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Fibromyalgia is a disease that significantly decreases the quality of life of people who suffer from it, has great repercussions at the socio-economic level due to the incapacity it produces. It is characterized by generalized pain, fatigue, sleep disorders, psychological stress and mental alterations, besides presenting painful points in different parts of the body to physical examination. Having few effective treatments is necessary to explore new options in their management to improve the general conditions of the patient. Previous studies have shown that patients with fibromyalgia have had low levels of vitamin D in the blood, a favorable response from post-vitamin D supplementation has been seen. This vitamin has been associated with pain pathways and with increased The perception of the same when it is in smaller amount. We will select patients with Fibromyalgia diagnosis from the external consultation of Rheumatology of the University Hospital "Dr. José Eleuterio González "of the UANL, over 18 years old who have not been previously supplemented with vitamin D, will initially be measured in blood of vitamin D, in addition to calcium as a safety measure, we will have a group that will only receive placebo and Another that will be supplemented with 50 thousand units weekly for 12 weeks, we will apply a questionnaire that measures pain scale and another one that measures the impact of the disease in the daily life of the patient, this will be done in a beginning and at the end of the 12 weeks .
Full description
Fibromyalgia is a disease characterized mainly by generalized pain, with great repercussion in the patient's quality of life as well as in his work and social performance. There are different therapies that have not been totally effective for the management of this pathology, for that reason it is necessary to look for cost-effective options and the reach of all the patients to obtain remission of the symptoms.
Fibromyalgia affects 1-4% of the general population, patients manifest chronic pain and other comorbidities such as sleep disorders, fatigue, depression, psychological stress and cognitive disturbances. It is a significant cause of loss of employment and disconnection from the social environment.
A longitudinal, prospective, randomized study with patients diagnosed with Fibromyalgia will be performed at the outpatient clinic of the Rheumatology Service at the University Hospital "Dr. José Eleuterio González "of the Autonomous University of Nuevo León.
DEFINITION OF VARIABLES
Dependent variable:
Vitamin D levels Conceptual definition: it is considered as pro-hormone, its active metabolite 1-25-dihydroxyvitamin D functions as a hormone since it has its own receptors found in all human cells.4 Operational definition: Normal levels> 30-100 ng / ml, 10-30 ng / ml insufficiency and a deficit <10 ng / ml as defined by the laboratory.19 Measurement scale: qualitative.
Independent variables:
Fibromyalgia Impact Questionnaire (FIQ) Conceptual definition: a questionnaire that assesses the impact of FM in physical capacity, the possibility of doing the usual work and, in the case of performing a paid work, the degree to which FM has affected this activity as well As subjective items very related to the FM picture (pain, fatigue, tiredness and stiffness) and emotional state (anxiety and depression).
Operational definition: consists of three domains functionality, global impact and symptomatology. It consists of 10 items. The first is the only one containing several sub-items (a-j), in number of 10, each with a rank of 4 points (from 0, always, to 3, never) according to a Likert scale.
This item evaluates the functional capacity of the patient through questions about activities related to daily life: buy, drive, etc. The second and third items correspond to numerical scales that refer to days of the week: the second on a scale from 1 to 7, and the third from 1 to 5. The rest of the items are valued using analog visual scales (EVA) From 0 to 10.
Type of variable: Quantitative dichotomous.
Visual Analogue Scale (VAS) Conceptual definition: approach used to measure pain. In one line the patient scores a point that best describes the intensity of his pain.
Operational definition: a scale that allows to measure the intensity of pain, draws a line that divides from 0 to 10, on the left corresponds to the use of pain with the number 0, on the right is the maximum degree of pain corresponds to 10 .
Type of variable: quantitative
Other variables:
Age Conceptual definition: Time that has lived a person counting since birth. Operational definition: Age expressed in years according to the clinical file. Type of variable: quantitative.
Gender Conceptual definition: set of people or things that has common general characteristics.
Operational definition: male and female according to the clinical file. Type of variable: Qualitative.
C-reactive protein (CRP) Conceptual definition: plasma protein or acute phase reactant that rises during inflammatory processes.
Operational definition: it was considered elevated when its levels exceeded 1 mg / dl as it marks the laboratory. It was taken as positive or negative according to this commented level.
Erythrocyte sedimentation rate (ESR) Conceptual definition: acute phase reactant, measures the time it takes erythrocytes to fall or decant in a period of time. It is elevated in inflammatory, infectious and neoplastic processes.
Operational definition: elevated ESR levels were considered according to the formula adjusted for age in men = age / 2, for women = age + 10/2.
MEASUREMENT TOOLS
Fibromyalgia Impact Questionnaire (FIQ) Questionnaire that measures the impact that Fibromialgia has on the daily life of the patient. It is responsible for evaluating three items: functionality of the subject, overall impact of the disease and symptomatology. It was developed in 1980 by Drs. Carol Burckhardt, Sharon Clark and Robert Bennett Portland, Oregon USA. Published 1991, revisions 1997 - 2002 - 2009. It is one of the most used tools for evaluation of patients with FM. It consists of 10 items. The first is the only one containing several sub-items (a-j), in number of 10, each with a rank of 4 points (from 0, always, to 3, never) according to a Likert scale. This item evaluates the functional capacity of the patient through questions about activities related to daily life: buy, drive, etc. The second and third items correspond to numerical scales that refer to days of the week: the second on a scale from 1 to 7, and the third from 1 to 5. The rest of the items are valued using visual analogue scale (VAS) From 0 to 10. It was validated by Monterde in 2004.
Visual Analog Scale (VAS) Scale that allows to measure the intensity of pain, draws a line that divides from 0 to 10, on the left corresponds to the use of pain with the number 0, on the right is the maximum degree of pain corresponds to 10.
Mini Neuro-Psychiatric Interview It is a brief and highly structured interview of the major psychiatric disorders of ICD-10 and DSM-IV. It was elaborated by Y. Lecrubier et al. Of the "Salpétrére" of Paris and D. Scheehan et al. Of the University of Tampa Florida in 1992, 1994 and 1998. It serves to diagnose depressions, phobias, suicides, generalized anxiety disorders, agoraphobia, substance abuse or dependence. A tool of great utility in primary care.
SAMPLE SIZE:
According to Young's nomogram for sample size calculation for controlled clinical trials (with an alpha of 0.05 and statistical power of 0.8), the sample size (including a 20% to compensate for possible losses) by study group is : 80 patients.
SAMPLING TECHNIQUE:
Patients were selected using a non-probabilistic sampling technique for consecutive cases.
STATISTIC ANALYSIS:
The t-test for independent samples and logistic regression will be used to evaluate the effect of the independent variables on the dependent variable. A value of p ≤ 0.05 shall be considered significant. The statistical package SPSS version 17.0 for Windows 7 will be used.
METHODS Allocation method: Consecutive incident patients will be included, those eligible for the study will be assigned to treatment groups using a pre-established allocation table, which was generated in the randomization module of the True Epistat statistical program.
DESCRIPTION OF THE STUDY
DATA COLLECTION SYSTEM A patient file will be included (Case report form). Finally, the data will be transferred to the database and analyzed with the SPSS program for Windows 7 version 17.0.
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80 participants in 2 patient groups, including a placebo group
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