Fibromyalgia Clinical Trial
Official title:
Perception of Discomfort and Psychosocial Difficulties in People With Diagnosis of Fibromyalgia and Predominant Neck Pain
The patients who were not pain control, are referred to the Chronic Pain Unit so its complexity is greater. Made two different interventions in three groups of people with fibromyalgia. In the first group will proceed to infiltrate the painful area with medication, in the second GPST (Group Problem Solving Technique) and the third group both techniques. GPST will want to identify problems that people associate with fibromyalgia, as well as proposed solutions and it they have been carried out successfully or not. Will be essential to identifying and solving problems and using techniques to increase assertiveness, self-esteem and eliminating negative thoughts. Observing if after performing any of these techniques (infiltration, GPST or both) there is a better quality of life, reduce thoughts of suicide, pain and improves sleep quality. We also analyzed the satisfaction or not with therapies received and perceived usefulness.
It is a clinical trial. STUDY SUBJECTS. By random sampling will distribute women diagnosed
with fibromyalgia in three groups. 30 people are expected to include in each of the three
groups. Group 1. Infiltration, GPST Group 2, Group 3 GPST+ Infiltration The sample size is
approximately 30 so that alpha risk of 0.05, and a lower risk beta 0.2, 29 subjects needed
to detect a difference equal to or greater than 0.25 units. It is assumed that the
proportion in the control group is 0.8. has estimated a loss rate of 20% follow-up.
Fibromyalgia patients attending the chronic pain unit referred by family doctors and other
specialists. These are patients who have painful symptoms that could not be controlled in
the first level of health care or health centers.Not form part of the study all patients
with fibromyalgia but only those who have discomfort in the cervical area preferably.To
include in the study the patient acceptance of its participation is required by informed
consent.Anesthesiologists assigned patients into three different groups according to the
intervention takes place; infiltration, TRP (Problem Solving Therapy) or both interventions.
When patients have met 8-10 start TRP group. Each group will be directed by a trained
professional nursing. If we if we haven't enough sample will search in Fibromyalgia
Associations.
The information of all variables are entered into a database (Excel) of which will be
imported to a statistical program (SPSS) for analysis.
Qualitative variables were expressed as frequencies and percentages and quantitative
mediated by central tendency and (mean and standard deviation) dispersion.The relationship
between variables was analyzed by the χ2, comparison of means (t-student), analysis of
variance (ANOVA) and Spearman, depending on the type of variable.Multivariate analysis will
be performed to try to determine factors that may promote improved quality of life /
patients.
It is considered that the difference between variables is significant when the significance
level is less than or equal to 0.05 (p ≤ 0.05).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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