ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03555214
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

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 overall body perception, the change perceived after the treatment, and the frequency of the episodes by means of a weekly record.


Condition or disease Intervention/treatment Phase
Migraine Other: Manual Therapy Group Other: Control group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Manual Therapy for the Treatment of Chronic Migraine.
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Manual Therapy
Experimental group that will receive combined treatment of soft tissues with techniques evidenced independently.
Other: Control group
Placebo treatment

Placebo Comparator: Control Group
Grupo control placebo.
Other: Manual Therapy Group

Manual Therapy:

  1. Technique of suboccipital inhibition.
  2. Technique of decompression of the lumbosacral hinge.
  3. Decompression technique of sphenobasilar synchondrosis.
  4. Fourth ventricle technique.
  5. Technique of lifting the front.




Primary Outcome Measures :
  1. 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".

  2. Frequency of pain [ Time Frame: 8 weeks ]
    The frequency will be registered by a weekly record.


Secondary Outcome Measures :
  1. Disability [ Time Frame: 8 weeks ]
    Headache Disability Inventory (HDI). Questionnaire developed by G.P. Jacobson et al. to quantify the impact of disability due to headache in daily life. The objective is to identify the difficulties that the patient experiences due to headaches. It consists of two questions: 1) intensity of pain (mild, moderate and severe), and 2) frequency (once a month, more than 1 and less than 4 times a month, and once a week). In addition, it includes 25 items with two subscales, one emotional (13 items) and another functional (12 items) with three possible answers ("no" 0 points, "sometimes" 2 points, "yes" 4 points). The maximum score is 100 points, with 0 "no disability" and 100 "maximum disability".

  2. Quality of Life [ Time Frame: 8 weeks ]
    SF-36. It consists of 36 items with the following scales: Physical function (items 3a, 3b, 3c, 3d, 3e, 3f, 3g, 3h, 3i, 3j), Physical role (items 4a, 4b, 4c, 4d), Corporal pain ( items 7, 8), General Health (items 1, 11a, 11b, 11c, 11d), Vitality (items 9a, 9e, 9g, 9i), Social function (items 6, 10), Emotional role (items 5a, 5b, 5c) and Mental Health (items 9b, 9c, 9d, 9f, 9h). Includes an item on the change in the general health status with respect to the previous year (item 2). To calculate the score, we must first homogenize the address of the answers by re-coding the items that require it, so that "the higher the score, the better the health condition", then the calculation of the sum of the items of each scale and, finally, the linear transformation of raw scores on a scale of 0 (worst health status for that dimension) to 100 (the best health status).

  3. Headache Impact [ Time Frame: 8 weeks ]
    Headache Impact Test-6 (HIT-6). Published by Ware et al. To measure the impact of headache. The score is calculated as follows: never (6 points), few times (8 points), sometimes (10 points), very often (11 points) and always (13 points). With a total of 49 or less points is considered "little or no impact", between 50-55 "some impact", between 56-59 "significant impact" and 60 or more "very severe impact".

  4. Depression [ Time Frame: 8 weeks ]
    Beck Inventory Depression. It is a questionnaire used to measure the severity of depression in adolescents and adults. Published by Beck et al. And reviewed in 1996,1 questions that include a cognitive-affective factor and a somatic-motivational factor, collecting symptoms such as hopelessness, irritability, dissatisfaction with oneself, changes in the sleep pattern, loss of energy, difficulty of concentration and fatigue-fatigue. In 1972, Beck et al. they developed the short form with 13 items. Each item is valued from 0 to 3, with a total score of 39. The cut-off points recommended by the American Psychiatric Association are: 0-4 absent or minimal, 5-7 mild, 8-15 moderate,> 15 severe.

  5. Change perceived after treatment [ Time Frame: 8 weeks ]
    Global Impression Change Scale. To assess the change perceived after the treatment, patients are asked to rate their perception of change in the Global Impression Change Scale of the patient, and a questionnaire with a question and 7 alternatives, being 1 "maximum change" and 7 "Nothing of change".

  6. Anxiety [ Time Frame: 8 weeks ]

    State-Trait Anxiety Inventory (STAI). Questionnaire developed by Spielberger et al.1 showed that it is the seventh most used questionnaire in Spain.

    It consists of 40 items and they are valued on Likert scales of four points. It is divided into two sections: anxiety-state (items 1 to 20) and anxiety-trait (items 21 to 40); the first in relation to an emotional state that can vary in intensity over time, and the second, measures the tendency to anxiety and to perceive situations as threatening. As a result, a score <30 indicates a low level of anxiety, between 30 and 44 points, average anxiety level, and> 44 points, high anxiety level.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555214


Contacts
Contact: Gemma V Espí-López, PhD 34963983853 ext 83853 gemma.espi@uv.es
Contact: Gemma V Espí-López

Locations
Spain
Faculty of Physiotherapy Recruiting
Valencia, Spain, 46010
Contact: Gemma V Espí, PhD    34963983853 ext 51307    gemma.espi@uv.es   
Sponsors and Collaborators
University of Valencia

Responsible Party: GEMMA V ESPÍ LÓPEZ, PhD, Principal Investigator, University of Valencia
ClinicalTrials.gov Identifier: NCT03555214     History of Changes
Other Study ID Numbers: ID0024
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia:
migraine
manual therapy

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases