Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.

ConditionsCOVID-19 Long COVID Long Covid19 SARS CoV 2 Infection Persistent COVID-19 Migraine Disorders Headaches Chronic Cluster Headache Arthralgia Myalgia Chronic Pain Post-COVID-19 Syndrome Post COVID-19 Condition Sleep Quality Insomnia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age16+

SponsorFundación Universidad Católica de Valencia San Vicente Mártir

About this trial

This study aims to verify the efficacy/effectiveness of treatment with transcranial direct current stimulation (TDCS) in patients with Long Covid who experience headaches, migraines, and chronic pain, such as arthralgia and myalgia, as well as sleep problems. Transcranial direct current stimulation is used in the field of Physiotherapy and Rehabilitation, with results that have proven to be effective for treating patients suffering from symptoms like migraines, headaches, chronic pain, fibromyalgia, or chronic neuropathic pain and insomnia. As you can see, in the case of patients with Long Covid, we find several of these symptoms, so it is suggested that if transcranial direct current therapy (TDCS) gives such good results in relieving these symptoms, why couldn't it give such good results and help just as much in patients with Long Covid, since many of the symptoms are the same, even if the origin or cause is different.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with Persistent Covid

Men and women

All ages from 16 years old

Patients who passed the Covid in its acute phase in an asymptomatic, mild and severe way.

Disqualifiers

Patients without confirmation with positive PCR in the acute phase of Covid-19

Patients with Persistent Covid who do not have at least one of these symptoms: migraines, headaches, chronic pain, neuropathic pain, arthralgia, myalgias

Patients with pacemaker / defibrillator

Patients with brain implants

Trial design

Design model

Parallel

Treatments tested in this trial

Transcranial Direct Current Therapy (tDCS)
Device
Transcranial direct therapy (tDCS) is a non-invasive neuromodulation therapy of the cerebral cortex, which consists of the application of electrical microcurrents, of approximately 2mA, through surface electrodes placed on the scalp. Transcranial therapy (tDCS) produces immediate effects on the ability of neurons to change their electrical potential. Each session lasts between 20 and 30 minutes, and approximately 20 consecutive sessions should be performed. It will be applied through two surface electrodes of 25 to 35 cm2 at 2 mA. The equipment has a European health certificate (CE), so it is an approved equipment that complies with all the safety measures for the application of the treatment.
Sham (No Treatment)
Device
Same electrode montage as other arm; current ramped up and then down, then switched off, to mimic the sensations of active stimulation. Same session schedule as active arms.

Treatment groups

87 Participants

are divided into 4 treatment groups

Group A: ShamPlacebo comparator 1 intervention

Group B: Anodal tDCSExperimental treatment 1 intervention

Group C: Cathodal tDCSExperimental treatment 1 intervention

Group D: Bifrontal tDCSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

CHANGE FROM PRE-TREATMENT DEGREE CHRONIC BODY PAIN AT INMEDIATE POST-TREATMENT, 1 MONTH, 3 MONTHS AND 6 MONTHS

MEASURED WITH 2 SPECIFIC PAIN SCALES (EVA-Visual Analog SCALE AND MCGILL PAIN QUESTIONNAIRE). EVA SCALE (0 no pain-10 maximun pain). MCGILL QUESTIONNAIRE (0 no pain-66 maximun pain)

Time frame