Efficacy of Manual Therapy for the Treatment of Migraine. (MT-Migraine)

University of Valencia

Status: Completed

Conditions: Migraine

Treatments: Other: Control group; Other: Manual Therapy based on structural techniques; Other: Manual Therapy based on soft tissues and structural techniques; Other: Manual Therapy based on soft tissues

Study type: Interventional

Funder types: Other

Identifiers

NCT03555214

ID0024

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Manual Therapy based on soft tissue

Experimental group

Treatment:

Other: Manual Therapy based on soft tissues

Control Group

Placebo Comparator group

Treatment:

Other: Control group

Manual Therapy based on structural techniques

Experimental group

Treatment:

Other: Manual Therapy based on structural techniques

Manual Therapy based on soft tissue and structural techniques

Experimental group

Treatment:

Other: Manual Therapy based on soft tissues and structural techniques