Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000508077
Ethics application status
Approved
Date submitted
3/06/2010
Date registered
21/06/2010
Date last updated
6/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Intra-oral myofascial therapy compared to education and self care for chronic myogenous temporomandibular disorder. A randomised trial
Scientific title
In patients with chronic myogenous temporomandibular disorder is manual therapy of the jaw muscles more effective than education and self care in decreasing pain and increasing interincisal opening range of the jaw?
Secondary ID [1] 251947 0
none
Universal Trial Number (UTN)
U1111-1115-4495
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic myogenous temporomandibular disorder 257518 0
Condition category
Condition code
Musculoskeletal 257678 257678 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 257757 257757 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manual therapy (intra-oral myofascial manual therapy) of jaw muscles involving two treatments of 10-15 minutes duration each session per week for five weeks
Intervention code [1] 256615 0
Rehabilitation
Intervention code [2] 256680 0
Treatment: Other
Comparator / control treatment
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 (demonstrated by the therapist during the first session and then the participant is monitored performing them once each session for a total of 5 sessions, once a week for 5 weeks). The exercises are also to be performed at home 2x daily for 5 minutes for the duration of the trial (5 weeks)
Control group
Active

Outcomes
Primary outcome [1] 258584 0
jaw pain on an 11 point graded chronic pain scale
Timepoint [1] 258584 0
baseline, six weeks
Secondary outcome [1] 264469 0
jaw opening range in mm using vernier calipers
Timepoint [1] 264469 0
baseline, six weeks

Eligibility
Key inclusion criteria
chronic jaw pain 3/10 or greater on a graded chronic pain scale of at least 3 months duration
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
head and neck trauma, neoplasia of head and neck, edentulous patients, less than 3/10 on a 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
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257105 0
University
Name [1] 257105 0
Macquarie University
Country [1] 257105 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
North Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 256367 0
None
Name [1] 256367 0
Address [1] 256367 0
Country [1] 256367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259147 0
Macquarie University Human Ethics Review Committee
Ethics committee address [1] 259147 0
North Ryde NSW 2109
Ethics committee country [1] 259147 0
Australia
Date submitted for ethics approval [1] 259147 0
04/06/2010
Approval date [1] 259147 0
Ethics approval number [1] 259147 0
5201000771

Summary
Brief summary
The primary purpose of the study is to test whether intra-oral myofascial therapy for chronic myogenous temporomandibular disorder is more effective than education and self care in the short term
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31260 0
Address 31260 0
Country 31260 0
Phone 31260 0
Fax 31260 0
Email 31260 0
Contact person for public queries
Name 14507 0
Allan Kalamir
Address 14507 0
249 Edensor Road Edensor Park NSW 2176
Country 14507 0
Australia
Phone 14507 0
+61-2-98220066
Fax 14507 0
Email 14507 0
[email protected]
Contact person for scientific queries
Name 5435 0
Allan Kalamir
Address 5435 0
249 Edensor Road Edensor Park NSW 2176
Country 5435 0
Australia
Phone 5435 0
+61-2-98220066
Fax 5435 0
Email 5435 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.