Acupuncture or MBSR for Patients With Fatigue and MS (MS-Fatigue)
27 januari 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
104
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Berlin, Tyskland, 10117
- The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
fatigue severity scale
Tidsram: 12 weeks
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12 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
fatigue severity scale
Tidsram: 26 weeks
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26 weeks
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modified fatigue impact scale
Tidsram: baseline, 8 weeks, 26 weeks
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baseline, 8 weeks, 26 weeks
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therapy response rates
Tidsram: 12 weeks
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12 weeks
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expanded disability status scale
Tidsram: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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multipe sclerosis functional composite scale
Tidsram: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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beck depression inventory II
Tidsram: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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Body efficacy expectation
Tidsram: 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.
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baseline, 12 weeks, 26 weeks
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SF-12
Tidsram: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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HAQUAMS
Tidsram: baseline, 12 weeks, 26 weeks
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baseline, 12 weeks, 26 weeks
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Costs
Tidsram: 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
Tidsram: 12 weeks, 26 weeks
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12 weeks, 26 weeks
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immune parameters
Tidsram: 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
Tidsram: 12 weeks, 26 weeks
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12 weeks, 26 weeks
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number of suspected adverse reactions
Tidsram: 12 weeks, 26 weeks
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12 weeks, 26 weeks
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
fMRI
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Claudia M Witt, MD, Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
- Huvudutredare: Friedemann Paul, MD, The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2013
Primärt slutförande (Faktisk)
1 juni 2015
Avslutad studie (Faktisk)
1 oktober 2015
Studieregistreringsdatum
Först inskickad
2 april 2013
Först inskickad som uppfyllde QC-kriterierna
24 maj 2013
Första postat (Uppskatta)
30 maj 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 januari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 januari 2016
Senast verifierad
1 januari 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MS-Fatigue-13
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