Chronic Pain, Rheumatic Arthritis
Conditions
Keywords
Rheumatoid arthrtis, chronic pain, tDCS
Brief summary
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
DEVICEtDCS
Home-Based Transcranial Direct Current Stimulation
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS pain | 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. | Visual Analogue Scale for pain |
Countries
Brazil
Outcome results
None listed