Back to resultsMagnesium, Stress and Fibromyalgia (SeMAFor)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
magnesium
placebo
Sponsored by
About this trial
This is an interventional other trial for Fibromyalgia focused on measuring Fibromyalgia, Stress, Magnesium, Sleep disorders
Eligibility Criteria
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.
Sites / Locations
- Chu Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MAGNESIUM
PLACEBO
Arm Description
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
Outcomes
Primary Outcome Measures
Measure of stress with DASS-42
Measure of stress with stress subscale in magnesium and placebo group. This subscale consists of 14 questions of self-evaluation
Secondary Outcome Measures
Evaluation of the impact of fibromyalgia using the FIQ questionnaire
The revised FIQ questionnaire is a 10-item self-questionnaire that assesses the impact of fibromyalgia
Detection of fibromyalgia using the FIRST questionnaire
The FIRST questionnaire is a 6-item self-questionnaire that detects fibromyalgia.
Evaluation of stress by the heart rate variability
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.
Assessment Using Numerical Scale (EN)
This scale allows the patient to note the pain on a graduation whose minimum score is 0 and the maximum score is 10.
Concise Pain Questionnaire (QCD)
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).
Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B) and the Cantab® test
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.
Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B)
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.).
Cantab® test
The Cantab® is a comprehension test, executive functions, memory, attention and decision-making.
Evaluation of the emotions by visualization of images and scale evaluating the feelings of the patients
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).
Evaluation of the overall impression of change by the Patient Global Impression of Change Questionnaire (PGIC)
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
Evaluation of the impact on the Pittsburg Sleep Quality Index (PSQI)
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
Evaluation of the intensity of fatigue by the Fatigue Severity Scale (FSS)
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
Social Vulnerability Assessment (EPICES)
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.
Evaluation of catastrophism by the PCS (Pain Catastrophizing Scale) scale
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.
Quality of life (Short Form 12 items Short Form survey)
assessed by a quality of life questionnaire (Short Form 12 items Short Form survey (SF12)
Evaluation of the presence of small fiber neuropathy (Sudoscan® )
Sudoscan® (Impeto Medical, Paris, France) is a new device that provides a rapid, non-invasive and reproducible quantitative assessment of sweat function.
Evaluation of the presence of small fiber neuropathy (skin biopsy)
A skin biopsy will be realized for histological analysis to determine the presence of small fiber neuropathy.
plasma magnesium dosage
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).
erythrocyte magnesium dosage
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).
urinary magnesium dosage
The urinary concentration of magnesium will be determined by the urine collected for 24 hours, the day before visits 3 and 4.
urinary magnesium dosage
The urinary concentration of magnesium will be determined by the urine collected for 24 hours, the day before visits 3 and 4.
creatinine dosage
The creatinine concentrations will be determined by the blood samples taken at the inclusion visit.
Analysis of the microbiota (stool samples)
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.
Evaluation of genetic polymorphism using OpenArray technology
Identification of genes involved
Evaluation of stress response during visual stimulation
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.
Evaluation of pain response during thermal stimulation
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®).
Evaluation of electromyography (EMG) of median nerve
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.
Full Information
NCT ID
NCT03887000
First Posted
March 7, 2019
Last Updated
October 22, 2020
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
CIC Inserm 1405, University Hospital Clermont-Ferrand, France
1. Study Identification
Unique Protocol Identification Number
NCT03887000
Brief Title
Magnesium, Stress and Fibromyalgia
Acronym
SeMAFor
Official Title
Effect of Magnesium on Stress in Fibromyalgia: Randomized Double-blind Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
January 12, 2020 (Actual)
Study Completion Date
May 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
CIC Inserm 1405, University Hospital Clermont-Ferrand, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Stress, Magnesium, Sleep disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAGNESIUM
Arm Type
Experimental
Arm Description
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
Arm Title
PLACEBO
Arm Type
Experimental
Arm Description
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
Intervention Type
Other
Intervention Name(s)
magnesium
Intervention Description
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
Primary Outcome Measure Information:
Title
Measure of stress with DASS-42
Description
Measure of stress with stress subscale in magnesium and placebo group. This subscale consists of 14 questions of self-evaluation
Time Frame
at day 0
Secondary Outcome Measure Information:
Title
Evaluation of the impact of fibromyalgia using the FIQ questionnaire
Description
The revised FIQ questionnaire is a 10-item self-questionnaire that assesses the impact of fibromyalgia
Time Frame
Day0; Day0+28; Day0+84
Title
Detection of fibromyalgia using the FIRST questionnaire
Description
The FIRST questionnaire is a 6-item self-questionnaire that detects fibromyalgia.
Time Frame
Day0; Day0+28; Day0+84
Title
Evaluation of stress by the heart rate variability
Description
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
Day0-7; Day0; Day0+28; Day0+84
Title
Assessment Using Numerical Scale (EN)
Description
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
Title
Concise Pain Questionnaire (QCD)
Description
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
Title
Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B) and the Cantab® test
Description
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
Title
Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B)
Description
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
Title
Cantab® test
Description
The Cantab® is a comprehension test, executive functions, memory, attention and decision-making.
Time Frame
Day0; Day0+28; Day0+84
Title
Evaluation of the emotions by visualization of images and scale evaluating the feelings of the patients
Description
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
Title
Evaluation of the overall impression of change by the Patient Global Impression of Change Questionnaire (PGIC)
Description
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
Title
Evaluation of the impact on the Pittsburg Sleep Quality Index (PSQI)
Description
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
Title
Evaluation of the intensity of fatigue by the Fatigue Severity Scale (FSS)
Description
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
Title
Social Vulnerability Assessment (EPICES)
Description
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
Title
Evaluation of catastrophism by the PCS (Pain Catastrophizing Scale) scale
Description
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
Title
Quality of life (Short Form 12 items Short Form survey)
Description
assessed by a quality of life questionnaire (Short Form 12 items Short Form survey (SF12)
Time Frame
Day0; Day0+28; Day0+84
Title
Evaluation of the presence of small fiber neuropathy (Sudoscan® )
Description
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; Day0+28
Title
Evaluation of the presence of small fiber neuropathy (skin biopsy)
Description
A skin biopsy will be realized for histological analysis to determine the presence of small fiber neuropathy.
Time Frame
at Day0
Title
plasma magnesium dosage
Description
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
Title
erythrocyte magnesium dosage
Description
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
Title
urinary magnesium dosage
Description
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; D0+28; D0+84
Title
urinary magnesium dosage
Description
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
Title
creatinine dosage
Description
The creatinine concentrations will be determined by the blood samples taken at the inclusion visit.
Time Frame
D0-7
Title
Analysis of the microbiota (stool samples)
Description
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
24 hours before the visit 2
Title
Evaluation of genetic polymorphism using OpenArray technology
Description
Identification of genes involved
Time Frame
Day0-7
Title
Evaluation of stress response during visual stimulation
Description
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
Title
Evaluation of pain response during thermal stimulation
Description
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
Day0; Day0+28
Title
Evaluation of electromyography (EMG) of median nerve
Description
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.
Time Frame
day 0
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle PICKERING
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Magnesium, Stress and Fibromyalgia
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