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Lo studio clinico NCT03910010 per Fibromialgia è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Brain Imaging Study on Biomarkers for Fibromyalgia 35 Medicina di precisione Basato su biomarcatori Prevenzione

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT03910010 è uno studio interventistico per Fibromialgia, attualmente in arruolamento. Avviato il 1 febbraio 2021, prevede di arruolare 35 partecipanti. Sotto la guida di Nova Scotia Health Authority, dovrebbe concludersi entro il 1 gennaio 2035. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 22 agosto 2024.
Sommario breve
Drugs used for managing Fibromyalgia pain have not proven to be effective and pain continues to cost Canadians $60 billion a year without truly helping those who suffer. The study proposes to investigate the factors related to a person that can enhance or reduce the effectiveness of pain treatments in people suffering with Fibromyalgia pain. Treatment response to painkillers in a person may be related to their brain,...Mostra di più
Titolo ufficiale

Brain Imaging Study on Biomarkers for Fibromyalgia

Patologie
Fibromialgia
Altri ID dello studio
  • 5748
Numero NCT
NCT03910010
Data di inizio (effettiva)
2021-02-01
Ultimo aggiornamento pubblicato
2024-08-22
Data di completamento (stimata)
2035-01
Arruolamento (previsto)
35
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Ricerca sui servizi sanitari
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleExperimental: placebos
Fibromyalgia participants will enter in an optional placebo trial. This phase of the study will test the clinical usefulness of the biomarkers. We will measure how expectation of starting a new treatment reduces 'clinical back pain' in each participant. Positive treatment expectations will be induced by giving them capsules containing inert material and telling them that the capsules contain an effective drug that ha...Mostra di più
Placebo
Positive treatment expectations will be induced by giving participants capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Pain. They will be requested to take two capsules four times a day and report their pain on paper forms organized as a calendar or on REDCap.
Nessun interventoWaitlist
Fibromyalgia participants will not be given any placebo and will be requested to report their pain on paper forms organized as a calendar or on REDCap.
N.D.
Nessun interventoHealthy Controls
Healthy control participants will complete the main part of the study, but will not be asked to take a placebo or be placed on a waitlist.
N.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
pain modulation- using an experimental task that tests a person's ability to form positive expectations.
Brain imaging will be used to assess each participant's capacity to endogenously adjust pain perception with changes in expectations.
3 days after first visit
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì

  • Chronic pain participant inclusion criteria:

    1. 18-75 years of age
    2. Right-handed
    3. Meet the classification criteria of chronic low back pain (having low back pain for more than 6 months).
    4. At least 4/10 clinical pain on the Brief Pain Inventory Scale on average during the two weeks prior to enrollment
    5. Comfortable completing (reading and writing) questionnaires and tasks with English language instructions

Healthy participant inclusion criteria:

  1. 18 - 75 years of age
  2. Right-handed
  3. Comfortable completing (reading and writing) questionnaires and tasks with English language instructions

Chronic pain participant exclusion criteria:

  1. History of cardiac, respiratory, or nervous system disease that may interfere with participation in the study or cause heightened potential for adverse outcome. For example: asthma or claustrophobia
  2. Presence of any contraindications to MRI scanning. For example:

cardiac pacemaker, metal implants, fear of closed spaces, pregnancy

Healthy participant exclusion criteria:

  1. Acute or chronic pain
  2. History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment and by asking the participant about their comfort level and ability, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia
  3. Presence of any contraindications to MRI scanning. For example:

cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Nova Scotia Health Authority logoNova Scotia Health Authority
Contatti principali dello studio
Contatto: Javeria A Hashmi, PhD, 902-473-4603, [email protected]
1 Centri dello studio in 1 paesi

Nova Scotia

Nova Scotia Health Authority, Halifax, Nova Scotia, B3h1V7, Canada
In arruolamento