Efficacy of Manual Therapy for the Treatment of Migraine.

NCT03555214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-04-14

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555214 on ClinicalTrials.gov