Efficacy of Manual Therapy for the Treatment of Chronic Migraine.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Valencia
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Intensity of Pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Manual Therapy based on soft tissue
Intervention: Manual Therapy based on soft tissues (Other)
Control Group
Intervention: Control group (Other)
Manual Therapy based on structural techniques
Intervention: Manual Therapy based on structural techniques (Other)
Manual Therapy based on soft tissue and structural techniques
Intervention: Manual Therapy based on soft tissues and structural techniques (Other)
Outcomes
Primary Outcomes
Intensity of Pain
Time Frame: 8 weeks
Visual Analog Scale. It is a commonly used and validated instrument in the interpretation of pain intensity. In a line of 10 cm, divided by numbers from 0 to 10, the patient marks the intensity of the pain, being 0 "absence of pain" and 10 "worst pain imaginable".
Secondary Outcomes
- Disability(8 weeks)
- Health status(8 weeks)
- Headache Impact(8 weeks)
- Depression(8 weeks)
- Change perceived after treatment(8 weeks)
- Anxiety(8 weeks)
- Medication intake(8 weeks)
- Migraine Disability(8 weeks)
Investigators
GEMMA V ESPÍ LÓPEZ, PhD
Principal Investigator
University of Valencia