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Effect of home Eletric Stimulation on pain in Rheumatoid Arthritis patients with low inflammation

Effect of home Direct Current Transcranial Stimulation on pain in Rheumatoid Arthritis patients with low inflammatory activity: a randomized, controlled, double-blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9tnwp85
Enrollment
Unknown
Registered
2023-06-20
Start date
2022-04-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sero-positive rheumatoid arthritis

Interventions

This is a randomized, controlled, double-blind clinical trial. The transcranial direct current stimulation device performed at home (ETCC-D) will be used. The device used will be previously programmed
E02.331.750

Sponsors

Hospital de Clinicas de Porto Alegre
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Participants aged 18-70 years from the arthritis clinic will be included rheumatoid disease at the Hospital de Clínica de Porto Alegre (HCPA) who fulfill the following criteria:Participants diagnosed with RA according to the 2010 American criteria College of Rheumatology and the European League Against Rheumatism and determined by the clinical evaluation of a certified rheumatologist; Participants with RA and generalized pain for more than 3 months that is not of character mechanical or inflammatory, evaluated by a certified rheumatologist;Participants with pain assessed by the EVA-D visual analogue scale with a higher value than 40mm (moderate to severe pain) reported by the participant and/or recorded in the last consultations within the 3-month period prior to inclusion; Inflammatory Tests CRP less than 0.5 mg/dl and ESR less than 15 mm/h in the last exams performed in the 3-month period prior to inclusion; Treatment for stable RA, defined as unchanged doses of NSAIDs and/or opioids and/or DMARD in the 6 months prior to the start of the study protocol and doses of prednisone less than or equal to 5mg per day in the 6 months preceding the study; Stable treatment of antidepressants or anticonvulsants if using them for the treatment of pain, defined as no dose changes in the 6 months that precede the study; Possibility of maintaining doses of NSAIDs, DMARDs, corticosteroids, antidepressants and anticonvulsants without changes during the study; Being right-handed; Ability to give informed consent

Exclusion criteria

Exclusion criteria: Having contraindications for the use of Transcranial Direct Current Stimulation (tDCS): history of brain surgery, history of traumatic brain injury, history of stroke, previous implantation intracranial of any type of metal, pregnant or breastfeeding; Have a previous history of an autoimmune disease other than rheumatoid arthritis, fibromyalgia and osteoarthritis; Have a previous history of neurological disease; Have a previous history of neoplasia; Have a previous history of any other uncompensated medical illness (heart disease,kidney disease, liver disease, etc.); Use of illicit drugs in the last 6 months

Design outcomes

Primary

MeasureTime frame
It is expected to find a statistically significant (p > 0,05) decrease in the patients' painful symptoms.

Secondary

MeasureTime frame
It is expected to observe statistically significant (p > 0,05) improvement in the parameters of central sensitization, sleep quality, fatigue score, quality score in daily activities, pain catastrophizing score and depression score.

Countries

Brazil

Contacts

Public ContactRicardo Xavier

Hospital de Clinicas de Porto Alegre

rvaxier10@gmail.com+55 (51) 33596246

Outcome results

None listed

Source: REBEC (via WHO ICTRP)