Impact of the Placebo Effect on the Effects of Trancranial Direct Current Stimulation in Fibromyalgia

NCT05903079 | Completed

• 1 other identifier: 20220596
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-restorative sleep, cognitive alterations, depressive and neurovegetative symptoms. Conventional pharmacological therapies are known to produce responses with little clinical impact in more than 50% of patients. Functional alterations of the motor cortex and its connections with subcortical structures have also been demonstrated in FM. Based on the above, the objective of this research is to identify subgroups of patients with greater potential for response to treatment with a view to advancing diagnosis and treatment. In this study, the therapeutic target will be transcranial direct current stimulation (tDCS) according to the potential of responsiveness to the placebo effect, with the precise location of the stimulation area by a neuronavigation system, with the objective of counter-regulating the processes dysfunctional factors responsible for triggering and maintaining FM symptoms. Therefore, this clinical trial aims to compare the effectiveness of anodal tDCS applied to the primary motor cortex (M1) compared to sham tDCS in FM, according to susceptibility to the placebo effect and serum endorphin levels.

Conditions

Fibromyalgia

Keywords

Fibromyalgia, tDCS, Placebo effect

Outcome Measures

Primary Outcomes (1)

• Change in pain level - first phase

  Change from before and after the First phase of treatment on Pain scores assessed by a Numerical Pain Scale (NPS 0 to 10) (0 means no pain - 10 means the worst pain imaginable)

  Time Frame: 1 month

Study Arms (2)

Respondres placebo effect

PLACEBO COMPARATOR

Braço: Comparador de placebo: responde ao efeito placebo Intervenção: 'Estimulação Transcraniana por Corrente Contínua - tDCS Os pacientes receberão tratamento de estimulação tDCS córtex motor primário (M1). De acordo com o sistema 10-20 EEG, o ânodo será colocado no F3 esquerdo e o cátodo no FP2 direito. A estimulação placebo utiliza uma corrente de 2 miliamperes durante os primeiros minutos, nos 10 min e nos 19 minutos.

Device: s-Tdcs

No Respondres placebo effect

ACTIVE COMPARATOR

Braço: Comparador de placebo: responde ao efeito placebo Intervenção: 'Estimulação Transcraniana por Corrente Contínua - tDCS Os pacientes receberão tratamento de estimulação tDCS córtex motor primário (M1).De acordo com o sistema 10-20 EEG, o ânodo será colocado no F3 esquerdo e o cátodo no FP2 direitol. A estimulação placebo utiliza uma corrente de 2 miliamperes durante os primeiros minutos, nos 10 min e nos 19 minutos

Device: s-Tdcs

Interventions

s-Tdcs DEVICE

In the sham condition, a 2 mA current is applied only during brief ramp-up and ramp-down periods at the beginning of the session and at predefined time points (10 and 19 minutes), without sustained stimulation. In the active condition, a continuous 2 mA current is delivered for 20 minutes.

No Respondres placebo effect; Respondres placebo effect

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 to 65 years; who can read and write, with a confirmed diagnosis of FM according to the American College of Rheumatology criteria (2010-2016). Pain score equal to or greater than six on the Numerical Pain Scale (NPS 0-10) on most days of the last 3 months.

You may not qualify if:

• Residing outside the greater Porto Alegre area and pregnancy. Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemakers; cochlear implant; history of alcohol or drug abuse in the last 6 months; neurological pathologies; hx of head trauma or neurosurgery; decompensated systemic diseases and chronic inflammatory diseases (lupus, rheumatoid arthritis, Reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or undergoing treatment.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.450-120, Brazil

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Wolnei Caumo, PhD

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher will receive equipment already programmed by a research assistant, so the researcher who will deliver the tDCS to perform stimulation will not know the programed stimulation. Patients will be instructed to discuss aspects of treatment with the respective investigator. Two independent evaluators who will not participate in the consultations where guidance on the use of tDCS will be provided will be trained to make outcome assessments in follow-up. Patients will not be aware of the type of intervention received, since the sham condition produces a stimulus, but no expected effects. In order to study the level of the blinding, at each moment of evaluation, the patient will be asked about the type of intervention that he / she believes to have received (active or simulated), and about the degree of safety in the response, using a standardized questionnaire. The blinding will be evaluated at the end of each treatment week by means of a standardized instrument.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, surgery departament

Model Details: Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: March 5, 2024
• Primary Completion: August 21, 2024
• Study Completion: January 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)