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The effect of Transcranial Direct Current Stimulation in pain control in patients with Rheumatoid Arthritis

Transcranial Direct Current Stimulation in pain control in patients with Rheumatoid Arthritis: a randomized, placebo-controlled, double-blind, phase II clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-33t6s52
Enrollment
Unknown
Registered
2022-04-25
Start date
2022-05-01
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

Arthritis, Rheumatoid

Interventions

The Intervention for Interventional Group (27 adults) and Control Group (26 adults) will be administered in patients with unilateral or bilateral pain in which the side with the greatest pain predomin
current amplitude: 2 milliamperes (mA). The electrodes must be 5x7 cm spongy, incorporated with saline instillation and positioned over the M1 region (C3 or C4) and the cathode over the SO area (Fp1 o
E02.331.750

Sponsors

Universidade Federal do Amazonas
Lead Sponsor
Fundação Hospital Adriano Jorge
Collaborator
Hospital Adventista de Manaus
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult volunteers (higher than 18 years) diagnosed with Rheumatoid Arthritis; both genders; with chronic pain longer than 12 weeks or 3 months; with a pain level greater than 7 by the visual analog scale of Pain and who are using synthetic disease-modifying drugs

Exclusion criteria

Exclusion criteria: Volunteers who are using biological disease-modifying drugs; who have neuropsychiatric diseases; who have a history of illicit drug use and abuse; who have neurological, cognitive, or motor deficits; who underwent neurosurgical interventions (craniotomy); who have a clinical diagnosis of severe depression with more than 30 points according to the Beck Depression Inventory tool; who have a history of seizures and/or epilepsy; who are using high doses of opioids (more than 30 mg of Oxycodone, Hydrocodone or 7.5 mg of Hydromorphone or equivalent drug); pregnant women; who have metallic implants in the cranial and/or facial region; who use a pacemaker; with a history of skin diseases; who have other autoimmune diseases not related to Rheumatoid Arthritis; who have cancer diseases; who have disease in the decompensated phase (ischemic heart disease, kidney and/or liver diseases)

Design outcomes

Primary

MeasureTime frame
Reduction in the level of chronic pain, assessed by the Visual Analog Pain Scale (VAS-pain) instrument on a 0-100 scale. Measured one-week pre and post-intervention

Secondary

MeasureTime frame
Reduction in the level of chronic pain, assessed by the instrument Brief Pain Inventory (BPI); Measured one-week pre and post-intervention;Reduction in the level of chronic pain, assessed by 10 consecutive sessions of intervention application. Visual Analog Pain Scale (VAS-pain) instrument on a 0-100 scale; Measured consecutively across 10 sessions;Improvement of the inflammatory activity of the disease, cytokine analysis performed by flow cytometry; Measured one-week pre and post-intervention;Improvement in functional status through the analysis of the Health Assessment Questionnaire (HAQ); Measured one-week pre and post-intervention;Improvement in quality of life through the analysis of the Health Assessment Questionnaire (HAQ); Measured one-week pre and post-intervention;Improvement in the assessment of cardiac autonomic behavior by heart rate variability (HRV) analysis; Measured one-week pre and post-intervention

Countries

Brazil

Contacts

Public ContactPablo Cortez

Universidade Federal do Amazonas

p.c_c@outlook.com+55(92)991090908

Outcome results

None listed

Source: REBEC (via WHO ICTRP)