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Trial registered on ANZCTR


Registration number
ACTRN12616001327471
Ethics application status
Approved
Date submitted
12/01/2016
Date registered
22/09/2016
Date last updated
22/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of combined treatment on cervical spine and masticatory muscles on temporomandibular disorders. A pilot study.
Scientific title
Effectiveness of combined treatment on cervical spine and masticatory muscles on temporomandibular disorders. A Randomized Controlled Trial.
Secondary ID [1] 288283 0
None
Universal Trial Number (UTN)
None
Trial acronym
.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular disorders 297243 0
Condition category
Condition code
Musculoskeletal 297449 297449 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298187 298187 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this trial, patients with Temporomandibular Disorders are randomly assigned to one of four groups (three of them are treatment, and the other one is placebo). The first treatment group receives postero-anterior slow mobilizations in high cervical spine (C2) in four sets of 45 seconds each, with 15 seconds rest in between each set. The second one receives dry-needling in masseter muscle until the patient tolerates or during 60 seconds maximum. The third one receives both treatments. The treatments were administrated by two accredited physiotherapists with 2 and 5 years of experience.
The treatment is based in two sessions spaced two weeks apart. Prior to each treatment session, pain intensity (Visual Analog Scale), pressure sensitivity (with Algometer) and maximum mouth opening (mm interincisor distance) are measured. Furthermore, there is a follow-up assessment, four weeks after last treatment session, with the same variable measurement. To monitor the adherence to the intervention, it is checked at each session that all the patients have attended.
Intervention code [1] 293576 0
Rehabilitation
Comparator / control treatment
The comparator group has the same number of patients and receives the same number of treatment sessions and follow-up assessments. The placebo administrated in this comparator group is fake dry-needling in the masseter muscle during 60 seconds maximum.
Control group
Placebo

Outcomes
Primary outcome [1] 297007 0
The primary outcome is pain assessed by visual analogue scale.
Timepoint [1] 297007 0
Immediately prior to first session, at second session (2 weeks after first session), and at third session (one month after second session).
Secondary outcome [1] 319835 0
The secondary outcome is mouth opening, measured using measuring tape by treating physiotherapist.
Timepoint [1] 319835 0
Immediately prior to first session, at second session (2 weeks after first session), and at third session (one month after second session).
Secondary outcome [2] 319836 0
Pressure sensibility, assessed using mechanical algometer.
Timepoint [2] 319836 0
Immediately prior to first session, at second session (2 weeks after first session), and at third session (one month after second session).

Eligibility
Key inclusion criteria
Patients diagnosed with temporomandibular disorder.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with presence of other pathologies than musculoskeletal, either genetic (Down syndrome, etc.) or neurological (ICTUS, etc.). Patients that have not been treated by dry needling any time before.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using table created by a computer software (Epidat).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/02/2016
Date of last participant enrolment
Anticipated
Actual
31/07/2016
Date of last data collection
Anticipated
Actual
9/09/2016
Sample size
Target
60
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 7507 0
Spain
State/province [1] 7507 0
Madrid

Funding & Sponsors
Funding source category [1] 292662 0
University
Name [1] 292662 0
Universidad Alcala de Henares
Country [1] 292662 0
Spain
Primary sponsor type
University
Name
Universidad Alcala de Henares
Address
Plaza de San Diego, s/n,28801 Alcala de Henares,Madrid
Country
Spain
Secondary sponsor category [1] 291380 0
None
Name [1] 291380 0
None
Address [1] 291380 0
None
Country [1] 291380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294132 0
Comite de Etica de la Investigacion y de Experimentacion animal de la Universidad Alcala de Henares
Ethics committee address [1] 294132 0
Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid
Ethics committee country [1] 294132 0
Spain
Date submitted for ethics approval [1] 294132 0
23/11/2015
Approval date [1] 294132 0
23/11/2015
Ethics approval number [1] 294132 0

Summary
Brief summary
The aim of this study is to prove that a combined treatment with postero-anterior mobilisations in the high cervical spine and dry needling in masseter muscles is better than this two therapies on their own in patients with temporomandibular disorders diagnosed. The secondary aims are to improve the pain, the mouth opening and the pressure sensibility.

It is a Randomized Controlled Trial with blinded evaluator in which the study population are adults between 20 and 50 years old. Patients will be divided in four groups, one control and three experimental groups. In the control group fake dry needling will be apply in masseter muscle. In the experimental group 1, the treatment will be postero-anterior mobilisations in high cervical spine. The experimental group 2, will receive dry needling in masseter muscle. And the experimental group 3, will receive both, mobilisations and dry needling, treatments.

The work plan will be distributed in the next way:
First evaluation before the first treatment session.
Second evaluation and second session two weeks later from the first one.
Third and last evaluation. This is a control evaluation one month later than the last treatment session.
In all the evaluation the patients will be identified as a number, so the evaluator will not know which patient belongs to one experimental group and which one to the control group.

After the data collection, these will be analysed by the SPSS 17.0 program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62638 0
Miss Pilar Moreu Peso
Address 62638 0
Plaza de San Diego, s/n,28801 Alcala de Henares,Madrid, University of Alcala de Henares.
Country 62638 0
Spain
Phone 62638 0
+34 600 63 23 91
Fax 62638 0
Email 62638 0
[email protected]
Contact person for public queries
Name 62639 0
Sandra García Valero
Address 62639 0
Plaza de San Diego, s/n,28801 Alcala de Henares, University of Alcala de Henares
Country 62639 0
Spain
Phone 62639 0
+34 687 72 20 01
Fax 62639 0
Email 62639 0
[email protected]
Contact person for scientific queries
Name 62640 0
Guillermo Gil Palop
Address 62640 0
Plaza de San Diego, s/n,28801 Alcala de Henares,Madrid, University of Alcala de Henares.
Country 62640 0
Spain
Phone 62640 0
+34 651 40 63 99
Fax 62640 0
Email 62640 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

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