Effects of tDCS and Physical Therapy in Chronic Migraine

Effects of tDCS and Physical Therapy on Pain in Women With Chronic Migraine: A Factorial Clinical Trial Randomized, Blinded

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Device: active tDCS; Other: real Physical Therapy; Other: placebo Physical Therapy; Device: sham tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraíba
    • João Pessoa, Paraíba, Brazil
      • Federal University of Paraíba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active tDCS + real Physical Therapy; Active Transcranial Direct Current Stimulation will be applied associated with real physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. To stimulate the primary motor cortex the active electrode will be positioned on the C3 point and the reference electrode on the contralateral supraorbital region.	Device: active 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.; Other: real Physical Therapy; Manual maneuvers and therapeutic exercises will be performed for 30 minutes, three times a week over four weeks.
Placebo Comparator: active tDCS + placebo Physical Therapy; Active Transcranial Direct Current Stimulation will be applied associated with placebo physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. To stimulate the primary motor cortex the active electrode will be positioned on the C3 point and the reference electrode on the contralateral supraorbital region.	Device: active 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.; Other: placebo 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.
Sham Comparator: sham tDCS + real Physical Therapy; Sham Transcranial Direct Current Stimulation will be applied associated with real physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. The anode electrode will be positioned on the C3 point (primary motor cortex) and the reference electrode on the contralateral supraorbital region.	Other: real Physical Therapy; Manual maneuvers and therapeutic exercises will be performed for 30 minutes, three times a week over four weeks.; Device: sham 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.
Other: sham tDCS + placebo Physical Therapy; Sham Transcranial Direct Current Stimulation will be applied associated with placebo physiotherapy. The electrode position will be performed according to the 10-20 international system of marking and the different montages will be realized by distinct application sites. The anode electrode will be positioned on the C3 point (primary motor cortex) and the reference electrode on the contralateral supraorbital region.	Other: placebo 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.; Device: sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogic Scale	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.	baseline, one month, two month
pressure pain threshold	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.	baseline, one month, two month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Impact Test	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.	baseline, one month, two month
Migraine Disability Assessment	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).	baseline, one month, two month
Short-Form Health Survey Questionnaire	This questionnaire assesses health-related quality of life. This test consists of 36 items. Higher scores indicate greater functionality.	baseline, one month, two month
Patients' Global Impression of Change Scale	This scale rates the improvement associated with the intervention on a 7-item scale ranging from "1=no change" to "7=much better".	baseline, one month, two month
Beck Depression Inventory	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.	baseline, one month, two month
State-Trait Anxiety Inventory	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).	baseline, one month, two month
Perceived Stress Scale	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.	baseline, one month, two month
Facial Expression Database	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.	baseline, one month, two month

Collaborators and Investigators

• Sponsor: Federal University of Paraíba
• Investigators: Principal Investigator: Renata Aranha, Federal University of Paraíba

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; physical therapy; facial recognition
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 65756722.6.0000.5188

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No