Efficacy of Manual Therapy for the Treatment of Migraine. (MT-Migraine)
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy based on soft tissues
Control group
Manual Therapy based on structural techniques
Manual Therapy based on soft tissues and structural techniques
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring migraine, manual therapy
Eligibility 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.
Sites / Locations
- Faculty of Physiotherapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Manual Therapy based on soft tissue
Control Group
Manual Therapy based on structural techniques
Manual Therapy based on soft tissue and structural techniques
Arm Description
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Disability
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".
Health status
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).
Headache Impact
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".
Depression
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.
Change perceived after treatment
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".
Anxiety
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.
Medication intake
All patients were asked about medication intake
Migraine Disability
Disability caused by migraine was assessed using the Migraine Disability Assessment (MIDAS). On the one hand, it is composed of five questions about lost or less productive days in relation to paid work (questions 1 and 2), housework (questions 3 and 4) and family, social or recreational activities (question 5) due to headaches. The total score is the sum of the days of the 5 questions. On the other hand, it contains 2 clinically relevant questions about headache frequency and pain intensity, . Finally, the score is divided into grade I = 0-5 points, grade II = 6-10 points, grade III = 11-20 points, and grade IV = 21 or more points. In this way, disability is divided into grade I (slight limitations and few treatment needs in patients), grade II (moderate limitations and moderate treatment needs and grades III and IV (serious limitations and great treatment needs).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03555214
Brief Title
Efficacy of Manual Therapy for the Treatment of Migraine.
Acronym
MT-Migraine
Official Title
Efficacy of Manual Therapy for the Treatment of Chronic Migraine.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
December 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Therapy based on soft tissue
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Title
Manual Therapy based on structural techniques
Arm Type
Experimental
Arm Title
Manual Therapy based on soft tissue and structural techniques
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Manual Therapy based on soft tissues
Intervention Description
Manual Therapy:
Technique of suboccipital inhibition.
Cranial frontal technique.
Cranial sphenoid technique.
Cranial fourth ventricle technique.
Antero-posterior abdominal-sacral technique.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy based on structural techniques
Intervention Description
Manual Therapy:
Technique of manipulation of the occipito-atlanto-axoidea joint (OAA).
Articulation technique of the high cervical spine (C0-C1).
Postero-anterior articular technique of C2-C7 in supine position.
Postero-anterior articular technique of C2-C7 in prone position.
Manipulative technique of the flapper C7-T1.
Dorsal spinal manipulative technique (T1-T8).
Lumbosacral global manipulative technique.
Intervention Type
Other
Intervention Name(s)
Manual Therapy based on soft tissues and structural techniques
Intervention Description
Manual Therapy:
Technique of suboccipital inhibition.
Cranial frontal technique.
Cranial sphenoid technique.
Cranial fourth ventricle technique.
Antero-posterior abdominal-sacral technique.
Technique of manipulation of the occipito-atlanto-axoidea joint (OAA).
Articulation technique of the high cervical spine (C0-C1).
Postero-anterior articular technique of C2-C7 in supine position.
Postero-anterior articular technique of C2-C7 in prone position.
Manipulative technique of the flapper C7-T1.
Dorsal spinal manipulative technique (T1-T8).
Lumbosacral global manipulative technique.
Primary Outcome Measure Information:
Title
Intensity of Pain
Description
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".
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Disability
Description
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".
Time Frame
8 weeks
Title
Health status
Description
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).
Time Frame
8 weeks
Title
Headache Impact
Description
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".
Time Frame
8 weeks
Title
Depression
Description
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.
Time Frame
8 weeks
Title
Change perceived after treatment
Description
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".
Time Frame
8 weeks
Title
Anxiety
Description
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.
Time Frame
8 weeks
Title
Medication intake
Description
All patients were asked about medication intake
Time Frame
8 weeks
Title
Migraine Disability
Description
Disability caused by migraine was assessed using the Migraine Disability Assessment (MIDAS). On the one hand, it is composed of five questions about lost or less productive days in relation to paid work (questions 1 and 2), housework (questions 3 and 4) and family, social or recreational activities (question 5) due to headaches. The total score is the sum of the days of the 5 questions. On the other hand, it contains 2 clinically relevant questions about headache frequency and pain intensity, . Finally, the score is divided into grade I = 0-5 points, grade II = 6-10 points, grade III = 11-20 points, and grade IV = 21 or more points. In this way, disability is divided into grade I (slight limitations and few treatment needs in patients), grade II (moderate limitations and moderate treatment needs and grades III and IV (serious limitations and great treatment needs).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Faculty of Physiotherapy
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Manual Therapy for the Treatment of Migraine.
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