Discomfort and Psychosocial Difficulties in Fibromyalgia

Phase 4

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Psychology therapy; Drug: Botox infiltration; Other: Botox infiltration & psychology therapy

• Registration Number: NCT02078791
• Lead Sponsor: University Rovira i Virgili

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).

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-09
• Study Completion: 2014-02
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychology therapy	Psychology therapy	Problem solving group therapy
Botox infiltration	Botox infiltration	Botox infiltration in cervical region
Botox infiltration & psychology therapy	Botox infiltration & psychology therapy	Botox infiltration in cervical region and problem solving group therapy.

Primary Outcome Measures

Name	Time	Method
Change in pain perception Visual Analogical Scale (VAS)	Baseline and 2 months

Secondary Outcome Measures

Name	Time	Method
Change in suicidal thoughts Plutchick Scale	Baseline and 2 months
change in quality of sleep SCOPA questionnaire	Baseline and 2 months
Change in health questionnaire EQ5D5L	Baseline and 2 months

Trial Locations

Locations (1)

Hospital Verge de la Cinta; 🇪🇸 Tortosa, Tarragona, Spain