Effect of Home-Based Transcranial Direct Current Stimulation on Pain in Patients With Rheumatoid Arthritis With Low Inflammatory Activity

NCT ID: NCT07162311

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2028-12-22

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.

Conditions

Rheumatic Arthritis; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acitve tDCS

2 mA, 20 minutes/day, 5 days/week, for 4 weeks, applied at home under remote supervision.

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: DEVICE

Home-Based Transcranial Direct Current Stimulation

Sham tDCS

Same parameters as active tDCS, but current was ramped down after 30 seconds to mimic sensation without delivering stimulation.

Group Type: SHAM_COMPARATOR

tDCS

Intervention Type: DEVICE

Home-Based Transcranial Direct Current Stimulation

Interventions

tDCS

Home-Based Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Pilotti

Principal Investigator; PhD Student in Medical Sciences at the Federal University of Rio Grande do Sul

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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;25(2):376-392. doi: 10.1016/j.jpain.2023.09.001. Epub 2023 Sep 7.

Reference Type: BACKGROUND

PMID: 37689323 (View on PubMed)

Other Identifiers

2024-0014

Identifier Type: -

Identifier Source: org_study_id