MigraineMT-MigraineNCT03555214
Efficacy of Manual Therapy for the Treatment of Migraine.
A study testing Manual Therapy based on soft tissues, Manual Therapy based on structural techniques and Manual Therapy based on soft tissues and structural techniques in people with Migraine, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine
- What is being tested?
- Manual Therapy based on soft tissues, Manual Therapy based on structural techniques and Manual Therapy based on soft tissues and structural techniques
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2018to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Manual Therapy for the Treatment of Chronic Migraine.
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.
Read more
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
- Being tested
- Manual Therapy based on soft tissues, Control group, Manual Therapy based on structural techniques, Manual Therapy based on soft tissues and structural techniques
- Keywords
- migraine, manual therapy
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy based on soft tissuesOther
Manual Therapy:
- Technique of suboccipital inhibition.
- Cranial frontal technique.
- Cranial sphenoid technique.
- Cranial fourth ventricle technique.
- Antero-posterior abdominal-sacral technique.
Control groupOther
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.
Manual Therapy based on structural techniquesOther
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.
Manual Therapy based on soft tissues and structural techniquesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy based on soft tissue | Experimental | Not described Receives: Other: Manual Therapy based on soft tissues |
| Control Group | Placebo comparator | Not described Receives: Other: Control group |
| Manual Therapy based on structural techniques | Experimental | Not described Receives: Other: Manual Therapy based on structural techniques |
| Manual Therapy based on soft tissue and structural techniques | Experimental | Not described Receives: Other: Manual Therapy based on soft tissues and structural techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 8 weeks
Secondary outcomes (8)
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".
Measured: 8 weeks
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).
Measured: 8 weeks
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".
Measured: 8 weeks
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.
Measured: 8 weeks
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".
Measured: 8 weeks
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.
Measured: 8 weeks
Medication intake
All patients were asked about medication intake
Measured: 8 weeks
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start30 Jun 2018
- Primary completion30 Oct 2018
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555214
- Sponsor's protocol ID
- ID0024
- Acronym
- MT-Migraine
- Status last verified
- Apr 2020
- First submitted
- 31 May 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manual Therapy for the Treatment of Chronic Migraine.
- ClinicalTrials.gov ID
- NCT03555214
- Acronym / sponsor ID
- MT-Migraine / ID0024
- Conditions
- Migraine
- Keywords
- migraine, manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy based on soft tissuesManual 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 | Manual Therapy based on soft tissue |
| Control groupPlacebo 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 | Control Group |
| Manual Therapy based on structural techniquesManual 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 structural techniques |
| Manual Therapy based on soft tissues and structural techniquesManual 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. | Other | Manual Therapy based on soft tissue and structural techniques |
Primary outcome
Intensity of 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".
8 secondary outcomes
Disability
Time frame: 8 weeks
Health status
Time frame: 8 weeks
Headache Impact
Time frame: 8 weeks
Depression
Time frame: 8 weeks
Change perceived after treatment
Time frame: 8 weeks
Anxiety
Time frame: 8 weeks
Medication intake
Time frame: 8 weeks
Migraine Disability
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy based on soft tissues, Manual Therapy based on structural techniques and Manual Therapy based on soft tissues and structural techniques in people with Migraine, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of Pain (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.