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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Fatigue
• Intervention / Treatment: Other: Usual care + acupuncture; Other: usual care+mbsr; Other: usual care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: usual care + acupuncture; standardized acupuncture treatment in addition to usual care	Other: Usual care + acupuncture; Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
Experimental: usual care+mbsr; mindfulness based stress reduction in addition to usual care not recruiting anymore	Other: usual care+mbsr; Patients of this group receive mindfulness based stress reduction in addition to usual care
Active Comparator: usual care; usual care without additional treatment	Other: usual care; Patients in this group will follow the same treatment for fatigue they received at study entry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fatigue severity scale	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fatigue severity scale		26 weeks
modified fatigue impact scale		baseline, 8 weeks, 26 weeks
therapy response rates		12 weeks
expanded disability status scale		baseline, 12 weeks, 26 weeks
multipe sclerosis functional composite scale		baseline, 12 weeks, 26 weeks
beck depression inventory II		baseline, 12 weeks, 26 weeks
Body efficacy expectation	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		baseline, 12 weeks, 26 weeks
HAQUAMS		baseline, 12 weeks, 26 weeks
Costs	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		12 weeks, 26 weeks
immune parameters	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		12 weeks, 26 weeks
number of suspected adverse reactions		12 weeks, 26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI	e.g. functional connectivity in a subgroup of 20 subjects in each group	baseline, 12 weeks, 26 weeks
Dynamics of saccade parameters	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	Part of the patients will be interviewed about the therapies.	26 weeks

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Claudia M Witt, MD, Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin; Principal Investigator: Friedemann Paul, MD, The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (Estimate): May 30, 2013

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: multiple sclerosis, fatigue
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue
• Other Study ID Numbers: MS-Fatigue-13