Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000096954
Ethics application status
Approved
Date submitted
18/01/2011
Date registered
28/01/2011
Date last updated
28/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture in the Temporomandibular Disorder: electromyographic analysis
Scientific title
Acupuncture in the Temporomandibular Disorder: electromyographic analysis
Secondary ID [1] 253443 0
the trial has not a secondary ID
Universal Trial Number (UTN)
U1111-1119-1225
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular disorder 260991 0
Condition category
Condition code
Physical Medicine / Rehabilitation 259124 259124 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The acupuncture therapy was performed twice a week, with an average of 30 minutes for five uninterrupted weeks in individuals with temporomandibular disorders. The subjects were evaluated before, immediately after and after 10 sessions by surface electromyography of the masticatory muscles. The temporomandibular acupuncture points of needling were ST5, ST7, TH17, Taiyang, , Yntang, LI4 and GB43, placed in the subject's face, hands and foot.
Intervention code [1] 257885 0
Treatment: Devices
Intervention code [2] 257929 0
Treatment: Other
Comparator / control treatment
No treatment group
Control group
Active

Outcomes
Primary outcome [1] 261976 0
There was significant reduction in the EMG activity of the left temporallis muscle (p= 0.0062) at rest mandibular position
Timepoint [1] 261976 0
Immediately after the acupuncture session
Primary outcome [2] 261977 0
There was significant reduction in the EMG activity of the left and right temporallis muscles (p= 0.009 and p= 0.002, respectively), at rest mandibular position.
Timepoint [2] 261977 0
After 10 sessions of the treatment (five weeks)
Primary outcome [3] 261978 0
No difference were observed in the EMG activity of the evaluated muscles during maximal intercuspal position.
Timepoint [3] 261978 0
Immediately after each individual session, and then after ten sessions of acupuncture
Secondary outcome [1] 268907 0
An improvement between the masseter and temporalis muscles balance, observed by means of the electromyographic analyzis, was obtained with the treatment.
Timepoint [1] 268907 0
After 10 sessions of acupuncture (five weeks)

Eligibility
Key inclusion criteria
Subjects with complain of pain in the orofacial region and masticatory muscles.
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of dental flaws and subjects under physiotherapeutic or odontological treatment

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)
The first 20 volunteers in the waiting list for treatment took part in the study group and next 20 took part in the control group.
Masking / blinding
Open (masking not 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
Completed
Date of first participant enrolment
Anticipated
10/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3147 0
Brazil
State/province [1] 3147 0
Rio Grande do Sul

Funding & Sponsors
Funding source category [1] 258354 0
University
Name [1] 258354 0
Federal University of Santa Maria
Country [1] 258354 0
Brazil
Primary sponsor type
University
Name
Federal University of Santa Maria
Address
Campus, University, 1000 Roraima Avenue, Camobi, Santa Maria,RS, Brazil, CEP 97105-900
Country
Brazil
Secondary sponsor category [1] 257503 0
None
Name [1] 257503 0
Address [1] 257503 0
Country [1] 257503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260329 0
Ethics Committee of Federal University of Santa Maria
Ethics committee address [1] 260329 0
1000, Roraima Avenue, Camobi, Santa Maria, RS,
CEP 97105-900
Ethics committee country [1] 260329 0
Brazil
Date submitted for ethics approval [1] 260329 0
Approval date [1] 260329 0
27/01/2009
Ethics approval number [1] 260329 0
0281.0.243.000-08

Summary
Brief summary
Since, temporomandibular is a prevalent condition which causes pain in orofacial region and masticatory muscles, the acupuncture is a therapeutic method that can benefit these patients, yet this is not already enough demonstrated.The study aims to verify the effect of the acupuncture in the electrical activity of masticatory muscles.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32111 0
Address 32111 0
Country 32111 0
Phone 32111 0
Fax 32111 0
Email 32111 0
Contact person for public queries
Name 15358 0
Eliane Correa
Address 15358 0
1040 Medianeira Avenue, apt 503, Santa Maria, RS, CEP 97060003
Country 15358 0
Brazil
Phone 15358 0
55-5532208234
Fax 15358 0
Email 15358 0
[email protected]
Contact person for scientific queries
Name 6286 0
Eliane CORREA
Address 6286 0
1040 Medianeira Avenue, apt 503, Santa Maria, RS, CEP 97060003
Country 6286 0
Brazil
Phone 6286 0
55-55-32208234
Fax 6286 0
Email 6286 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.