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Completed

NCT Number: NCT03887000

Magnesium, Stress and Fibromyalgia

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Magnesium

Other

Fibromyalgia patients taking either magnesium or placebo according to the randomized plan

Placebo

Other

Fibromyalgia patients taking either magnesium or placebo according to the randomized plan

Primary outcomes

  1. Measure of stress with DASS-42

    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

Secondary outcomes

  1. Evaluation of the impact of fibromyalgia using the FIQ questionnaire

    Time frame: Day0; Day0+28; Day0+84

    The revised FIQ questionnaire is a 10-item self-questionnaire that assesses the impact of fibromyalgia

  2. Detection of fibromyalgia using the FIRST questionnaire

    Time frame: Day0; Day0+28; Day0+84

    The FIRST questionnaire is a 6-item self-questionnaire that detects fibromyalgia.

  3. Evaluation of stress by the heart rate variability

    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.

  4. Assessment Using Numerical Scale (EN)

    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.

  5. Concise Pain Questionnaire (QCD)

    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).

  6. Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B) and the Cantab® test

    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.

  7. Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B)

    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.).

  8. Cantab® test

    Time frame: Day0; Day0+28; Day0+84

    The Cantab® is a comprehension test, executive functions, memory, attention and decision-making.

  9. Evaluation of the emotions by visualization of images and scale evaluating the feelings of the patients

    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).

  10. Evaluation of the overall impression of change by the Patient Global Impression of Change Questionnaire (PGIC)

    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

  11. Evaluation of the impact on the Pittsburg Sleep Quality Index (PSQI)

    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

  12. Evaluation of the intensity of fatigue by the Fatigue Severity Scale (FSS)

    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

  13. Social Vulnerability Assessment (EPICES)

    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.

  14. Evaluation of catastrophism by the PCS (Pain Catastrophizing Scale) scale

    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.

  15. Quality of life (Short Form 12 items Short Form survey)

    Time frame: Day0; Day0+28; Day0+84

    assessed by a quality of life questionnaire (Short Form 12 items Short Form survey (SF12)

  16. Evaluation of the presence of small fiber neuropathy (Sudoscan® )

    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.

  17. Evaluation of the presence of small fiber neuropathy (skin biopsy)

    Time frame: at Day0

    A skin biopsy will be realized for histological analysis to determine the presence of small fiber neuropathy.

  18. plasma magnesium dosage

    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).

  19. erythrocyte magnesium dosage

    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).

  20. urinary magnesium dosage

    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.

  21. urinary magnesium dosage

    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.

  22. creatinine dosage

    Time frame: D0-7

    The creatinine concentrations will be determined by the blood samples taken at the inclusion visit.

  23. Analysis of the microbiota (stool samples)

    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.

  24. Evaluation of genetic polymorphism using OpenArray technology

    Time frame: Day0-7

    Identification of genes involved

  25. Evaluation of stress response during visual stimulation

    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.

  26. Evaluation of pain response during thermal stimulation

    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®).

  27. Evaluation of electromyography (EMG) of median nerve

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • CIC Inserm 1405, University Hospital Clermont-Ferrand, France

Registry information

Official study title

Effect of Magnesium on Stress in Fibromyalgia: Randomized Double-blind Placebo Controlled Trial

Acronym: SeMAFor

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2019
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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