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Trial registered on ANZCTR


Registration number
ACTRN12615000698572
Ethics application status
Approved
Date submitted
11/04/2015
Date registered
3/07/2015
Date last updated
8/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of neurodynamics techniques and myofascial soft tissues treatment for tension type headache.
Scientific title
Effectiveness of neurodynamics techniques versus myofascial soft tissues treatment versus both treatment combined compared to a sham treatment for treating tension type headache in 100 subjects.
Secondary ID [1] 286511 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frequent episodic and chronic tension-type headache. 294728 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295017 295017 0 0
Physiotherapy
Musculoskeletal 295699 295699 0 0
Other muscular and skeletal disorders
Neurological 295700 295700 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects who met the inclusion criteria will randomized into 4 groups. Neurodynamics intervention (group 1). Myofascial soft tissue treatment (group 2). Neurodynamics and myofascial soft tissue treatment (group 3). Sham intervention (group 4).
Each group received 6 sessions by a qualified physiotherapist. The sessions distribution was two sessions per week during the first two weeks and one session per week during the last two week. Each session took between 10 and 15 minutes.
Group 1: Neurodinamics techniques with different kinds of mobilization: craniocervical flexion mobilization, cervical lateral glide and jawbone opening. Previous to all the mobilization the shoulder will be depressed and the elbow extended. It takes 10 minutes maximum to complete intervention exercises.
Group 2: Myofascial manual treatment of; sternocleidomastoid, upper trapezius, suboccipitalis, temporal and masseter muscles. Every muscle took two minutes maximum to finish the treatment. It takes 10 minutes maximum to complete intervention exercises.
Group 3: subjects in this group will receive a condensed version of both treatments (the neurodynamics and myofascial techniques specified for Group 1 and 2). It takes 15 minutes maximum to complete intervention exercises.
Intervention code [1] 291604 0
Treatment: Other
Comparator / control treatment
Group 4: subjects in this group will receive a sham treatment which consist in a very soft massage in the mid-thoracic area. 10 minutes
Control group
Placebo

Outcomes
Primary outcome [1] 294771 0
Effectiveness of the treatment protocol. Neurodynamics techniques and/or myofascial soft tissue techniques to reduce tension type headaches related symptoms, was assessed by the use of algometry at supraorbital nerve, masseter and temporal muscle.
Timepoint [1] 294771 0
Baseline, 4 weeks (end of treatment), 2 weeks after the end of treatment and 4 weeks after the end of treatment.
Primary outcome [2] 295408 0
Effectiveness of the treatment protocol. Neuroyinamics techniques and/or myofascial soft tissue techniques to reduce tension type headaches related symptoms, was assessed by the use of Headache impact test questionnaire
Timepoint [2] 295408 0
Baseline, 4 weeks (end of treatment), 2 weeks after the end of treatment and 4 weeks after the end of treatment.
Primary outcome [3] 295409 0
Effectiveness of the treatment protocol. Neurodynamics techniques and/or myofascial soft tissue techniques to reduce tension type headaches related symptoms, was assessed using a headache diary, where they anote the pain perceived every day (three times a day at 09:00, 14:00, 21:00 aprox.) using a 100mm visual analogue scale to calculate intensity and we use this data to calculate the frequency
Timepoint [3] 295409 0
Baseline, 4 weeks (end of treatment), 2 weeks after the end of treatment and 4 weeks after the end of treatment.
Secondary outcome [1] 314016 0
Quality of life in patients was assessed using the Short Form 36
Timepoint [1] 314016 0
Baseline, 4 weeks (end of treatment), 2 weeks after the end of treatment and 4 weeks after the end of treatment.

Eligibility
Key inclusion criteria
Patients with frequent episodic or chronic tension type headache diagnosed according to the criteria of the ICHD-II by an experienced neurologist.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not fulfill the ICHD-II criteria for frequent episodic or chronic tension type headache will be excluded as well as if other primary or secondary headaches criteria are fulfilled.
There will be excluded those patients who can not undergo manual physiotherapy treatment due to biological, metabolic and psychological causes and those that have ever received physical therapy for headache, in order to avoid subjects-expentancy bias.
Those patients who have taken prophylactic medications for headache two month prior to the beginning of the research will be excluded to avoid masking the effects of treatment protocols.

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)
Tension type headache patients diagnosed by a neurologist who meet the inclusion criteria and want to be include in the study.
The allocation to each group was made using central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects who meet the inclusion criteria will be randomized to one of the 4 groups by a computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2014
Actual
23/01/2014
Date of last participant enrolment
Anticipated
Actual
21/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
97
Recruitment outside Australia
Country [1] 6803 0
Spain
State/province [1] 6803 0
Palma de Mallorca

Funding & Sponsors
Funding source category [1] 291079 0
Self funded/Unfunded
Name [1] 291079 0
Country [1] 291079 0
Primary sponsor type
Individual
Name
Alejandro Ferragut Garcias
Address
Ses Alqueries, buzon 26, Santa Eugenia. Balearic Islands. 07142 Spain

Balearic Island University
Country
Spain
Secondary sponsor category [1] 289756 0
None
Name [1] 289756 0
Address [1] 289756 0
Country [1] 289756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292662 0
Comite de Etica de la Investigacion de las Illes Balears (CEI-IB)
Ethics committee address [1] 292662 0
Ethics committee country [1] 292662 0
Spain
Date submitted for ethics approval [1] 292662 0
04/02/2013
Approval date [1] 292662 0
27/02/2013
Ethics approval number [1] 292662 0

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

Contacts
Principal investigator
Name 56438 0
Prof Alejandro Ferragut Garcias
Address 56438 0
Ses Alqueries, Buzon 26. Santa Eugenia, 07142 Balearic Islands
Spain

Facultad de Enfermeria y Fisioterapia de la Universidad de las Islas Baleares
Country 56438 0
Spain
Phone 56438 0
+34 629557418
Fax 56438 0
Email 56438 0
alejandro_sft@yahoo.es
Contact person for public queries
Name 56439 0
Alejandro Ferragut Garcias
Address 56439 0
Ses Alqueries, Buzon 26. Santa Eugenia, 07142 Balearic Islands
Spain

Facultad de Enfermeria y Fisioterapia de la Universidad de las Islas Baleares
Country 56439 0
Spain
Phone 56439 0
+34 629557418
Fax 56439 0
Email 56439 0
alejandro_sft@yahoo.es
Contact person for scientific queries
Name 56440 0
Alejandro Ferragut Garcias
Address 56440 0
Ses Alqueries, Buzon 26. Santa Eugenia, 07142 Balearic Islands
Spain

Facultad de Enfermeria y Fisioterapia de la Universidad de las Islas Baleares
Country 56440 0
Spain
Phone 56440 0
+34 629557418
Fax 56440 0
Email 56440 0
alejandro_sft@yahoo.es

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.