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Trial registered on ANZCTR
Registration number
ACTRN12621001472864
Ethics application status
Approved
Date submitted
22/07/2020
Date registered
28/10/2021
Date last updated
28/10/2021
Date data sharing statement initially provided
28/10/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Is temporal muscle treatment useful in episodic tension-type headache?
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Scientific title
Influence of myofascial treatment of trigger points on pressure point tenderness and temperomandibular joint range of motion in episodic tension-type headache
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Secondary ID [1]
301856
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
episodic tension-type headache
318350
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temporomandibular disorders
318351
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Condition category
Condition code
Physical Medicine / Rehabilitation
316357
316357
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0
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Physiotherapy
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Musculoskeletal
319242
319242
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
We have many patients with tension-type headache. We are studying the relationship between the temporomandibular joint (TMJ) an the episodic tension-type headache. We have the approval of an ethics committee to apply myofascial therapy in our experimental group and a sham therapy in our control group. Patients would be blind to treatment, as well as evaluators. The intervention will last 3 weeks (20 minute per session, one session per week). Treatment consists on pressuring the four myofascial trigger point of the temporalis muscle using an algometer. The same physiotherapist will treat all patients in a physiotherapy clinic. So our independent variables are group and time. Our dependent variables are: algometry in different trigger points, range of movement of neck muscles and TMJ, the SF36 (Health questionnaire), and Check Oral Behavioral List.
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Intervention code [1]
318147
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Rehabilitation
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Intervention code [2]
320210
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Treatment: Other
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Comparator / control treatment
Control group receives a sham treatment that consists on a placebo pressure applied by a physiotherapist on the same four temporalis trigger points using an algometer. The difference in respect to the intervention group lay in the pressure exerted, The pressure consists of supporting the algometer during 60 second in each one of the 4 trigger points of the temporal muscle. A 30 seconds rest period is used between pressures. Treatment is applied bilaleraly.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Algometry in different muscle trigger points (TP): Temporal (4 TP), Masseter (3 TP), Digastric (2 TP), Masseter (3 TP), Trapezius (2 TP), Trapezius (2 TP), Levator scapulae (1 TP), Head semispinosus (2TP), sternocleidomastoid (2TP) and obliquus capitis superior (2TP).
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Assessment method [1]
324521
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Timepoint [1]
324521
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Baseline and 3 weeks post-intervention
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Primary outcome [2]
327115
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Range of movement of neck muscles: neck flexion, extension, left rotation, right rotation, left inclination and right inclination. All range of motions will be measured with a goniometer,
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Assessment method [2]
327115
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Timepoint [2]
327115
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Baseline and 3 weeks post-intervention
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Primary outcome [3]
328354
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Range of movement of TMJ: mouth opening, mouth maximum opening, protraction, left lateralization and right lateralization. This range of motion will be measured with a Therabite.
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Assessment method [3]
328354
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Timepoint [3]
328354
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Baseline and 3 weeks post-intervention
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Secondary outcome [1]
384881
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Quality of life measured using SF36 questionnaire
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Assessment method [1]
384881
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Timepoint [1]
384881
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Baseline and 3 weeks post-intervention
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Secondary outcome [2]
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jaw overuse behaviors (awake and slept) assessed using the Oral Behaviours Checklist
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Assessment method [2]
393852
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Timepoint [2]
393852
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Baseline and 3 weeks post-intervention
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Eligibility
Key inclusion criteria
People with episodic tension-type headache
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Pathologies with contraindication to manual therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
27/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
20
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Final
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Recruitment outside Australia
Country [1]
22785
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Spain
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State/province [1]
22785
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Funding & Sponsors
Funding source category [1]
306279
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Self funded/Unfunded
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Name [1]
306279
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Ada M. González-González
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Address [1]
306279
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Miss Ada M. González-González
Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Spain
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Country [1]
306279
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Spain
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Primary sponsor type
Individual
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Name
Ada M. González-González
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Address
Miss Ada M. González-González
Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Spain
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Country
Spain
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Secondary sponsor category [1]
306770
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None
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Name [1]
306770
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None
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Address [1]
306770
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None
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Country [1]
306770
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306495
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Fundación ASPAYM Castilla y León
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Ethics committee address [1]
306495
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Ethics Committee belonging to the Fundación ASPAYM Castilla y León
c/Treviño, 74
CP: 47008
Valladolid, Spain
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Ethics committee country [1]
306495
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Spain
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Date submitted for ethics approval [1]
306495
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Approval date [1]
306495
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20/11/2019
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Ethics approval number [1]
306495
0
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Summary
Brief summary
The aim of this study is to analyze the influence of temporalis myofascial trigger point treatment in patients with episodic tension-type headache. We hypothesize that the intervention groups will have a greater range of motion and greater tolerance to pressure after the experimental period. Two groups of 15 patients will be created: interventions and control groups. Interventions will last 3 weeks (1 intervention/week) and will consists on the myofaccial treatment of temporalis trigger points by a physiotherapist. Control groups will receive a placebo treatment. Before and after treatment the following outcomes will be measured: algometry in different muscle trigger points (TP): Temporal (4 TP), Masseter (3 TP), Digastric (2 TP), Masseter (3 TP), Trapezius (2 TP), Trapezius (2 TP), Levator scapulae (1 TP), Head semispinosus (2TP), sternocleidomastoid (2TP) and obliquus capitis superior (2TP); range of movement of neck muscles: neck flexion, extension, left rotation, right rotation, left inclination and right inclination; range of movement of TMJ: mouth opening, mouth maximum opening, protraction, left lateralization and right lateralization; SF36 (Health questionnaire); and Check Oral Behavioral List.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Ada M. González-González
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Address
104062
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Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Spain
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Country
104062
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Spain
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Phone
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+34610947059
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Fax
104062
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Email
104062
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[email protected]
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Contact person for public queries
Name
104063
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Mrs Ada M. González-González
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Address
104063
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Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Spain
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Country
104063
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Spain
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Phone
104063
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+34610947059
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Fax
104063
0
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Email
104063
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[email protected]
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Contact person for scientific queries
Name
104064
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Mrs Ada M. González-González
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Address
104064
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Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Spain
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Country
104064
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Spain
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Phone
104064
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+34610947059
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Fax
104064
0
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Email
104064
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
It is not possible due to our Data Protection Law.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4151
Plain language summary
No
1. Research question: Is myofascial treatment of t...
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