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Trial registered on ANZCTR

Registration number

ACTRN12617000153314p

Ethics application status

Submitted, not yet approved

Date submitted

12/11/2016

Date registered

27/01/2017

Date last updated

27/01/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Repercussion of the maseters neuromuscular technique in a bilateral. Baropodometric and Stabilometric study.

Scientific title

Repercussion of the maseters neuromuscular technique (TNM) in a bilateral way in patients suffering from chronic mechanical neck pain, and positive neck flexion test. Baropodometric and Stabilometric study.

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1186-9072

Trial acronym

RTNMB

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cervical column mobility .

mouth opening .

Stability

Mechanical cervicalgia

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

MATERIALS:

An electronic Baropodometer with data collection on PC is available to carry out the measurements.
A Baropodometric platform Podoprint of the mark NAMROL, validated by the firm Medicapteurs France SAS in accordance with the annex VI paragraph 3 of the norm 93/42/CEE.

The collection data program is the S-plate 2.3 of the same company.

A digital caliber model C109540 of the mark Medid, CE homologated and with certificate ISO900: 2000 is available to carry out the measurements of the vertical opening of the ATM.

INTERVENTION.

Two practitioners will carry out the study, one will take the measurements, and I will carry out the technique objet of study.

Practitioner 1 (the Evaluator 1 will be a Physiotherapist and Ostheopath C.O. with an experience of 6 years ). She will carry out the first Baropodometric and Stabilometric measurement.
To perform the postural analysis on the platform, there is a large number of studies with different measurement criteria. An A4 Ruhe revision recommends a measurement frequency of 100hz, with a frequency cut of 10hz, with a minimum measurement of 90 seconds, and eyes closed. The Pinsault N.et al, study concludes that after the 3rd measurement carried out on the patient there is a (ICC>0.75) with measurements of 30 seconds should be enough to evaluate the 12 most frequent parameters in the analysis of the move of the pressure center.

The patients positioning will always be the same, the scaphoid tubercle will be placed on the dividing line of the front and back part of the measurement table, the feet will be kept against the positioner , and this will keep the feet separated from the center at the same distance and opened with an angle of 30 degrees . The positioner will be removed and the patient will be asked to look in front of him, at the distance of 1 meter, in which a plomb will be placed at the height of his eyes. We will ask the patient to count from 1 to 10 so many times as needed while the test is being carried out, to keep him constantly awake. The patient will maintain the position during three measurements of 30 seconds each. The arms will adopt the anatomical position.

The practitioner 1 will perform also the atlas rotation-flexion test and the mesurement of the mouth opening with a digital caliber. The patient will be in supine position and the therapist next his head.

The practitioner 2 (Physiotherapist and Ostheopath C.O. with an experience of 11 years ).

The patient will be brought then to the area where then next operation will take place, separated by a room in which practitioner 1 will not be able to watch the performance. The participants will be separated randomly by using the software www.randomize.org into two groups: experimental group and control group.

The maseters bilateral neuromuscular technique in supine positioning as described in accordance with Francois Ricard will be applied to the experimental group.
Technique description: patient in supine position, Ostheopath sitting next to the patient head.Contacts: the contralateral hand will slightly twist the patient head and fix it. The thumb of the homolateral hand will contact the maseter muscle. Technique: the thumb will be moved with a low pressure along the maseter fibers. It is necessary to press along the spasm fibers, trough the trigger point.

The same contacts will be applied to the control group, but without any performance.

The patient will go back to room 1, so that the practitioner 1 (without knowing which performance has been applied) carries out the post-intervention measurements. The evaluator is blinded.
The technique application takes five minutes.

LOCATION.

The recruitement will take place at the following center, of which I am the owner:
Centro de FIsioterapia Fisio' s Clinica Joaquin
61 Marchalenes street
46009 Valencia
Spain.

Intervention code [1]

Rehabilitation

Comparator / control treatment

GROUPS:

Depending on the sample size obtained, it will be divided through the randomized.org software into two equal groups with a minimum of 30 people in each.

TREATMENT:
The experimental group will be treated with the neuromuscular maseters technique in a bilateral way in supine as described by Francois Ricard.
The control group will be treated with the same contacts, but without carrying out any kind of manouvre or handling.

Control group

Placebo

Outcomes

Primary outcome [1]

cervical column mobility measurement in degrees using a goniometer.

Timepoint [1]