DRKS00029024已完成2 期
Delving in the behavioural and neural correlates of pain perception using a therapy combining mindfulness meditation and transcranial direct current stimulation for the treatment of fibromyalgia syndrome. - Med_tDCS_Fibro
niversitätsmedizin Göttingen0 个研究点目标入组 44 人开始时间: 2022年5月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 30 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Stable disease for at least 6 months prior to participation
- •2. No new treatment approaches over the preceding 3 months
- •3.Stable allowed fibromyalgia related medications (see below) for = 4 weeks prior to the
- •study. List of allowed medications:
- •-Intake of NSAIDs and coxibs as required (bei Bedarf), but participants must not take it 24
- •hours prior to study visits.
- •- Commonly used antidepressants for FMS will be allowed.
- •-Low dose (<25 mg THC content/day) of medical oromucosal cannabinoid therapy (e.g.
- •dronabinol, nabiximols, extracts). The participant has to refrain from taking it up to 24 hours
- •prior to study visits.
- •-Corticosteroids for comorbid conditions if the dose was constant within the last four
- •weeks before baseline and if the dose will likely remain constant for the duration of this trial.
排除标准
- •1. Treatment with any of the following medications:
- •- Strong opioids, or taking more than three medications for fibromyalgia symptom relief.
- •- Carbamazepine, benzodiazepines, phenytoin, gabapentin, pregabalin; calcium channel
- •antagonists (e.g. flunarizine), NMDA receptor antagonists (e.g. dextromethorphan, memantine),
- •anticholinergics.
- •- Therapeutic local anesthetic infiltration of the spinal column within the last 4 weeks
- •before baseline and/or planned during the trial period.
- •- Topically administered medication with influence on the study target during the study
- •Inhaled or smoked cannabinoids for medical use.
- •2. presence of any major, acute or unstable medical, neurological or psychiatric disorder,
- •diagnosis of severe or uncontrolled comorbid rheumatic disease, non-treated tumors, ongoing
- •chemo- or radiation therapy, clotting disorders or anticoagulant therapy
- •3. Chronic migraine (at least 15 headache days/months, with at least 8 fulfilling criteria for
- •4. Alcohol/drug addiction, abuse of any substance (except nicotine and caffeine) currently
- •and/or within the last 12 months prior to randomization
- •5. Pregnancy or breastfeeding
- •6. History of unexplained or repeated loss of consciousness
- •7. Implanted metallic devices in head, neck or chest
- •8. Participation in another scientific or clinical study within 12 weeks prior to study
- •9. History of major surgery in the last three months
- •10. Planned or ongoing pension proceedings
- •11. Any planned surgery or inpatient treatment which might conflict with or influence the
- •participation or results of the study.
- •12.History or suspicion of unreliability, poor co-operation or non-compliance with medical
- •13. Mental condition, legal incapacity, and/or other circumstances rendering the patient
- •unable to understand the nature, scope and possible consequences of the study
- •14. Acupuncture or chiropractic manipulations within the last 4 weeks before baseline
- •and/or during the trial.
- •15.Formal meditation practice of high intensity
研究者
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