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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?
Scientific title
Influence of myofascial treatment of trigger points on pressure point tenderness and temperomandibular joint range of motion in episodic tension-type headache
Secondary ID [1] 301856 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
episodic tension-type headache 318350 0
temporomandibular disorders 318351 0
Condition category
Condition code
Physical Medicine / Rehabilitation 316357 316357 0 0
Physiotherapy
Musculoskeletal 319242 319242 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 318147 0
Rehabilitation
Intervention code [2] 320210 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 324521 0
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).
Timepoint [1] 324521 0
Baseline and 3 weeks post-intervention
Primary outcome [2] 327115 0
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,
Timepoint [2] 327115 0
Baseline and 3 weeks post-intervention
Primary outcome [3] 328354 0
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.
Timepoint [3] 328354 0
Baseline and 3 weeks post-intervention
Secondary outcome [1] 384881 0
Quality of life measured using SF36 questionnaire
Timepoint [1] 384881 0
Baseline and 3 weeks post-intervention
Secondary outcome [2] 393852 0
jaw overuse behaviors (awake and slept) assessed using the Oral Behaviours Checklist
Timepoint [2] 393852 0
Baseline and 3 weeks post-intervention

Eligibility
Key inclusion criteria
People with episodic tension-type headache
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pathologies with contraindication to manual therapy

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 22785 0
Spain
State/province [1] 22785 0

Funding & Sponsors
Funding source category [1] 306279 0
Self funded/Unfunded
Name [1] 306279 0
Ada M. González-González
Country [1] 306279 0
Spain
Primary sponsor type
Individual
Name
Ada M. González-González
Address
Miss Ada M. González-González
Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Spain
Country
Spain
Secondary sponsor category [1] 306770 0
None
Name [1] 306770 0
None
Address [1] 306770 0
None
Country [1] 306770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306495 0
Fundación ASPAYM Castilla y León
Ethics committee address [1] 306495 0
Ethics committee country [1] 306495 0
Spain
Date submitted for ethics approval [1] 306495 0
Approval date [1] 306495 0
20/11/2019
Ethics approval number [1] 306495 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104062 0
Miss Ada M. González-González
Address 104062 0
Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Spain
Country 104062 0
Spain
Phone 104062 0
+34610947059
Fax 104062 0
Email 104062 0
[email protected]
Contact person for public queries
Name 104063 0
Ada M. González-González
Address 104063 0
Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Spain
Country 104063 0
Spain
Phone 104063 0
+34610947059
Fax 104063 0
Email 104063 0
[email protected]
Contact person for scientific queries
Name 104064 0
Ada M. González-González
Address 104064 0
Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Spain
Country 104064 0
Spain
Phone 104064 0
+34610947059
Fax 104064 0
Email 104064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is not possible due to our Data Protection Law.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo 1. Research question: Is myofascial treatment of t... [More Details]

Documents added automatically
No additional documents have been identified.