Fatigue | Acupuncture or MBSR for Patients With Fatigue and MS
Fatigue research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Usual care + acupuncturePatients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
Other:usual care+mbsrPatients of this group receive mindfulness based stress reduction in addition to usual care
Other:usual carePatients in this group will follow the same treatment for fatigue they received at study entry
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
usual care + acupuncturestandardized acupuncture treatment in addition to usual care
usual care+mbsrmindfulness based stress reduction in addition to usual care not recruiting anymore
usual careusual care without additional treatment
Start Date: April 2013
Completed Date: October 2015
Primary Outcome: fatigue severity scale
Secondary Outcome: fatigue severity scale
Study sponsors, principal investigator, and references
Principal Investigator: Claudia M Witt, MD
Lead Sponsor: Charite University, Berlin, Germany