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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12611001108909
Ethics application status
Approved
Date submitted
20/10/2011
Date registered
25/10/2011
Date last updated
3/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of mobilization of the neuraxis in patients with temporomandibular dysfunction.
Scientific title
Effect of central nervous system mobilization versus cervical mobilization on degree of mouth opening in patients with temporomandibular dysfunction
Secondary ID [1] 273243 0
Nil
Universal Trial Number (UTN)
U1111-1125-3325
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular disorders 279004 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279187 279187 0 0
Physiotherapy
Musculoskeletal 279195 279195 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
-Mobilization neurodynamic of the central nervous system by collapse or slump position. Playing with cervical flexion and knee extension and ankle dorsiflexion.
Treatment administered by a physiotherapist.

-1 x 15 minute session per week;

-12 weeks
Intervention code [1] 269577 0
Rehabilitation
Intervention code [2] 269585 0
Treatment: Other
Comparator / control treatment
One control group.

The Active group treatment is only passive motion cervical as it is possible that participants may benefit from this treatment

Treatment administered by a physiotherapist.

1 x 15 minute session per week;

-12 weeks
Control group
Active

Outcomes
Primary outcome [1] 279822 0
Improvement of mouth opening

Is evaluated with digital calipers.
Timepoint [1] 279822 0
3 month
Secondary outcome [1] 294514 0
Improved pain

Is evaluated with "pressure algometer"
Timepoint [1] 294514 0
3 months
Secondary outcome [2] 294530 0
Improved cervical mobility

Is evaluated with goniometry
Timepoint [2] 294530 0
3 months

Eligibility
Key inclusion criteria
Sign an "informed consent" to participate in the study. This document briefly explains the objectives of the study, guaranteeing confidentiality of the data according to the law 15/1999 of Protection of Personal Data.
- Submit a decrease in joint range of the temporomandibular joint in the vertical opening less than 40 mm at the discretion of Maglione.
- Have symptoms of cracking and / or noise in the temporomandibular joint.
- Pain in the facial and masticatory muscles
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Having a chronic rheumatic disease (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis and so on.
- Having had a fracture and / or trauma to the jaw, mandibular condyle, cervical spine, cranial vault or skull base.
- Being pregnant.
- Post-surgical state any surgery three months prior to study participation.
- Submit neurodegenerative diseases.
- Have taken muscle relaxants or anti-inflammatory medication in the last 24 hours.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2012
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] 3915 0
Spain
State/province [1] 3915 0

Funding & Sponsors
Funding source category [1] 270069 0
Self funded/Unfunded
Name [1] 270069 0
JOSE ANTONIO PEREZ MOSCOSO
Country [1] 270069 0
Spain
Primary sponsor type
Individual
Name
ANGEL OLIVA PASCUAL-VACA
Address
University of Sevilla

CALLE SAN FERNANDO 4


SEVILLA (SEVILLA) CP: 41004

SPAIN
Country
Spain
Secondary sponsor category [1] 269035 0
University
Name [1] 269035 0
UNIVERSIDAD DE SEVILLA
Address [1] 269035 0
CALLE SAN FERNANDO 4


SEVILLA (SEVILLA) CP: 41004

SPAIN
Country [1] 269035 0
Spain

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The overall objective of this study is to improve mouth opening in temporomandibular joint mobilization of the neuraxis, and to analyze the additional effects in reducing pain at the level of the masseter, cervical muscles and trigeminal branches and improving the cervical mobility in all three planes of space.

The aim is to check with trigeminal nerve enhancement and nerve trunk there is an increased mobility of the temporomandibular joint and a consequent decrease in pain sensitivity. Using the collapse or slump position for treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33287 0
Address 33287 0
Country 33287 0
Phone 33287 0
Fax 33287 0
Email 33287 0
Contact person for public queries
Name 16534 0
JOSE ANTONIO PEREZ MOSCOSO
Address 16534 0
CALLE ATAHONA NUMBER 4

MEDINA SIDONIA (CADIZ) CP: 11170

SPAIN
Country 16534 0
Spain
Phone 16534 0
+34 605472359
Fax 16534 0
Email 16534 0
[email protected]
Contact person for scientific queries
Name 7462 0
ANGEL OLIVA PASCUAL VACA
Address 7462 0
UNIVERSITY OF SEVILLA

CALLE SAN FERNANDO NUMBER 4

SEVILLA CP: 41004

SPAIN
Country 7462 0
Spain
Phone 7462 0
+34 630254399
Fax 7462 0
Email 7462 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.