Chu Clermont-Ferrand
Clermont-Ferrand, 63003, France
NCT Number: NCT03887000
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Clermont-Ferrand, 63003, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
Time frame: at day 0
Measure of stress with stress subscale in magnesium and placebo group. This subscale consists of 14 questions of self-evaluation
Time frame: Day0; Day0+28; Day0+84
The revised FIQ questionnaire is a 10-item self-questionnaire that assesses the impact of fibromyalgia
Time frame: Day0; Day0+28; Day0+84
The FIRST questionnaire is a 6-item self-questionnaire that detects fibromyalgia.
Time frame: Day0-7; Day0; Day0+28; Day0+84
Heart rate variability (HRV / HRV) is a measure of changes in heart rate that will provide an estimate of stress. It is usually calculated by analyzing time series of beat-by-beat intervals of the ECG or blood pressure plots.
Time frame: Day0; Day0+28; Day0+84
This scale allows the patient to note the pain on a graduation whose minimum score is 0 and the maximum score is 10.
Time frame: Day0; Day0+28; Day0+84
This self-assessment scale allows the patient to characterize the pain in relation to its psychosocial intensity and impact. The patient is asked to answer 9 graduated questions by circling a number from 0 (no pain) to 10 (the most horrible pain you can imagine).
Time frame: Day0; Day0+28; Day0+84
The Trail Making Test (TMT) is recognized as one of the most frequently used neuropsychological tests in clinical practice alternating numbers and letters (1-A-2-B-3- C, etc.).
The Cantab® is a comprehension test, executive functions, memory, attention and decision-making.
Time frame: Day0; Day0+28; Day0+84
The Trail Making Test (TMT) is recognized as one of the most frequently used neuropsychological tests in clinical practice alternating numbers and letters (1-A-2-B-3- C, etc.).
Time frame: Day0; Day0+28; Day0+84
The Cantab® is a comprehension test, executive functions, memory, attention and decision-making.
Time frame: Day0; Day0+28; Day0+84
The International Affective Picture System (IAPS) is a library of 1200 standardized images that can induce an emotional reaction, constituting as many emotional stimuli (positive or negative) or not (neutral).
Time frame: Day0; Day0+28; Day0+84
The Global Impression of Change Patient is a scale of global perception of change ("deterioration" or "improvement") completed by the patient. This scale is graduated from 1 = much better to 7 = significantly worse
Time frame: Day0; Day0+28; Day0+84
The Pittsburg Sleep Quality Index is a self-administered questionnaire with 19 items. It has been developed to measure the quality of sleep in the month preceding the interview with the patient. This questionnaire has 7 components: subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of a sleep medication, and poor daytime fitness
Time frame: Day0; Day0+28; Day0+84
The fatigue severity scale is a 9-item self-questionnaire to assess the patient's fatigue intensity. The patient is asked to circle a number from 1 to 7 for each question, a low value representing a low intensity
Time frame: Day0; Day0+28; Day0+84
The EPICES questionnaire is composed of 11 binary questions (yes / no) allowing to calculate an individual score indicating the precariousness and inequalities of health ranging from 0 to 100.
Time frame: Day0; Day0+28; Day0+84
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Time frame: Day0; Day0+28; Day0+84
assessed by a quality of life questionnaire (Short Form 12 items Short Form survey (SF12)
Time frame: AT Day0; Day0+28
Sudoscan® (Impeto Medical, Paris, France) is a new device that provides a rapid, non-invasive and reproducible quantitative assessment of sweat function.
Time frame: at Day0
A skin biopsy will be realized for histological analysis to determine the presence of small fiber neuropathy.
Time frame: D0; D0+28; D0+84
The intracellular magnesium concentrations will be determined by the blood samples taken at the inclusion visit, at the end of the treatment on visit 3 (D0 + 28) and on visit 4 (D0 + 84).
Time frame: D0; D0+28; D0+84
The erythrocyte magnesium concentrations will be determined by the blood samples taken at the inclusion visit, at the end of the treatment on visit 3 (D0 + 28) and on visit 4 (D0 + 84).
Time frame: D0; D0+28; D0+84
The urinary concentration of magnesium will be determined by the urine collected for 24 hours, the day before visits 3 and 4.
Time frame: D0+28; D0+84
The urinary concentration of magnesium will be determined by the urine collected for 24 hours, the day before visits 3 and 4.
Time frame: D0-7
The creatinine concentrations will be determined by the blood samples taken at the inclusion visit.
Time frame: 24 hours before the visit 2
Analysis of the microbiota: the patient must carry out the collection at her home maximum 24 hours before the visit 2 by following the technical instructions described in the explanatory note that will be provided. She will then ensure that the stool preservation and transport procedure described in this document is followed.
Time frame: Day0-7
Identification of genes involved
Time frame: Day0; Day0+28
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" following different visual stimulation induced by different colors during the anticipatory phase of pain.
Time frame: Day0; Day0+28
Pain intensity will be assessed by the numerical pain rating scale (NPRS): the scale ranges from 0 "no pain" to 10 "maximal tolerable pain" following different thermal stimulations (using Pathway Medoc®).
Time frame: day 0
EMG motor and sensitive of the median nerve on both arm to control the speed of electrical conduction. For this purpose, we will measure the amplitude, latency and speed for the motor test, and the amplitude and speed for the sensitivity test.
University Hospital, Clermont-Ferrand
Other
Effect of Magnesium on Stress in Fibromyalgia: Randomized Double-blind Placebo Controlled Trial
Acronym: SeMAFor
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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