Clinical trial NCT03555214: Efficacy of Manual Therapy for the Treatment of Migraine.
Official title: Efficacy of Manual Therapy for the Treatment of Chronic Migraine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine
manual therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Introduction According to the World Health Organization (WHO) at least 47% of adults have suffered from headache in the last year. The headache is not only painful but also disabling, it can be accompanied by social and personal problems, with a decrease in the quality of life and with economic losses. Migraine affects a large number of people and, if the predisposing factors are not controlled, it can become chronic. Once the chronification point of migraine has arrived, it seriously affects the quality of life of people, both in the workplace, social and leisure.

objective Perform the application of a manual therapy treatment based on protocols that include techniques already proven to improve different areas of impact in patients with migraine. To evaluate various aspects, we will include the intensity of pain, the frequency of episodes, anxiety and depression, quality of life, etc ... and the limitations or disability that it produces.

Material and methods This is a prospective, single-blind, randomized study with patients diagnosed with migraine. The sample will be distributed in 4 groups: a) experimental group that will receive combined treatment of soft tissues with techniques evidenced independently; b) Group that will receive independent structural techniques; c) the group that will receive the set of protocols a and b; d) and the placebo control group.

Evaluation An initial assessment will be carried out, another at the end of the treatment and another follow-up one month after the end of the treatment. In addition, the evaluation will include the following instruments: the HDI scale (Headache Disability Inventory), the MIDAS scale (Migraine Disability Assessment Scale), the SF-36 Questionnaire, the EVA Scale (Visual-Analogue Scale), the HIT-6 Questionnaire, the BDI Questionnaire (Beck Inventory Depression), the STAI Questionnaire (The State-Trait Anxiety Inventory), the change perceived after the treatment and medication intake.


Eligibility criteria: Inclusion Criteria:

* Have at least 4 migrainous crises per month, following the criteria established by the IHS
* history of episodes of more than a year of evolution
* use of stable medication during the four weeks prior to the start of the study
* between 18 and 60 years old

Exclusion Criteria:

* currently being in physiotherapy preventive treatment
* being in the process of pharmacological adaptation
* have artery-vertebral involvement problems (bone degeneration, metabolic or musculoskeletal problems that involve vertebral artery risk)
* suffer from dizziness
* suffering dizziness or unbalanced tension.

Primary outcomes:
measure: Intensity of Pain
timeFrame: 8 weeks
Secondary outcomes:
measure: Disability
timeFrame: 8 weeks
measure: Health status
timeFrame: 8 weeks
measure: Headache Impact
timeFrame: 8 weeks
measure: Depression
timeFrame: 8 weeks
measure: Change perceived after treatment
timeFrame: 8 weeks
measure: Anxiety
timeFrame: 8 weeks
measure: Medication intake
timeFrame: 8 weeks
measure: Migraine Disability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy
Study officials:
References: