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Acupuncture or MBSR for Patients With Fatigue and MS (MS-Fatigue)

27. januar 2016 opdateret af: Claudia M. Witt, Charite University, Berlin, Germany

Randomized Controlled Trial on the Efficacy of Acupuncture and the Efficacy of Mindfulness-Based Stress Reduction (MBSR) in Patients With Multiple Sclerosis Suffering From Fatigue

The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In multiple sclerosis, fatigue is the most common clinical symptom, reported by up to 97% of patients. No successful evidence-based therapy exists so far. The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis. We want to include 141 patients with multiple sclerosis and fatigue. Participants will be randomised into three groups to compare 1) usual care, 2) usual care plus standardised acupuncture, and 3) usual care plus mindfulness-based stress reduction. Treatment duration will be 12 weeks. The primary outcome is the Fatigue Severity Scale (FSS) after 12 weeks, follow-up measurement will be performed after 26 weeks. Secondary outcomes include other fatigue specific parameters, other MS specific parameters, cost, and physiological, immunological and functional magnetic resonance imaging parameters.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

104

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Berlin, Tyskland, 10117
        • The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • female or male
  • 18 to 65 years of age
  • able to give oral and signed written informed consent
  • clinical diagnosis of multiple sclerosis
  • fatigue in "multiple sclerosis" for at least 3 months
  • other stable pre-study treatment with respect to target symptom fatigue for at least 3 months before inclusion
  • stable immunomodulatory or immunosuppressive therapy or stable no such a therapy for at least the 3 months before inclusion
  • fatigue score of ≥4 on the Fatigue Severity Scale at inclusion
  • patient's mental and physical ability to participate in the trial
  • willingness to be randomised, to attend visits, to complete questionnaires, and willingness to participate and fMRI measurements

Exclusion Criteria:

  • fatigue because of a malignant disease
  • acute relapse or cortisone therapy therapy in the last 30 days before inclusion
  • EDSS (Extended disability status scale) > 6
  • fatigue specific acupuncture in the last 12 months
  • during the last 12 months performing of MBSR exercises learnt in the past
  • change of immunomodulatory or immunosuppressive therapy during the 3 months before inclusion
  • other new therapies are planned which could have a positive effect on fatigue (e.g. exercise, acupuncture, relaxation therapy)
  • for female patients: pregnancy or anticipated pregnancy during the intervention period
  • severe acute and or chronic disease which does not allow participation in the therapy
  • other limitations which do not allow participation in the therapy
  • alcohol or substance abuse
  • parallel participation in another clinical trial
  • BDI > 29
  • contra indications for fMRI session (e.g. metal clips)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: usual care + acupuncture
standardized acupuncture treatment in addition to usual care
Andet: Usual care + acupuncture
Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
Eksperimentel: usual care+mbsr
mindfulness based stress reduction in addition to usual care not recruiting anymore
Andet: usual care+mbsr
Patients of this group receive mindfulness based stress reduction in addition to usual care
Aktiv komparator: usual care
usual care without additional treatment
Andet: usual care
Patients in this group will follow the same treatment for fatigue they received at study entry

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
fatigue severity scale
Tidsramme: 12 weeks
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
fatigue severity scale
Tidsramme: 26 weeks
26 weeks
modified fatigue impact scale
Tidsramme: baseline, 8 weeks, 26 weeks
baseline, 8 weeks, 26 weeks
therapy response rates
Tidsramme: 12 weeks
12 weeks
expanded disability status scale
Tidsramme: baseline, 12 weeks, 26 weeks
baseline, 12 weeks, 26 weeks
multipe sclerosis functional composite scale
Tidsramme: baseline, 12 weeks, 26 weeks
baseline, 12 weeks, 26 weeks
beck depression inventory II
Tidsramme: baseline, 12 weeks, 26 weeks
baseline, 12 weeks, 26 weeks
Body efficacy expectation
Tidsramme: baseline, 12 weeks, 26 weeks
Body-Efficacy Expectation (BEE) is a scale to measure the conviction that one's body is able to deal with health-threatening factors by itself. It is a six items' scale developed in the Institute of Social Medicine, Epidemiology and Health Economics and not published, yet.
baseline, 12 weeks, 26 weeks
SF-12
Tidsramme: baseline, 12 weeks, 26 weeks
baseline, 12 weeks, 26 weeks
HAQUAMS
Tidsramme: baseline, 12 weeks, 26 weeks
baseline, 12 weeks, 26 weeks
Costs
Tidsramme: baseline, 12 weeks, 26 weeks
Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
baseline, 12 weeks, 26 weeks
overall treatment effect
Tidsramme: 12 weeks, 26 weeks
12 weeks, 26 weeks
immune parameters
Tidsramme: baseline, 12 weeks, 26 weeks

PBMC and proliferationsassays, pro- and antiinflamatory cytokines, axonal damage marker such as neurofilaments and neurotrophic factors like BDNF

possible influences on the immune system will be evaluated in an exploratory way.
baseline, 12 weeks, 26 weeks
number of serious adverse events
Tidsramme: 12 weeks, 26 weeks
12 weeks, 26 weeks
number of suspected adverse reactions
Tidsramme: 12 weeks, 26 weeks
12 weeks, 26 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
fMRI
Tidsramme: baseline, 12 weeks, 26 weeks
e.g. functional connectivity in a subgroup of 20 subjects in each group
baseline, 12 weeks, 26 weeks
Dynamics of saccade parameters
Tidsramme: baseline, 12 weeks, 26 weeks, and directly after one acupuncture session
Eye movement analysis will be performed according established standards (Finke et al, J Neurol 2012)
baseline, 12 weeks, 26 weeks, and directly after one acupuncture session
Qualitative interviews regarding therapy
Tidsramme: 26 weeks
Part of the patients will be interviewed about the therapies.
26 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Charite University, Berlin, Germany

Efterforskere

  • Ledende efterforsker: Claudia M Witt, MD, Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
  • Ledende efterforsker: Friedemann Paul, MD, The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2013

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

2. april 2013

Først indsendt, der opfyldte QC-kriterier

24. maj 2013

Først opslået (Skøn)

30. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MS-Fatigue-13

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Multipel sclerose

Kliniske forsøg med Usual care + acupuncture

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