FatigueMS-FatigueNCT01864707
Acupuncture or MBSR for Patients With Fatigue and MS
A study of Fatigue and Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatigue, Multiple Sclerosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatigue, Multiple Sclerosis
- Being tested
- Usual care + acupuncture, usual care+mbsr, usual care
- Keywords
- multiple sclerosis, fatigue
- Medical subject headings
- Fatigue, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care + acupunctureOther
Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
usual care+mbsrOther
Patients of this group receive mindfulness based stress reduction in addition to usual care
usual careOther
Patients in this group will follow the same treatment for fatigue they received at study entry
| Study group | Role | What they receive |
|---|---|---|
| usual care + acupuncture | Experimental | standardized acupuncture treatment in addition to usual care Receives: Other: Usual care + acupuncture |
| usual care+mbsr | Experimental | mindfulness based stress reduction in addition to usual care not recruiting anymore Receives: Other: usual care+mbsr |
| usual care | Active comparator | usual care without additional treatment Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue severity scale
Measured: 12 weeks
Secondary outcomes (14)
fatigue severity scale
Measured: 26 weeks
modified fatigue impact scale
Measured: baseline, 8 weeks, 26 weeks
therapy response rates
Measured: 12 weeks
expanded disability status scale
Measured: baseline, 12 weeks, 26 weeks
multipe sclerosis functional composite scale
Measured: baseline, 12 weeks, 26 weeks
beck depression inventory II
Measured: 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.
Measured: baseline, 12 weeks, 26 weeks
SF-12
Measured: baseline, 12 weeks, 26 weeks
HAQUAMS
Measured: 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.
Measured: baseline, 12 weeks, 26 weeks
overall treatment effect
Measured: 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.
Measured: baseline, 12 weeks, 26 weeks
number of serious adverse events
Measured: 12 weeks, 26 weeks
number of suspected adverse reactions
Measured: 12 weeks, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M Witt, MD, Principal investigator, Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin BerlinFriedemann Paul, MD, Principal investigator, The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864707
- Sponsor's protocol ID
- MS-Fatigue-13
- Acronym
- MS-Fatigue
- Status last verified
- Jan 2016
- First submitted
- 2 Apr 2013
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01864707
- Acronym / sponsor ID
- MS-Fatigue / MS-Fatigue-13
- Conditions
- Fatigue, Multiple Sclerosis
- Keywords
- multiple sclerosis, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| usual care + acupuncture | Experimental | Other: Usual care + acupuncturestandardized acupuncture treatment in addition to usual care |
| usual care+mbsr | Experimental | Other: usual care+mbsrmindfulness based stress reduction in addition to usual care not recruiting anymore |
| usual care | Active comparator | Other: usual careusual care without additional treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care + acupuncturePatients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care | Other | usual care + acupuncture |
| usual care+mbsrPatients of this group receive mindfulness based stress reduction in addition to usual care | Other | usual care+mbsr |
| usual carePatients in this group will follow the same treatment for fatigue they received at study entry | Other | usual care |
Primary outcome
fatigue severity scale
Time frame: 12 weeks
14 secondary outcomes
fatigue severity scale
Time frame: 26 weeks
modified fatigue impact scale
Time frame: baseline, 8 weeks, 26 weeks
therapy response rates
Time frame: 12 weeks
expanded disability status scale
Time frame: baseline, 12 weeks, 26 weeks
multipe sclerosis functional composite scale
Time frame: baseline, 12 weeks, 26 weeks
beck depression inventory II
Time frame: baseline, 12 weeks, 26 weeks
Body efficacy expectation
Time frame: baseline, 12 weeks, 26 weeks
SF-12
Time frame: baseline, 12 weeks, 26 weeks
HAQUAMS
Time frame: baseline, 12 weeks, 26 weeks
Costs
Time frame: baseline, 12 weeks, 26 weeks
overall treatment effect
Time frame: 12 weeks, 26 weeks
immune parameters
Time frame: baseline, 12 weeks, 26 weeks
number of serious adverse events
Time frame: 12 weeks, 26 weeks
number of suspected adverse reactions
Time frame: 12 weeks, 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia M Witt, MD principal investigator
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
Friedemann Paul, MD principal investigator
The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fatigue and Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue severity scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.