Effect of Home-Based Transcranial Direct Current Stimulation on Pain in Patients With Rheumatoid Arthritis With Low Inflammatory Activity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tDCS.
- Who it may be relevant to
- Registry conditions: Rheumatic Arthritis, Chronic Pain. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Home-Based Transcranial Direct Current Stimulation on Pain in Patients With Rheumatoid Arthritis With Low Inflammatory Activity: A Randomized, Double-Blind, Sham-Controlled Clinical Trial
Overview
Rheumatoid arthritis (RA) is a highly complex inflammatory autoimmune disease. Several drugs have been developed in recent decades to target the immune components of inflammation. However, even with effective anti-inflammatory and immunosuppressive therapies for controlling RA, many patients still report significant levels of chronic pain due to CNS neuroplasticity, perpetuating physical disability, psychosocial problems, decreased work activity, and poor quality of life. In addition, chronic pain can lead to increased public spending due to the need for more medical visits, ineffective drug treatments, and financial disability benefits. Transcranial stimulation (a noninvasive neural stimulation technique with minimal adverse effects and easy home use) has been a promising adjunct tool in the treatment of chronic pain and psychological disorders in diseases that affect the central nervous system in the long term. Thus, exploring transcranial direct current stimulation in RA patients with low levels of inflammation could impact on improving pain, functionality, psychological aspects and overall quality of life, as well as reducing healthcare costs for society.
Detailed description
Rheumatoid arthritis (RA) is a highly complex inflammatory autoimmune disease. Several drugs have been developed in recent decades to target the immune components of inflammation. However, even with effective anti-inflammatory and immunosuppressive therapies for controlling RA, many patients still report significant levels of chronic pain due to CNS neuroplasticity, perpetuating physical disability, psychosocial problems, decreased work activity, and poor quality of life. In addition, chronic pain can lead to increased public spending due to the need for more medical visits, ineffective drug treatments, and financial disability benefits. Transcranial stimulation (a noninvasive neural stimulation technique with minimal adverse effects and easy home use) has been a promising adjunct tool in the treatment of chronic pain and psychological disorders in diseases that affect the central nervous system in the long term. Thus, exploring transcranial direct current stimulation in RA patients with low levels of inflammation could impact on improving pain, functionality, psychological aspects and overall quality of life, as well as reducing healthcare costs for society.
Interventions
- Device tDCS
Home-Based Transcranial Direct Current Stimulation
Primary outcome measures
- VAS pain [Time frame: Visual Analog Scale (VAS, 0-100 mm; higher scores indicate worse pain) assessed at baseline (Day 1), after 10 days of tDCS treatment, at Week 4 of tDCS treatment (end of treatment), and at 3, 6, 9, and 12 months post-treatment.]
Eligibility criteria
Inclusion criteria
- Participants aged 18-70 with RA.
- Participants with generalized pain ≥ 40 mm on the VAS-Pain scale, lasting over 3 months, and not of mechanical or inflammatory origin, as assessed by a certified rheumatologist.
- Evidence of low inflammatory markers, including with C-reactive protein (CRP) <10 mg/dL and sedimentation rate (ESR) <20 mm/h, and stable treatment for PsA for at least 6 months prior to study enrollment.
Exclusion criteria
- History of brain surgery, traumatic brain injury, stroke, previous intracranial metal implantation, pregnancy, or breastfeeding.
- Previous history of autoimmune diseases other than RA.
- History of neurological diseases.
- Previous history of neoplasia.
- History of any other uncompensated clinical disease.
- Use of illicit drugs within the past 6 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital de Clínicas de Porto Alegre — Porto Alegre
Publications
- Caumo W, Lopes Ramos R, Vicuna Serrano P, da Silveira Alves CF, Medeiros L, Ramalho L, Tomeddi R, Bruck S, Boher L, Sanches PRS, Silva DP Jr, Ls Torres I, Fregni F. Efficacy of Home-Based Transcranial Direct Current Stimulation Over the Primary Motor Cortex and Dorsolateral Prefrontal Cortex in the Disability Due to Pain in Fibromyalgia: A Factorial Sham-Randomized Clinical Study. J Pain. 2024 Feb PMID 37689323
Identifiers
NCT: NCT07162311 · 2024-0014