Efficacy of Manual Therapy for the Treatment of Migraine.
NCT03555214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2020-04-14
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.
Conditions
Interventions
- OTHER
-
Manual Therapy based on soft tissues
Manual Therapy: 1. Technique of suboccipital inhibition. 2. Cranial frontal technique. 3. Cranial sphenoid technique. 4. Cranial fourth ventricle technique. 5. Antero-posterior abdominal-sacral technique.
- OTHER
-
Control group
Placebo treatment: The patient remains supine and the therapist sits on a stool at the bedside with the forearms resting on the couch. Both hands are placed on the posterolateral part of the patient's head and the position is maintained for 10 minutes without exerting any force or movement.
- OTHER
-
Manual Therapy based on structural techniques
Manual Therapy: 1. Technique of manipulation of the occipito-atlanto-axoidea joint (OAA). 2. Articulation technique of the high cervical spine (C0-C1). 3. Postero-anterior articular technique of C2-C7 in supine position. 4. Postero-anterior articular technique of C2-C7 in prone position. 5. Manipulative technique of the flapper C7-T1. 6. Dorsal spinal manipulative technique (T1-T8). 7. Lumbosacral global manipulative technique.
- OTHER
-
Manual Therapy based on soft tissues and structural techniques
Manual Therapy: 1. Technique of suboccipital inhibition. 2. Cranial frontal technique. 3. Cranial sphenoid technique. 4. Cranial fourth ventricle technique. 5. Antero-posterior abdominal-sacral technique. 6. Technique of manipulation of the occipito-atlanto-axoidea joint (OAA). 7. Articulation technique of the high cervical spine (C0-C1). 8. Postero-anterior articular technique of C2-C7 in supine position. 9. Postero-anterior articular technique of C2-C7 in prone position. 10. Manipulative technique of the flapper C7-T1. 11. Dorsal spinal manipulative technique (T1-T8). 12. Lumbosacral global manipulative technique.
Sponsors & Collaborators
-
University of Valencia
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-30
- Primary Completion
- 2018-10-30
- Completion
- 2019-12-03
Countries
- Spain
Study Locations
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