Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000171516
Ethics application status
Approved
Date submitted
27/04/2006
Date registered
12/05/2006
Date last updated
19/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
RCT of manual therapy for TMD
Scientific title
A comparison study of the clinical effectiveness of intra-oral myofascial treatment to intra-oral myofascial treatment plus education and self care and to wait list control
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular Disorder 1144 0
Condition category
Condition code
Oral and Gastrointestinal 1224 1224 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
manual therapy (10 sessions over 5 weeks)
Intervention code [1] 1000 0
Treatment: Other
Comparator / control treatment
Control group no treatment
Control group
Active

Outcomes
Primary outcome [1] 1660 0
Graded chronic pain scale measurement
Timepoint [1] 1660 0
At 5 weeks and 6 months
Secondary outcome [1] 2966 0
Temporomandibular range of motion
Timepoint [1] 2966 0
5 weeks, 6 months

Eligibility
Key inclusion criteria
Over 18 years of age, 3 month history of jaw pain
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of malignancy in head or neck, fractures of the jaw, toothlessness

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)
Allocation was performed off site by contacting a third party holding the randomisation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Urn method of Randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1336 0
University
Name [1] 1336 0
Macquarie University
Country [1] 1336 0
Australia
Primary sponsor type
Individual
Name
Allan Kalamir
Address
249 Edensor Road Edensor Park NSW 2176
Country
Australia
Secondary sponsor category [1] 1179 0
None
Name [1] 1179 0
nil
Address [1] 1179 0
Country [1] 1179 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2685 0
Macquarie University Ethics Review Committee (Human Research)
Ethics committee address [1] 2685 0
Ethics committee country [1] 2685 0
Australia
Date submitted for ethics approval [1] 2685 0
Approval date [1] 2685 0
20/10/2005
Ethics approval number [1] 2685 0
HE26AUG2005-M04263

Summary
Brief summary
To trial the clinical effectiveness of manual therapy in the treatment of temporomandibular disorder. Applicants are screened over the telephone, and if they meet exclusion/inclusion criteria are asked to complete application forms and undergo an assessment. Acceptable participants are numbered, then randomly assigned to thier respective groups by a blinded off-site person holding the randomization schedule. Control patients are blinded as to thier current status within the trial. Due to ethical considerations they will be offered free treatment at the conclusion of the trial observation period (1yr). Assessments are further carried out following intervention (week5), 6months post, and 1 yr post. Assessor is blinded as to which group the participant belongs, and the clinician is blinded to the results of assessments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35631 0
Address 35631 0
Country 35631 0
Phone 35631 0
Fax 35631 0
Email 35631 0
Contact person for public queries
Name 10189 0
Allan Kalamir
Address 10189 0
249 Edensor Road
Edensor Park NSW 2176
Country 10189 0
Australia
Phone 10189 0
(02) 9822 0588
Fax 10189 0
(02) 9822 0588
Email 10189 0
[email protected]
Contact person for scientific queries
Name 1117 0
Allan Kalamir
Address 1117 0
249 Edensor Road
Edensor Park NSW 2176
Country 1117 0
Australia
Phone 1117 0
(02) 9822 0588
Fax 1117 0
(02) 9822 0588
Email 1117 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.