Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000329066
Ethics application status
Approved
Date submitted
2/11/2009
Date registered
23/04/2010
Date last updated
23/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intra-oral myofascial therapy for chronic myogenous temporomandibular disorder (TMD). A randomised controlled trial
Scientific title
In Participants with chronic myogenous temporomandibular disorder (TMD) is manual therapy or manual therapy plus education and self care exercises more effective than no treatment in decreasing pain and increasing interincisal opening range of the jaw?
Secondary ID [1] 251644 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic myogenous temporomandibular disorder 252098 0
Condition category
Condition code
Physical Medicine / Rehabilitation 252304 252304 0 0
Other physical medicine / rehabilitation
Musculoskeletal 257351 257351 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. intra-oral soft tissue manual therapy- 2 x10 minute treatments per week for 5 weeks.
Arm 2. intra-oral soft tissue manual therapy plus education and self care exercises- 2x10 minute treatments per week for 5 weeks; a short scripted dialogue of 10 minutes duration on jaw pain pathophysiology and anatomy administered face to face with a trained therapist, plus self care jaw exercises to be performed at home 2x daily for 5 minutes.
Arm 3. Wait list control
Intervention code [1] 241490 0
Rehabilitation
Comparator / control treatment
wait list control will be offered the intervention (as for Arm 1), 1 year after their first assessment.
Control group
Active

Outcomes
Primary outcome [1] 253176 0
jaw pain- Graded Chronic Pain Scale (GCPS).
Timepoint [1] 253176 0
baseline, 6 weeks, 6 months, 1 year
Secondary outcome [1] 262098 0
Range of motion in mm by vernier calipers
Timepoint [1] 262098 0
baseline, 6 weeks, 6 months, 1 year

Eligibility
Key inclusion criteria
chronic jaw pain 3/10 or greater on graded chronic pain scale (GCPS)
adult 18-50 years of age
onset of symptoms at least 3 months
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
head and neck trauma, neoplasia of head and neck, edentulous patients, less than 3/10 on graded chronic pain scale

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)
enrollment by blinded receptionist, who contacted a volunteer who held the randomization schedule (computer generated) off premises.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomization schedule (www.randomizer.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
95
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243954 0
University
Name [1] 243954 0
Macquarie University
Country [1] 243954 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
North Ryde, NSW 2109
Country
Australia
Secondary sponsor category [1] 251310 0
None
Name [1] 251310 0
Address [1] 251310 0
Country [1] 251310 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244067 0
Macquarie University Ethics Review Committee (Human Research)
Ethics committee address [1] 244067 0
North Ryde NSW 2109
Ethics committee country [1] 244067 0
Australia
Date submitted for ethics approval [1] 244067 0
Approval date [1] 244067 0
26/08/2005
Ethics approval number [1] 244067 0
HE26AUG2005-M04263

Summary
Brief summary
The primary purpose of the study is to test whether intra-oral manual therapy for chronic myogenous temporomandibular disorder coupled with self care exercises and education is more effective than either manual therapy alone or no treatment (control).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30451 0
Address 30451 0
Country 30451 0
Phone 30451 0
Fax 30451 0
Email 30451 0
Contact person for public queries
Name 13698 0
Allan Kalamir
Address 13698 0
249 Edensor Road Edensor Park NSW 2176
Country 13698 0
Australia
Phone 13698 0
+61-2-98220066
Fax 13698 0
Email 13698 0
[email protected]
Contact person for scientific queries
Name 4626 0
Allan Kalamir
Address 4626 0
249 Edensor Road Edensor Park NSW 2176
Country 4626 0
Australia
Phone 4626 0
+61-2-98220066
Fax 4626 0
Email 4626 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.