Efficacy of Manual Therapy for the Treatment of Migraine.

NCT03555214 | Completed

• 1 other identifier: ID0024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

migraine; manual therapy

Outcome Measures

Primary Outcomes (1)

• Intensity of Pain

  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".

  8 weeks

Secondary Outcomes (8)

• Disability

  8 weeks

• Health status

  8 weeks

• Headache Impact

  8 weeks

• Depression

  8 weeks

• Change perceived after treatment

  8 weeks

Study Arms (4)

Manual Therapy based on soft tissue

EXPERIMENTAL

Other: Manual Therapy based on soft tissues

Control Group

PLACEBO COMPARATOR

Other: Control group

Manual Therapy based on structural techniques

EXPERIMENTAL

Other: Manual Therapy based on structural techniques

Manual Therapy based on soft tissue and structural techniques

EXPERIMENTAL

Other: Manual Therapy based on soft tissues and structural techniques

Interventions

Manual Therapy based on soft tissues OTHER

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.

Manual Therapy based on soft tissue

Control group OTHER

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.

Control Group

Manual Therapy based on structural techniques OTHER

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.

Manual Therapy based on structural techniques

Manual Therapy based on soft tissues and structural techniques OTHER

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.

Manual Therapy based on soft tissue and structural techniques

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 13, 2018
• Study Start: June 30, 2018
• Primary Completion: October 30, 2018
• Study Completion: December 3, 2019
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

ES (1)