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Trial registered on ANZCTR


Registration number
ACTRN12614001301651
Ethics application status
Approved
Date submitted
3/12/2014
Date registered
12/12/2014
Date last updated
16/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intra-oral osteopathic technique for chronic temporomandibular joint disorders
Scientific title
The effect of intra-oral osteopathic technique on pain, maximum mouth opening, and disability in patients with chronic temporomandibular joint disorder
Secondary ID [1] 285781 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular joint disorder 293666 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293962 293962 0 0
Other physical medicine / rehabilitation
Musculoskeletal 293964 293964 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two intra-oral osteopathic techniques applied by a final year supervised Master of Osteopathy student during each of 6, 15-minute weekly treatment sessions. The first technique is a release of the masseter, temporalis and lateral and medial pterygoid muscles using inhibition. The second technique will distract the mandible from the temporal bone and articulate the joint. The aims of this treatment is to improve mobility, and create joint space and blood flow to and from the tightly compacted joint, that may facilitate cartilage repair.

Intervention code [1] 290740 0
Rehabilitation
Intervention code [2] 290780 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293737 0
McGill Pain Questionnaire - Short-Form - Sensory
Timepoint [1] 293737 0
0.5 week, 1 week, 1.5 weeks, 2 weeks, 2.5 weeks, 3 weeks, 3.5 weeks, 4 weeks, 4.5 weeks, 5 weeks, 5.5 weeks, 6 weeks, 6.5 weeks, 7 weeks, 7.5 weeks, 8 weeks, 8.5 weeks following onset of treatment
Primary outcome [2] 293738 0
Visual Analogue Scale: Pain at rest
Timepoint [2] 293738 0
0.5 week, 1 week, 1.5 weeks, 2 weeks, 2.5 weeks, 3 weeks, 3.5 weeks, 4 weeks, 4.5 weeks, 5 weeks, 5.5 weeks, 6 weeks, 6.5 weeks, 7 weeks, 7.5 weeks, 8 weeks, 8.5 weeks following onset of treatment
Primary outcome [3] 293739 0
Visual Analogue Scale: Pain during mastication
Timepoint [3] 293739 0
0.5 week, 1 week, 1.5 weeks, 2 weeks, 2.5 weeks, 3 weeks, 3.5 weeks, 4 weeks, 4.5 weeks, 5 weeks, 5.5 weeks, 6 weeks, 6.5 weeks, 7 weeks, 7.5 weeks, 8 weeks, 8.5 weeks following onset of treatment
Secondary outcome [1] 311700 0
McGill Pain Questionnaire - Short-Form - Affective
Timepoint [1] 311700 0
0.5 week, 1 week, 1.5 weeks, 2 weeks, 2.5 weeks, 3 weeks, 3.5 weeks, 4 weeks, 4.5 weeks, 5 weeks, 5.5 weeks, 6 weeks, 6.5 weeks, 7 weeks, 7.5 weeks, 8 weeks, 8.5 weeks following onset of treatment
Secondary outcome [2] 311701 0
Maximum Mouth Opening Range measured using an inflexible ruler
Timepoint [2] 311701 0
0.5 week, 1 week, 1.5 weeks, 2 weeks, 2.5 weeks, 3 weeks, 3.5 weeks, 4 weeks, 4.5 weeks, 5 weeks, 5.5 weeks, 6 weeks, 6.5 weeks, 7 weeks, 7.5 weeks, 8 weeks, 8.5 weeks following onset of treatment
Secondary outcome [3] 311702 0
Temporomandibular Disorder Disability Index
Timepoint [3] 311702 0
0.5 week, 1 week, 1.5 weeks, 2 weeks, 2.5 weeks, 3 weeks, 3.5 weeks, 4 weeks, 4.5 weeks, 5 weeks, 5.5 weeks, 6 weeks, 6.5 weeks, 7 weeks, 7.5 weeks, 8 weeks, 8.5 weeks following onset of treatment

Eligibility
Key inclusion criteria
History of persistent pain in the temporomandibular region for at least 6 weeks - at rest, clenching or opening.

Evidence of restricted temporomandibular joint range of motion as determined by an examination process which assessed maximal mouth opening, lateral deviation, protrusion, and retrusion.
Minimum age
16 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical or radio-graphical evidence of osteoporosis

History of malignancy in the skull in the last 5 years – could alter bone structure and may increase the chance of metastases.

History of fractures or dislocation of the mandible – Weakens the bone or the joint capsule which would result in an increase of risk to the subject.

Recent, severe and ongoing jaw locking.

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)
Single cohort - no control group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A sample size of 10 was calculated prior to the study using G*Power 3 (Faul and Erdfelder, 2007), as required to detect an effect size of 0.9 (assuming power of 0.8 and alpha level of 0.05). This effect size was the most conservative effect size noted for a similar previous study (Kalamir et al, 2010).

Repeated measures analysis of variance for outcome variables across all time-points


References:

Faul F, Erdfelder E, Lang A-G and Buchner A. G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods. 2007;39(2):175-191.

Kalamir, A, Pollard, H, Vitiello, A & Bonello, R. (2010). Intra-oral myofascial therapy for chronic myogenous temporomandibular disorders: a randomized, controlled pilot study. Journal of Manual and Manipulative Therapy, 18(3), 139 – 146.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6507 0
New Zealand
State/province [1] 6507 0
Auckland region

Funding & Sponsors
Funding source category [1] 290343 0
University
Name [1] 290343 0
Unitec Institute of Technology
Address [1] 290343 0
Private Bag 92025
Victoria Street West
Auckland 1142
New Zealand
Country [1] 290343 0
New Zealand
Primary sponsor type
Individual
Name
Catherine J. Bacon
Address
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289065 0
None
Name [1] 289065 0
Address [1] 289065 0
Country [1] 289065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292047 0
Unitec Research Ethics Committee
Ethics committee address [1] 292047 0
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
New Zealand
Ethics committee country [1] 292047 0
New Zealand
Date submitted for ethics approval [1] 292047 0
Approval date [1] 292047 0
09/09/2013
Ethics approval number [1] 292047 0
2013-1054

Summary
Brief summary
The aim of this study was to investigate the degree of effect on pain, mandibular range of motion, and disability of two intra-oral osteopathic techniques applied weekly for 6 weeks to patients with temporomandibular joint disorder. The aims of the treatment are to improve mobility, and create joint space and blood flow to and from the tightly compacted joint, that may facilitate cartilage repair and thus reduce pain and improve mouth opening.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53246 0
Dr Catherine J. Bacon
Address 53246 0
Department of Community and Health Services: Osteopathy Division
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
New Zealand
Country 53246 0
New Zealand
Phone 53246 0
+64 9 815 6794
Fax 53246 0
Email 53246 0
cbacon@unitec.ac.nz
Contact person for public queries
Name 53247 0
Dr Catherine Bacon
Address 53247 0
Department of Community and Health Services: Osteopathy Division
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
New Zealand
Country 53247 0
New Zealand
Phone 53247 0
+64 9 815 6794
Fax 53247 0
Email 53247 0
cbacon@unitec.ac.nz
Contact person for scientific queries
Name 53248 0
Dr Catherine J. Bacon
Address 53248 0
Department of Community and Health Services: Osteopathy Division
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
New Zealand
Country 53248 0
New Zealand
Phone 53248 0
+64 9 815 6794
Fax 53248 0
Email 53248 0
cbacon@unitec.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary