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Discomfort and Psychosocial Difficulties in Fibromyalgia

Perception of Discomfort and Psychosocial Difficulties in People With Diagnosis of Fibromyalgia and Predominant Neck Pain

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02078791
Acronym
Fibroebre
Enrollment
66
Registered
2014-03-05
Start date
2012-07-31
Completion date
2014-02-28
Last updated
2014-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Group Problem Solving Technique, infiltration

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).

Interventions

DRUGBotox infiltration

botox cervical infiltration in a group

Psychology problem solving therapy lead by specialized nurses.

OTHERBotox infiltration & psychology therapy

Botox infiltration in cervical region and psychology problem solving therapy lead by specialized nurses.

Sponsors

Catalan Institute of Health
CollaboratorOTHER_GOV
Universidad Nacional de Educación a Distancia
CollaboratorOTHER
University Rovira i Virgili
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in pain perception Visual Analogical Scale (VAS)Baseline and 2 months

Secondary

MeasureTime frame
Change in suicidal thoughts Plutchick ScaleBaseline and 2 months
change in quality of sleep SCOPA questionnaireBaseline and 2 months
Change in health questionnaire EQ5D5LBaseline and 2 months

Other

MeasureTime frame
Change in satisfaction and perceived usefulness questionnaireBaseline and 2 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026