Clinical trial NCT05706077: Effects of TDCS and Physical Therapy in Chronic Migraine
Official title: Effects of TDCS and Physical Therapy on Pain in Women with Chronic Migraine: a Factorial Clinical Trial Randomized, Blinded
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine Disorders
Keywords: physical therapy
transcranial direct current stimulation
facial recognition
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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 ).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Visual Analogic Scale
timeFrame: baseline, one month, two month
measure: pressure pain threshold
timeFrame: baseline, one month, two month
Secondary outcomes:
measure: Headache Impact Test
timeFrame: baseline, one month, two month
measure: Migraine Disability Assessment
timeFrame: baseline, one month, two month
measure: Short-Form Health Survey Questionnaire
timeFrame: baseline, one month, two month
measure: Patients' Global Impression of Change Scale
timeFrame: baseline, one month, two month
measure: Beck Depression Inventory
timeFrame: baseline, one month, two month
measure: State-Trait Anxiety Inventory
timeFrame: baseline, one month, two month
measure: Perceived Stress Scale
timeFrame: baseline, one month, two month
measure: Facial Expression Database
timeFrame: baseline, one month, two month
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraiba
state: Paraiba
Study officials:
affiliation: Federal University of Paraiba
name: Renata Aranha
role: PRINCIPAL_INVESTIGATOR
References: