at rest and maximum intercuspal jaw position. The approximate duration of the assessments was two hours and the overall study was six months.
Intervention code [1] 256299 0
Not applicable
Comparator / control treatment
subjects with and without temporomandibular disorder were compared
Control group
Active

Outcomes
Primary outcome [1] 258210 0
Global body posture as assessed using photogrammetry
Timepoint [1] 258210 0
at time of participants' recruitment
Secondary outcome [1] 263859 0
Plantar pressure distribution as assessed using baropodometry
Timepoint [1] 263859 0
at time of participants' recruitment

Eligibility
Key inclusion criteria
As inclusion criteria for the study group (SG), it was considered temporomandibular disorder diagnosed by dental evaluation and /or presence of signals and symptoms or the dysfunction. For the control group (CG), it was considered absence of pain in the shoulder and cervical region, facial pain and/or headache, noises and limitation in the mandibular function.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of neuro-psychomotor disturbance, to be or have been submitted to physical therapy, speech therapy or orthodontics treatment (less than six months); pain complain in the inferior limbs; labyrinthic problems; squint; history of orthopedic trauma or malformation in the facial region, systemic or rheumatologic disease and use of analgesic, anti-inflammatory, muscular relaxants or anti-depressive medicine.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2584 0
Brazil
State/province [1] 2584 0

Funding & Sponsors
Funding source category [1] 256799 0
Self funded/Unfunded
Name [1] 256799 0
Juliana Alves Souza
Country [1] 256799 0
Brazil
Primary sponsor type
Individual
Name
Juliana Alves Souza
Address
Federal University of Santa Maria, Department of Physical Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country
Brazil
Secondary sponsor category [1] 256075 0
Individual
Name [1] 256075 0
Eliane Correa
Address [1] 256075 0
Federal University of Santa Maria, Department of Physical Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country [1] 256075 0
Brazil

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 31043 0
Address 31043 0
Country 31043 0
Phone 31043 0
Fax 31043 0
Email 31043 0
Contact person for public queries
Name 14290 0
Juliana Alves Souza
Address 14290 0
Federal University of Santa Maria, campus, KM 09 highway, Camobi, Department of Physical Therapy, Santa Maria, RS, CEP 97119000
Country 14290 0
Brazil
Phone 14290 0
55-55-32208234
Fax 14290 0
Email 14290 0
[email protected]
Contact person for scientific queries
Name 5218 0
Eliane Correa
Address 5218 0
Federal University of Santa Maria, campus, KM 09 highway, Camobi, Department of Physical Therapy, Santa Maria, RS, CEP 97119000
Country 5218 0
Brazil
Phone 5218 0
55-55-32208234
Fax 5218 0
Email 5218 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.