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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- fatigue severity scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
fatigue severity scale
时间窗: 12 weeks
次要结局
- therapy response rates(12 weeks)
- multipe sclerosis functional composite scale(baseline, 12 weeks, 26 weeks)
- beck depression inventory II(baseline, 12 weeks, 26 weeks)
- immune parameters(baseline, 12 weeks, 26 weeks)
- number of suspected adverse reactions(12 weeks, 26 weeks)
- fatigue severity scale(26 weeks)
- modified fatigue impact scale(baseline, 8 weeks, 26 weeks)
- Body efficacy expectation(baseline, 12 weeks, 26 weeks)
- expanded disability status scale(baseline, 12 weeks, 26 weeks)
- overall treatment effect(12 weeks, 26 weeks)
- number of serious adverse events(12 weeks, 26 weeks)
- SF-12(baseline, 12 weeks, 26 weeks)
- HAQUAMS(baseline, 12 weeks, 26 weeks)
- Costs(baseline, 12 weeks, 26 weeks)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany