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Trial registered on ANZCTR


Registration number
ACTRN12622000746730
Ethics application status
Approved
Date submitted
6/01/2022
Date registered
24/05/2022
Date last updated
4/10/2022
Date data sharing statement initially provided
24/05/2022
Date results information initially provided
4/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a strength training program on muscle cross-sectional area (CSA) and pain in people with chronic tension-type headache
Scientific title

The effect of a 12-week strength training program on muscle cross-sectional area (CSA) and pain in adults with chronic tension-type headache
Secondary ID [1] 306102 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
migraine 324767 0
tensional type headache 324768 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322218 322218 0 0
Physiotherapy
Neurological 322599 322599 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
arm 1: Strength training program. developed by an expert physical therapist (PT) with more than 20 years of experience in the field.
theraband with a resistance in accordance to their strength level was delivered to the intervention group participants (looking for a 7/10 Borg scale)
12 week intervention program. Participants must complete two training sessions (with at least one day rest between sessions) per week. after the first 4 weeks they can advance to 3 days per week if they feel capable and with the PT permission as part of the training progression (1 day rest in between training sessions always).
the exercises will be first explained by the expert and then perform supervised by the same expert. afterwards and with the permission of the expert they can do the training program at home. A video with the expert doing the exercises will be delivered to the training group so the can follow the training session watching the expert doing the exercises

exercises; conventional warm up, consisting in mobility and activation exercises will be always perform before the strength training session.
Training session:
3 sets of 10 repetitions (6 seconds of isometric contraction each rep). Intensity 70% of the maximum voluntary contraction (MVC) for neck movements:inclinations, rotations, flexion and extension for a total of 6 neck exercises.
3 sets of 8repetitions. Intensity 70% of the 1 repetition maximum (RM), (7/10 RPE) for shoulder upper body exercises. 5 exercises in total

everybody will perform at least 28 training session in 12 weeks

Each session will last around 25 minutes including the warm up
Intervention code [1] 322513 0
Rehabilitation
Intervention code [2] 322810 0
Treatment: Other
Comparator / control treatment
The control group will not receive any treatment and will also undergo outcome assessments for comparison.
Control group
Active

Outcomes
Primary outcome [1] 329980 0
The VAS pain scale (0-100) will be used as primary outcome
Timepoint [1] 329980 0
12-14 weeks after the pre intervention measures
Primary outcome [2] 329981 0
Pain duration measured as hours of pain per day. and days per month registered on a pain diary designed for this purpose will be used as primary outcome
Timepoint [2] 329981 0
12-14 weeks after the pre intervention measures
Primary outcome [3] 329982 0
Headache impact assessed using the HIT-6 questionnaire will be a primary outcome
Timepoint [3] 329982 0
It will remeasured 12-14 weeks after the pre-intervention measures
Secondary outcome [1] 404510 0
cross sectional area of the longissimus capitis will be measured with ultrasound image
Timepoint [1] 404510 0
it will be remeasured 12-14 weeks after the pre intervention measures
Secondary outcome [2] 407600 0
Pain threshold to pressure will be measured with an algometer

Timepoint [2] 407600 0
it will be remeasured 12-14 weeks after the pre intervention measures
Secondary outcome [3] 409076 0
cross sectional area of the multifidus muscles at the neck will be measured with ultrasound image
Timepoint [3] 409076 0
it will be remeasured 12-14 weeks after the pre intervention measures
Secondary outcome [4] 409695 0
Headache impact assessed using the MIDAS questionnaire will be use as a primary outcome of this study. This outcome is primary
Timepoint [4] 409695 0
It will be remeasured 12-14 weeks after the pre intervention measures

Eligibility
Key inclusion criteria
The patients recruited will present a history of at least 6 months of chronic tension-type headache
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that are pregnant or have an intention to start other therapies during th 12 weeks intervention will not be recruited. Also patients that present a contraindication to perform physical activity will also be excluded.

