Trial Review

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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] 290203 0
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 . 300364 0
mouth opening . 300365 0
Stability
300368 0
Mechanical cervicalgia 301231 0
Condition category
Condition code
Musculoskeletal 300991 300991 0 0
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] 295961 0
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] 299709 0
cervical column mobility measurement in degrees using a goniometer.
Timepoint [1] 299709 0
change between preintervention handling and 30 minutes after the handling.
Secondary outcome [1] 327914 0
Mouth opening using a the digital caliber model C109540 of the mark Medid
Timepoint [1] 327914 0
change between preintervention handling and 30 minutes after the handling.
Secondary outcome [2] 327915 0
Weights distribution left-right in % measured with the baropodometric and stabilometric platform
Timepoint [2] 327915 0
change between preintervention handling and 30 minutes after the handling.
Secondary outcome [3] 330207 0
Average speed in mm/s measured with the baropodometric and stabilometric platform
Timepoint [3] 330207 0
change between preintervention handling and 30 minutes after the handling.
Secondary outcome [4] 330208 0
Maximum and medium pressure point value in grams/cm2 measured with the baropodometric and stabilometric platform
Timepoint [4] 330208 0
change between preintervention handling and 30 minutes after the handling.
Secondary outcome [5] 330209 0
Length of the total displacement in mm measured with the baropodometric and stabilometric platform
Timepoint [5] 330209 0
change between preintervention handling and 30 minutes after the handling.
Secondary outcome [6] 330210 0
Front and back deviation range in mm measured with the baropodometric and stabilometric platform
Timepoint [6] 330210 0
change between preintervention handling and 30 minutes after the handling.
Secondary outcome [7] 330211 0
Side (lateral) deviation range in mm measured with the baropodometric and stabilometric platform
Timepoint [7] 330211 0
change between preintervention handling and 30 minutes after the handling.

Eligibility
Key inclusion criteria
Patients diagnosed with chronic mechanical neck pain
Rotation test in positive cervical flexion
Patients with an age between 18 and 55 years old.
Voluntary Acceptance.
Not complying with any of the exclusion criteria.
Signature of informed consent.
Limitation on opening of mouth less than 4 cm.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People under 18 years and over 55 years.
People with partial or total dental prosthesis.
People with a pathology of the degenerative, inflammatory ,biomechanical, infectious and metabolic type affecting the ATM.
People with column fixing through surgical-orthopedic material.
People with mandibular ATM hyperplasia.
People suffering from traumatic ossifying myositis.
People suffering from hyperthroidism or imperfect osteogenesis.
People suffering or having suffered from pathologies presenting balance disorder ( cerebellar syndrome, tension headaches, migraines, other nervous system disorders, vertigo, dizziness...)
Suffering or having suffered from some type of pathology or disorder of the postural captors that may change the normal postural pattern .
People unable to keep the upright position for more than one minute.
People with some malformation of the skull base or cervical vertebrae.
People having suffered from a recent hard traumatism (car accident, serious bad fall ).
People suffering from a cerebro vascular accident sequels.
People being under medication effects that may interfere with the study results, or having received Ostheopathic treatment within the last two months .
People presenting any disorder, illness or alteration in acute state of the stomatognatic system.
People with oncological diseases (metastatic carcinoma, multiple myeloma, or radiation therapy).
Peolple with pathology affecting the trigeminal nerve: demyelination, neurinoma and hemiplegy.
People suffering or having suffered in the last year from traumatic pathologies of the lower extremities or column, or presenting sequels of these pathologies (lower limbs, backbone, skull fractures).
Inability to follow the study protocol.

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)
The way will be through the randomized.org software.
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The way will be through the randomized.org software.
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 8253 0
Spain
State/province [1] 8253 0
VALENCIA

Funding & Sponsors
Funding source category [1] 294569 0
Self funded/Unfunded
Name [1] 294569 0
JOAQUIN VILLARTA IBANEZ
Country [1] 294569 0
Spain
Primary sponsor type
Individual
Name
JOAQUIN VILLARTA IBANEZ
Address
MARCHALENES 61, 46009, VALENCIA
Country
Spain
Secondary sponsor category [1] 293436 0
None
Name [1] 293436 0
Address [1] 293436 0
Country [1] 293436 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296003 0
COMITE ETICO DE EXPERIMENTACION DE LA SEFO Scientific European Federation of Osteopaths
Ethics committee address [1] 296003 0
Ethics committee country [1] 296003 0
Spain
Date submitted for ethics approval [1] 296003 0
03/10/2016
Approval date [1] 296003 0
Ethics approval number [1] 296003 0

Summary
Brief summary
The posture analysis is a key element in the ostheopathic evaluation of the patient. The posture is determined by the somatosensory ,visual and vestibular levels. The temporomandibular joint and the dental captors, through the trigeminal eferences and afferents, cause significant effects on the posture. Ganggloff et al. mention the trigeminal system influence on the visual and postural control.

An appropriate balance of the chewing, cervical and head musculature seems to be an essential factor in the postural stability, therefore the study will aim to prove if the TNM in maseters in a bilateral way on patients presenting neck pain, a positive cervical flexion test , and a mouth opening limitation, may or may not have an influence on the posture at the patient footstep level as well as at the patient balance level.

This study could point out the need to treat the ATM muscular balance together with the neck area in the case of patients with a short leg and/or disorders of the high cervicals. The study also tries to prove that injuries in the high cervical part and of the ATM may affect the stability of the patients and therefore, this would be an area to check before doing an orthopedic podiatric correction (postural inner soles ).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69222 0
Mr Joaquin Villarta Ibanez
Address 69222 0
Clinic Physiotherapy Fisios Clinica Joaquin Villarta
61 Marchalenes st,
Valencia
46009.
Country 69222 0
Spain
Phone 69222 0
+34609736391
Fax 69222 0
Email 69222 0
joaquin@fisiosclinica.net
Contact person for public queries
Name 69223 0
Joaquin Villarta Ibanez
Address 69223 0
Clinic Physiotherapy Fisios Clinica Joaquin Villarta
61 Marchalenes st.
Valencia
46009.
Country 69223 0
Spain
Phone 69223 0
+34609736391
Fax 69223 0
Email 69223 0
joaquin@fisiosclinica.net
Contact person for scientific queries
Name 69224 0
Joaquin Villarta Ibanez
Address 69224 0
Clinic Physiotherapy Fisios Clinica Joaquin Villarta
61 Marchalenes st.
Valencia
46009.
Country 69224 0
Spain
Phone 69224 0
+34609736391
Fax 69224 0
Email 69224 0
joaquin@fisiosclinica.net

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