Efficacy of Manual Therapy for the Treatment of Migraine. (MT-Migraine)
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|ClinicalTrials.gov Identifier: NCT03555214|
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
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 overall body perception, the change perceived after the treatment, and the frequency of the episodes by means of a weekly record.
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Other: Manual Therapy Group Other: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of Manual Therapy for the Treatment of Chronic Migraine.|
|Actual Study Start Date :||May 31, 2018|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||July 15, 2018|
Experimental: Manual Therapy
Experimental group that will receive combined treatment of soft tissues with techniques evidenced independently.
Other: Control group
Placebo Comparator: Control Group
Grupo control placebo.
Other: Manual Therapy Group
- Pain [ Time Frame: 8 weeks ]Visual Analog Scale
- Frequency of pain [ Time Frame: 8 weeks ]Frequency of pain
- Disability [ Time Frame: 8 weeks ]Headache Disability Inventory (HDI)
- Migraine Dissability [ Time Frame: 8 weeks ]Migraine Dissability Assesment Scale (MIDAS)
- Quality of Life [ Time Frame: 8 weeks ]SF-36
- Headache Impact [ Time Frame: 8 weeks ]Headache Impact Test-6 (HIT-6)
- Depression [ Time Frame: 8 weeks ]Beck Inventory Depression
- Change perceived after treatment [ Time Frame: 8 weeks ]Global Impression Change Scale
- Anxiety [ Time Frame: 8 weeks ]State-Trait Anxiety Inventory (STAI)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555214
|Contact: Gemma V Espí-López, PhD||34963983853 ext firstname.lastname@example.org|
|Contact: Gemma V Espí-López|
|Faculty of Physiotherapy||Recruiting|
|Valencia, Spain, 46010|
|Contact: Gemma V Espí, PhD 34963983853 ext 51307 email@example.com|