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- Ensaio Clínico NCT07573709
Functional and Affective Effects of a Brief tDCS Intervention in Fibromyalgia and Chronic Fatigue Syndrome (FibFatDCS)
Visão geral do estudo
Status
Descrição detalhada
Abstract Background: Fibromyalgia (FM) and chronic fatigue syndrome (CFS) are characterized by persistent, multidimensional symptoms arising from complex brain-body interactions that impair functioning and quality of life. Noninvasive neuromodulation techniques such as transcranial direct current stimulation (tDCS) have been proposed as adjunctive approaches to support short-term functional changes within distributed neural systems, although evidence remains limited and heterogeneous. Objective: To examine immediate pre-post changes in multidimensional clinical outcomes following a standardized tDCS protocol in patients with FM and CFS, and to explore potential diagnosis-related response patterns. Methods: Fifteen patients (FM: n = 5; CFS: n = 10) received 10 sessions of tDCS (20 minutes per session) administered over two consecutive weeks (five sessions per week). Patient-reported outcomes were assessed at baseline and immediately after treatment completion. Measures included the Short Form-36 Health Survey (SF-36), Fibromyalgia Impact Questionnaire (FIQ), Hospital Anxiety and Depression Scale (HADS), Composite Autonomic Symptom Score (COMPASS), pain thermometer, Epworth Sleepiness Scale, Fatigue Severity Scale (FSS), and Fatigue Assessment Scale (FAS). Pre-post comparisons were conducted at the whole-sample level, followed by exploratory analyses stratified by diagnosis. Results: At baseline, patients with FM showed lower COMPASS, FSS, FAS, and HADS scores, and higher SF-36 scores, compared to patients with CFS, indicating a relatively less severe clinical profile. Across the sample, pre-post comparisons indicated improvements in FIQ and HADS scores. Exploratory group-specific analyses suggested that FM patients exhibited reductions in depressive symptoms, whereas CFS patients showed improvements in quality of life (SF-36) and functional impact (FIQ). No significant changes were observed in subjective pain intensity or fatigue severity (FSS). Conclusions: These findings suggest partially distinct clinical profiles and differential responsiveness to tDCS across FM and CFS, within the context of baseline differences between groups. Improvements appeared domain-specific, with affective symptoms responding in FM and functional outcomes in CFS, while core symptoms such as pain and fatigue remained unchanged over the intervention period. This pattern provides preliminary support for the idea that short-term neuromodulation may preferentially influence higher-order regulatory processes rather than core symptom generators, underscoring the need for tailored, multidimensional treatment approaches. Nevertheless, given the small sample size, absence of a control condition, and exploratory nature of subgroup analyses, these results should be interpreted with caution. Further controlled
studies are needed to clarify the reliability, specificity, and clinical relevance of these effects.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Gipuzkoa
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San Sebastián, Gipuzkoa, Espanha, 20250
- Hospital Universitario de Donostia
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Diagnosis of Fibromyalgia
- Diagnosis of chronic fatigue syndrome
Exclusion Criteria:
- Having both conditions at the same time
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: The patients with Fibromyalgia
The same treatment is applied (tDCS)
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It is an neuromodulation technic
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Comparador Ativo: The patients with chronic fatigue syndrome
The same treatment is applied ( tDCS)
|
It is a neuromodulation technic
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Visual Pain Scores (VAS)
Prazo: From enrollment to the end of treatment at 2 weeks
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It is measured before and inmediately after the treatment ( tDCS) is applied.
(0-10) Higher scores mean more pain.
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From enrollment to the end of treatment at 2 weeks
|
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Fibromyalgia Impact Questionnaire (FIQ)
Prazo: From enrollment to the end of treatment at 2 weeks
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It measures the impact of fibromyalgia (Scores: 0-100) The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person.
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From enrollment to the end of treatment at 2 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Adolfo Lopez de Munain, Doctor, University Hospital of Donostia
- Diretor de estudo: PEDRO MONTOYA, UNIVERSITY OF BALEARIC ISLANDS, MALLORCA
Publicações e links úteis
Publicações Gerais
- Moldofsky H. Fibromyalgia, sleep disorder and chronic fatigue syndrome. Ciba Found Symp. 1993;173:262-71; discussion 272-9. doi: 10.1002/9780470514382.ch15. PMID: 8491102.
- McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004. PMID: 8277801.
- Lloyd, D. M., Wittkopf, P. G., Arendsen, L. J., & Jones, A. K. P. (2020). Is transcranial direct current stimulation (tDCS) effective for the treatment of pain in fibromyalgia? A systematic review and meta-analysis. The Journal of Pain, 21(11-12), 1085-1100. https://doi.org/10.1016/j.jpain.2020.01.003
- Lerdal A, Kottorp A. Psychometric properties of the Fatigue Severity Scale-Rasch analyses of individual responses in a Norwegian stroke cohort. Int J Nurs Stud. 2011 Oct;48(10):1258-65. doi: 10.1016/j.ijnurstu.2011.02.019. Epub 2011 Mar 16. PMID: 21414620.
- Hendriks C, Drent M, Elfferich M, De Vries J. The Fatigue Assessment Scale: quality and availability in sarcoidosis and other diseases. Curr Opin Pulm Med. 2018 Sep;24(5):495-503. doi: 10.1097/MCP.0000000000000496. PMID: 29889115
- Hawker, G. A., et al. (2011).Measures of adult pain: Visual Analog Scale for Pain (VAS Pain). Arthritis Care & Research, 63(S11), S240-S252. https://doi.org/10.1002/acr.20543
- Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Board on the Health of Select Populations; Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington (DC): National Academies Press (US); 2015 Feb 10. 7, Recommendations. Available from: https://www.ncbi.nlm.nih.gov/books/NBK284910/
- Burckhardt CS1, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation.J Rheumatol. 1991 May;18(5):728-33.
- Bartholomew EJ, Medvedev ON, Petrie KJ, Chalder T. Rasch analysis of the hospital anxiety and depression scale in patients with chronic fatigue syndrome. J Psychosom Res. 2025 Oct;197:112370. doi: 10.1016/j.jpsychores.2025.112370. Epub 2025 Sep 3. PMID: 40939313.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Neuroinflamatórias
- Manifestações Neurológicas
- Doenças musculoesqueléticas
- Doenças do Sistema Nervoso
- Doenças Musculares
- Processos Patológicos
- Encefalomielite
- Doenças Neuromusculares
- Doença crônica
- Atributos da doença
- Doenças Reumáticas
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor
- Síndrome de Fadiga, Crônica
- Fibromialgia
- Fadiga
Outros números de identificação do estudo
- #061CER24
- European Regional Development (Outro identificador: grant #PID2022-140561NB-I00.)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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