Acupuncture or MBSR for Patients With Fatigue and MS (MS-Fatigue)
27. januar 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
104
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Berlin, Tyskland, 10117
- The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: usual care + acupuncture
standardized acupuncture treatment in addition to usual care
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Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
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Eksperimentell: usual care+mbsr
mindfulness based stress reduction in addition to usual care not recruiting anymore
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Patients of this group receive mindfulness based stress reduction in addition to usual care
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Aktiv komparator: usual care
usual care without additional treatment
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Patients in this group will follow the same treatment for fatigue they received at study entry
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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fatigue severity scale
Tidsramme: 12 weeks
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12 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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fatigue severity scale
Tidsramme: 26 weeks
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26 weeks
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modified fatigue impact scale
Tidsramme: baseline, 8 weeks, 26 weeks
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baseline, 8 weeks, 26 weeks
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therapy response rates
Tidsramme: 12 weeks
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12 weeks
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expanded disability status scale
Tidsramme: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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multipe sclerosis functional composite scale
Tidsramme: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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beck depression inventory II
Tidsramme: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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Body efficacy expectation
Tidsramme: baseline, 12 weeks, 26 weeks
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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.
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baseline, 12 weeks, 26 weeks
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SF-12
Tidsramme: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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HAQUAMS
Tidsramme: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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Costs
Tidsramme: baseline, 12 weeks, 26 weeks
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Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
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baseline, 12 weeks, 26 weeks
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overall treatment effect
Tidsramme: 12 weeks, 26 weeks
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12 weeks, 26 weeks
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immune parameters
Tidsramme: baseline, 12 weeks, 26 weeks
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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
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number of serious adverse events
Tidsramme: 12 weeks, 26 weeks
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12 weeks, 26 weeks
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number of suspected adverse reactions
Tidsramme: 12 weeks, 26 weeks
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12 weeks, 26 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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fMRI
Tidsramme: baseline, 12 weeks, 26 weeks
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e.g.
functional connectivity in a subgroup of 20 subjects in each group
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baseline, 12 weeks, 26 weeks
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Dynamics of saccade parameters
Tidsramme: baseline, 12 weeks, 26 weeks, and directly after one acupuncture session
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Eye movement analysis will be performed according established standards (Finke et al, J Neurol 2012)
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baseline, 12 weeks, 26 weeks, and directly after one acupuncture session
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Qualitative interviews regarding therapy
Tidsramme: 26 weeks
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Part of the patients will be interviewed about the therapies.
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26 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Claudia M Witt, MD, Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
- Hovedetterforsker: Friedemann Paul, MD, The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2013
Primær fullføring (Faktiske)
1. juni 2015
Studiet fullført (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først innsendt
2. april 2013
Først innsendt som oppfylte QC-kriteriene
24. mai 2013
Først lagt ut (Anslag)
30. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. januar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. januar 2016
Sist bekreftet
1. januar 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MS-Fatigue-13
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