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Trial registered on ANZCTR


Registration number
ACTRN12612000733875
Ethics application status
Approved
Date submitted
7/07/2012
Date registered
10/07/2012
Date last updated
3/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in masticatory mechanosensitivity, mouth opening and head posture after intervention with a myofascial induction protocol
Scientific title
Immediate changes in masticatory mechanosensitivity, vertical mouth opening and head posture after intervention with a myofascial induction protocol in healthy subjects:a randomized trial
Secondary ID [1] 280796 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Forward head posture 286854 0
Muscular Mechanosensitivity 286869 0
Mouth mobility 286870 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287178 287178 0 0
Physiotherapy
Musculoskeletal 287195 287195 0 0
Other muscular and skeletal disorders
Oral and Gastrointestinal 287196 287196 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
MYOFASCIAL INDUCTION PROTOCOL

The protocol began with an induction technique in the deep fascia of the temporal region. The subject was placed supine and the therapist sat at the head of the table. The therapist places one of her hands on the temporal muscle and the other one at the zygomatic arch. Maintaining this position, the cranial hand exerts a slight pressure in cranial direction and the caudal hand does the same in caudal direction. After reaching the relaxation of the tissue (about 4 minutes of time), the caudal hand moves toward the chest respecting any soft tissue restrictions during this advance. The technique was applied bilaterally (first in the dominant side and then in the non-dominant side of the body). Then, it was performed a myofascial technique in the masseter muscle. Remaining at the therapist-patient position, the therapist places one hand at the zygomatic arch and the other one just below, performing a cranial traction with her cranial hand and a caudal traction with the other hand. The technique lasts approximately 4 minutes.
Having performed this maneuver in both sides, the protocol was completed with the masster muscle induction in a transverse direction. For this, the therapist places three fingers on the insertion of the muscle in both zygomatic arches and sustained pressure is applied to the midline of the face.

The whole protocol lasted approximately 20 minutes and involved only a single session
Intervention code [1] 285224 0
Rehabilitation
Comparator / control treatment
The placebo manouvre consisted in the therapist placing her hands in the patient's skull keeping the same contacts that have been described for the intervention group, without any kind of pressure or therapeutic intention. The aim was to provide a manual stimulus as similar as possible to the myofascial induction protocol. The subject will be asked to keep his eyes closed as in the intervention techique. The intervention time for the placebo technique is twenty minutes and it will be performed only once.
Control group
Placebo

Outcomes
Primary outcome [1] 287473 0
IMPROVEMENT OF CRANIOVERTEBRAL ANGLE IN AT LEAST 15%

The craniovertebral angle (CVA) is measured to be that between a horizontal line that crosses the body of the seventh cervical vertebra (C7) and the line from the tragus of the ear to the spinal apophysis of C7. Two lateral photographs are taken of the subject seated and standing still. For the first photograph, the subjects are asked to sit with their arms on their legs, and to rest their back and buttocks on the back of the chair, with both feet on the ground. The examiner instructs them to fix their gaze on an imaginary point on the wall directly in front. For the second photograph, the subjects stand still in a posture as natural as possible, with arms resting along the body, and directing their gaze as in the previous case.
Timepoint [1] 287473 0
AFTER INTERVENTION
Secondary outcome [1] 298238 0
INCREASE OF VERTICAL MOUTH OPENING(VMO) IN AT LEAST 10%

The maximum amplitude of VMO is measured using a digital gauge (Fino Digital Caliper, Model 59112, Germany) with a sensitivity of 0.01 mm. Measurements are made in two positions: (i) the subject supine with flexed hips and knees, and hands resting on the abdomen; and (ii) subject seated with back support and feet resting on the floor. The instruction given to the subject is simple: "Open your mouth as much as possible without there being any sensation of pain or discomfort." The examiner then placed one end of the calliper on the middle incisor of the upper jaw incisor and the other on the central incisor of the jaw line. Three consecutive measurements were made, with a resting period of 30 seconds between each. The mean of the three measurements was taken as the value for the subsequent analyses. This procedure has proven to have high intra-examiner reliability (ICC=0.90-0.98)
Timepoint [1] 298238 0
AFTER INTERVENTIOn

Eligibility
Key inclusion criteria
(I) older than 25 years old; (II) absence of symptoms in the cervical spine, upper limbs and craniofacial area within the past four weeks previous to data collection; (II) willingness to participate in the study as declared in signing the informed consent form.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(I) a history of whiplash injury;
(II) a history of degenerative disorders of the central and/or peripheral nervous system;
(III) a history of cranial vault, craniofacial, temporomandibular joint, or any level of spinal fractures and/or surgery;
(IV) suffering or having suffered osteitis, or cranial-vault, craniofacial, or temporomandibular joint rheumatic or tumoural diseases; and
(V) consumption of analgesics or anti-inflammatory drugs within 48 hours prior to data collection
(VI) receiving soft tissue therapy within the year before the study

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2012
Actual
16/01/2012
Date of last participant enrolment
Anticipated
Actual
10/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 4396 0
Spain
State/province [1] 4396 0
SEVILLA

Funding & Sponsors
Funding source category [1] 285587 0
University
Name [1] 285587 0
University of Sevilla (Spain)
Country [1] 285587 0
Spain
Primary sponsor type
University
Name
University of Sevilla (Spain)
Address
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.

C/ Avicena s/n 41009 Sevilla (Spain)
Country
Spain
Secondary sponsor category [1] 284419 0
None
Name [1] 284419 0
Address [1] 284419 0
Country [1] 284419 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287594 0
COMITE ETICO DE EXPERIMENTACION DE LA UNIVERSIDAD DE SEVILLA
Ethics committee address [1] 287594 0
Ethics committee country [1] 287594 0
Spain
Date submitted for ethics approval [1] 287594 0
Approval date [1] 287594 0
15/11/2011
Ethics approval number [1] 287594 0
NONE

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34407 0
Dr Alberto Marcos Heredia-Rizo
Address 34407 0
c/ Avicena s/n 41009, Sevilla, University of Sevilla
Country 34407 0
Spain
Phone 34407 0
(+34 954 48 65 07)
Fax 34407 0
Email 34407 0
amheredia@us.es
Contact person for public queries
Name 17654 0
ALBERTO MARCOS HEREDIA RIZO
Address 17654 0
C/ AVICENA S/N

41009 SEVILLA
Country 17654 0
Spain
Phone 17654 0
(+34) 954 48 65 07
Fax 17654 0
(+34) 954 48 65 27
Email 17654 0
amheredia@us.es
Contact person for scientific queries
Name 8582 0
ALBERTO MARCOS HEREDIA RIZO
Address 8582 0
C/ AVICENA S/N

41009 SEVILLA
Country 8582 0
Spain
Phone 8582 0
(+34) 954 48 65 07
Fax 8582 0
(+34) 954 48 65 27
Email 8582 0
amheredia@us.es

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

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