Clinical trial NCT02078791: Discomfort and Psychosocial Difficulties in Fibromyalgia
Official title: Perception of Discomfort and Psychosocial Difficulties in People With Diagnosis of Fibromyalgia and Predominant Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Group Problem Solving Technique
infiltration
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Catalan Institute of Health
name: Universidad Nacional de Educación a Distancia
First posted: 2014-03-05
Enrollment: 66
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Diagnosing Fibromyalgia.
* Diagnosing Fibromyalgia + other causative pathology of chronic pain (chronic and / or chronic low back pain neck pain).
* Acceptance of study participation by informed consent

Exclusion Criteria:

* Severe disability that makes a first indication infiltration (disc herniation and / or lumbar spinal stenosis).
* cognitive Impairment
* Life expectancy less than 12 months

Primary outcomes:
measure: Change in pain perception Visual Analogical Scale (VAS)
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Change in suicidal thoughts Plutchick Scale
timeFrame: Baseline and 2 months
measure: change in quality of sleep SCOPA questionnaire
timeFrame: Baseline and 2 months
measure: Change in health questionnaire EQ5D5L
timeFrame: Baseline and 2 months
Other outcomes:
measure: Change in satisfaction and perceived usefulness questionnaire
timeFrame: Baseline and 2 months
Locations:
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili
name: PILAR MONTESÓ, phD
role: STUDY_DIRECTOR
References: