Migraine Disorders
Conditions
Keywords
physical therapy, transcranial direct current stimulation, facial recognition
Brief summary
The aim of this clinical study is to compare the effects of tDCS, physiotherapy, and their association with the intensity in women with Chronic Migraine. For this purpose, the patients included in the study will be distributed among four groups following a factorial model.
Detailed description
A factorial, randomized clinical trial will be conducted to evaluate pain control, the number of migraine attacks, quality of life, emotional dysfunctions, and attentional processing of migraine patients. Clinical outcomes will be evaluated through (I) a Visual Analog Scale (VAS); (II) pressure pain threshold; (III) a Headache Impact Test (HIT-6); (IV) a Migraine Disability Assessment (MIDAS); (V) Short-Form Health Survey Questionnaire de 36 items (SF-36); (VI) Patients' Global Impression of Change Scale (PGICS); (VII) Beck Depression Inventory (BDI); (VIII) State-Trait Anxiety Inventory (S-TAI); (IX) Perceived Stress Scale (PSS); and (X) Facial Expression Database.
Interventions
DEVICEactive tDCS
The electrode will measure 5x5 cm and a current of 2mA will be applied for 20 minutes. The current density will be 0.08mA/cm². tDCS will be applied three times a week for 20 minutes over four weeks.
DEVICEsham tDCS
The electrode will measure 5x5 cm. The sham-type current will show a rising ramp where the initial 30 seconds will be real current with the same parameter as the active group. After this time, the current will be automatically stopped by the device. tDCS will be applied three times a week for 20 minutes over four weeks.
OTHERreal Physical Therapy
Manual maneuvers and therapeutic exercises will be performed for 30 minutes, three times a week over four weeks.
OTHERplacebo Physical Therapy
The placebo Physical Therapy will be applied for 30 minutes, three times a week over four weeks. The initial 20 minutes will be used for the application of simulated ultrasound bilaterally in the middle portion of the upper trapezius muscle. In the final 10 minutes, the researcher will place the palms of the hand under the occipital region without applying any force or movement with the participant in the supine position.
Sponsors
Federal University of Paraíba
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be randomized into four intervention groups: transcranial Direct Current Stimulation + Physical Therapy Group (tDCS active + PT active), tDCS group (tDCS active + PT placebo), PT group (tDCS sham + PT active), control group (tDCS sham + PT placebo ).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women; * 18-50 years old; * with Chronic Migraine according to ICHD-3 beta; * literate; * stable on routine medications specific for MC for at least 2 months, who were not undergoing other types of non-pharmacological interventions for MC, not lactating or pregnant, without neurological diseases or serious neuropsychiatric diseases, without other types of associated headaches, without signs and/or symptoms of spinal radiculopathy, without metal implants located in the head and/or cochlear implants.
Exclusion criteria
* who perhaps become pregnant during the execution of the clinical trial * present some disease that disables their continuity in the treatment * start another type of treatment * show changes in physical activity and/or eating routine during the research * has severe depression (BDI \> 35).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogic Scale | baseline, one month, two month | This scale will be used to measure the patients' pain intensity. The scale consists of a 100 mm line within the limits of no pain and worst possible pain. The patient is instructed to trace the intensity of his pain within the limits of the line. Changes of 1.1 to 1.2 cm indicate minimal clinical improvement. |
| pressure pain threshold | baseline, one month, two month | We analyzed the following points with the pressure algometer: anterior and posterior fibers of the temporal muscle, frontal region, insertion of the sternocleidomastoid muscle, insertion and middle fibers of the upper trapezius muscle, thenar region of the right upper limb. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-Form Health Survey Questionnaire | baseline, one month, two month | This questionnaire assesses health-related quality of life. This test consists of 36 items. Higher scores indicate greater functionality. |
| Patients' Global Impression of Change Scale | baseline, one month, two month | This scale rates the improvement associated with the intervention on a 7-item scale ranging from 1=no change to 7=much better. |
| Beck Depression Inventory | baseline, one month, two month | This questionnaire assesses the participants' level of depression. Scores between 0-11 mean minimal depression; between 12-19: mild depression; between 20-35: moderate depression and between 36-63: severe depression. |
| Headache Impact Test | baseline, one month, two month | This test assesses the impact of headache on quality of life. A total score less than 50 means no severity; between 50 and 55, some severity; between 56 and 59, substantial severity; greater than 60, severe impact. |
| Perceived Stress Scale | baseline, one month, two month | It is an instrument composed of 14 questions with response options ranging from zero to four (0=never; 1=almost never; 2=sometimes; 3=almost always, and 4=always). Questions with a positive connotation (4, 5, 6, 7, 9, 10, and 13) have their scores inverted: 0=4, 1=3, 2=2, 3=1, and 4=0. The other questions have negative valence and are added directly. The score is the sum of the scores for each question and can range from 0 to 56. |
| Facial Expression Database | baseline, one month, two month | This is an instrument that evaluates the recognition of facial expressions. The bank of faces from Lacop - Facial Expression Database will be used with expressions of joy, fear, anger, sadness, disgust, and surprise from two male and two female models. The manipulation of the intensity of the expressions will be carried out through the Morpheus 4.0 Software to generate faces with different emotional intensities with incremental advances of 25% from the neutral face until reaching 100% of expression intensity. |
| State-Trait Anxiety Inventory | baseline, one month, two month | This instrument assesses the participants' anxiety. It consists of 40 statements that consider trait anxiety and state anxiety. Answers are given on a four-point Likert-type scale (1 - not to 4 - very much), and the score can vary between 20-80. Anxiety level classification can be low (20-33 points), medium (33-49 points), and high (49-80 points). |
| Migraine Disability Assessment | baseline, one month, two month | This questionnaire assesses the inability to perform activities of daily living of people with migraine.The MIDAS score is divided into grades: Grade I - little or no disability (scores 0-5), grade II - mild disability (scores 6-10), grade III - moderate disability (scores 11-20), and grade IV - severe disability (score equal to or greater than 21). |
Countries
Brazil
Outcome results
None listed