Acupuncture or MBSR for Patients With Fatigue and MS
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
What it found
We found no results in the registry or in papers.
This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Usual care + acupuncture
- usual care+mbsr
Compared with
- usual care
What it measured
Main measures
fatigue severity scale
12 weeks
Fatigue
Other measures (14)
fatigue severity scale
26 weeks
Fatiguemodified fatigue impact scale
baseline, 8 weeks, 26 weeks
Fatiguetherapy response rates
12 weeks
expanded disability status scale
baseline, 12 weeks, 26 weeks
Disability progressionmultipe sclerosis functional composite scale
baseline, 12 weeks, 26 weeks
beck depression inventory II
baseline, 12 weeks, 26 weeks
Mood and sleepBody efficacy expectation
baseline, 12 weeks, 26 weeks
SF-12
baseline, 12 weeks, 26 weeks
HAQUAMS
baseline, 12 weeks, 26 weeks
Costs
baseline, 12 weeks, 26 weeks
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Apr 2013
Main results due
Jun 2015
Finished
Oct 2015