Effect of Magnesium on Stress in Fibromyalgia: Randomized Double-blind Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Measure of stress with DASS-42
研究概览
简要总结
Fibromyalgia affects an average of 2% of the French population. Data from the literature report that low levels of magnesium could be associated with fibromyalgia. However, no study to date has investigated the effect of oral magnesium administration on stress in fibromyalgia.
This trial therefore aims to evaluate whether magnesium could improve stress and the various disorders that contribute to the complexity of fibromyalgia, including pain, cognition, sleep disorders and quality of life.
详细描述
This is an interventional, randomized, placebo-controlled, double blind study of the use of magnesium in fibromyalgia. The effect of magnesium on stress measured by DASS-42 over 28 days after taking magnesium / placebo will be studied.
The secondary objectives will evaluate the evolution of the scores of all the tests and questionnaires carried out before taking magnesium or placebo (D0: Visit 2), then at D0 + 28 (visit 3) and D0 + 84 days (visit 4 corresponding to the end-of-study visit).
Secondary parameters are the following :
Impact of fibromyalgia, heart rate variability, pain intensity, cognition, feelings of patients, impression of change, sleep quality, fatigue intensity, social vulnerability, catastrophism, presence of small fiber neuropathy, stress induced by colors, pain induced by thermal stimulation, concentration of magnesium, analysis of microbiota and evaluation of genetic factor.
Blood magnesium and magnesuria will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient over the age of 18,
- •Patient with fibromyalgia according to the criteria of the 2016 ACR,
- •Patient presenting a score on the DASS-42 > 18 scale,
- •Patient free from any initiation of new treatment or diet at the time of inclusion,
- •Cooperation and understanding sufficient to comply with the requirements of the study,
- •Acceptance to give written consent,
- •Affiliation to the French Social Security system,
- •Registration or acceptance of registration in the National Register of Volunteers participating in research.
排除标准
- •having a contraindication to the administration of magnesium: hypersensitivity to magnesium chloride, or to any of the excipients,
- •with a magnesium concentration of > 1.05 mmol / l,- with severe renal impairment with a creatinine clearance < 30 ml / min,
- •receiving a treatment or dietary supplement containing magnesium at the time of inclusion,
- •treated with antibiotics in the three months prior to inclusion,- who has reported gastroenteritis in the two months prior to inclusion,
- •physically unfit to place the palms or soles of the feet on the Sudoscan® electrodes,
- •having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test (in particular a disease known to cause small fiber neuropathies: diabetes, Sjögren's disease, vasculitis, sarcoidosis, chronic ethylism ....),
- •using anticoagulant therapy or allergy to local anesthetics,- of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman.
- •participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 4500 over the 12 months preceding the start of the trial,
- •having cooperation and understanding that does not allow strict compliance with the conditions laid down in the Protocol,
- •benefiting from a measure of legal protection (guardianship, guardianship, deprivation of liberty, safeguard of justice),
- •not affiliated to the French Social Security system.
研究组 & 干预措施
MAGNESIUM
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
干预措施: placebo (Other)
PLACEBO
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
干预措施: placebo (Other)
MAGNESIUM
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
干预措施: magnesium (Other)
PLACEBO
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
干预措施: magnesium (Other)
结局指标
主要结局
Measure of stress with DASS-42
时间窗: at day 0
Measure of stress with stress subscale in magnesium and placebo group. This subscale consists of 14 questions of self-evaluation
次要结局
- Detection of fibromyalgia using the FIRST questionnaire(Day0; Day0+28; Day0+84)
- Evaluation of the impact of fibromyalgia using the FIQ questionnaire(Day0; Day0+28; Day0+84)
- Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B)(Day0; Day0+28; Day0+84)
- Evaluation of stress by the heart rate variability(Day0-7; Day0; Day0+28; Day0+84)
- Assessment Using Numerical Scale (EN)(Day0; Day0+28; Day0+84)
- Concise Pain Questionnaire (QCD)(Day0; Day0+28; Day0+84)
- Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B) and the Cantab® test(Day0; Day0+28; Day0+84)
- Cantab® test(Day0; Day0+28; Day0+84)
- Social Vulnerability Assessment (EPICES)(Day0; Day0+28; Day0+84)
- Evaluation of the emotions by visualization of images and scale evaluating the feelings of the patients(Day0; Day0+28; Day0+84)
- Evaluation of the overall impression of change by the Patient Global Impression of Change Questionnaire (PGIC)(Day0; Day0+28; Day0+84)
- Evaluation of the impact on the Pittsburg Sleep Quality Index (PSQI)(Day0; Day0+28; Day0+84)
- Evaluation of the intensity of fatigue by the Fatigue Severity Scale (FSS)(Day0; Day0+28; Day0+84)
- Evaluation of catastrophism by the PCS (Pain Catastrophizing Scale) scale(Day0; Day0+28; Day0+84)
- Quality of life (Short Form 12 items Short Form survey)(Day0; Day0+28; Day0+84)
- Evaluation of the presence of small fiber neuropathy (Sudoscan® )(AT Day0; Day0+28)
- Evaluation of the presence of small fiber neuropathy (skin biopsy)(at Day0)
- plasma magnesium dosage(D0; D0+28; D0+84)
- erythrocyte magnesium dosage(D0; D0+28; D0+84)
- urinary magnesium dosage(D0+28; D0+84)
- Analysis of the microbiota (stool samples)(24 hours before the visit 2)
- Evaluation of genetic polymorphism using OpenArray technology(Day0-7)
- creatinine dosage(D0-7)
- Evaluation of stress response during visual stimulation(Day0; Day0+28)
- Evaluation of pain response during thermal stimulation(Day0; Day0+28)
- Evaluation of electromyography (EMG) of median nerve(day 0)
- urinary magnesium dosage(D0; D0+28; D0+84)