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 allocation of the patients in two different groups will be done with sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
The calculation of the sample size was carried out with the GRANMO 7.12c software for scoring the Headache Impact Test-6 (HIT-6) for its ability to evaluate the effect of headache on activities of daily living of patients and due to its relationship with key aspects of symptoms, such as headache severity and quality of life.. A level of .05 and a desired power (b) of 80% with bilateral contrast were assumed. These assumptions generated a sample size of at least 23 participants per group to detect a minimum difference of 6 and a SD of 5.52. Loss to follow-up was estimated at 15%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/06/2022
Date of last participant enrolment
Anticipated
Actual
24/06/2022
Date of last data collection
Anticipated
Actual
23/09/2022
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24458 0
Spain
State/province [1] 24458 0
MADRID

Funding & Sponsors
Funding source category [1] 310445 0
Self funded/Unfunded
Name [1] 310445 0
Country [1] 310445 0
Primary sponsor type
University
Name
UNIVERSITY EUROPEA OF MADRID
Address
C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
Country
Spain
Secondary sponsor category [1] 311600 0
None
Name [1] 311600 0
Address [1] 311600 0
Country [1] 311600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310084 0
UNIVERSITY REY JUAN CARLOS
Ethics committee address [1] 310084 0
C. Tulipán, s/n, 28933 Móstoles, Madrid
Ethics committee country [1] 310084 0
Spain
Date submitted for ethics approval [1] 310084 0
01/03/2021
Approval date [1] 310084 0
31/03/2021
Ethics approval number [1] 310084 0
1802202105721

Summary
Brief summary
There is scientific evidence showing how muscle pain is associated with a loss of strength and motor control. In this sense, it is conceivable that this loss of strength could be related to changes in the thickness of the cervical muscles, as confirmed by some studies.
The main hypothesis of this study is that the improvement of the neck muscle strength reduces the pain in this type of patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116426 0
Dr Jose Angel Del Blanco Muñiz
Address 116426 0
GRUPO INVESTIGACIÓN EJERCICIO TERAPÉUTICO Y REHABILITACIÓN FUNCIONAL
DEPARTAMENTO DE FISIOTERAPIA
C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
Country 116426 0
Spain
Phone 116426 0
+34 654320693
Fax 116426 0
Email 116426 0
JOSEANGEL.DELBLANCO@universidadeuropea.es
Contact person for public queries
Name 116427 0
Dr Alberto Sánchez Sierra
Address 116427 0

GRUPO INVESTIGACIÓN EJERCICIO TERAPÉUTICO Y REHABILITACIÓN FUNCIONAL DEPARTAMENTO DE FISIOTERAPIA C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid.
C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
Country 116427 0
Spain
Phone 116427 0
+34 608801238
Fax 116427 0
Email 116427 0
alberto.sanchez@universidadeuropea.es
Contact person for scientific queries
Name 116428 0
Dr Alberto Sánchez Sierra
Address 116428 0

GRUPO INVESTIGACIÓN EJERCICIO TERAPÉUTICO Y REHABILITACIÓN FUNCIONAL DEPARTAMENTO DE FISIOTERAPIA C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
Country 116428 0
Spain
Phone 116428 0
+34 608801238
Fax 116428 0
Email 116428 0
alberto.sanchez@universidadeuropea.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The main outcomes data that will be shared are the cross sectional area of the muscles measured, the values of the pain threshold measured with an algometer, and the results of the questionaire HIT-6 plus the data collected from the days and hours of pain and VAS values
When will data be available (start and end dates)?
it will be available after the article publication and with no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
By emailing one of the investigators (Alberto ) using the following email: Alberto.sanchez@universidadeuropea.es


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14514Ethical approval  alberto.sanchez@universidadeuropea.es 383342-(Uploaded-22-12-2021-09-56-06)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The entire study has not been completed yet. Altho... [More Details]

Documents added automatically
No additional documents have been identified.