Discomfort and Psychosocial Difficulties in Fibromyalgia

Fibromyalgia Clinical Trial

— Fibroebre  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078791
• Other study ID #: 2012LINE-01
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2014
• Last updated: September 15, 2014
• Start date: July 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Botox infiltration
botox cervical infiltration in a group

Behavioral:
• Psychology therapy
Psychology problem solving therapy lead by specialized nurses.

Other:
• Botox infiltration & psychology therapy
Botox infiltration in cervical region and psychology problem solving therapy lead by specialized nurses.

Locations

Country	Name	City	State
Spain	Hospital Verge de la Cinta	Tortosa	Tarragona

Sponsors (3)

Lead Sponsor	Collaborator
University Rovira i Virgili	Catalan Institute of Health, Universidad Nacional de Educación a Distancia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in satisfaction and perceived usefulness questionnaire		Baseline and 2 months	No
Primary	Change in pain perception Visual Analogical Scale (VAS)		Baseline and 2 months	No
Secondary	Change in suicidal thoughts Plutchick Scale		Baseline and 2 months	No
Secondary	change in quality of sleep SCOPA questionnaire		Baseline and 2 months	No
Secondary	Change in health questionnaire EQ5D5L		Baseline and 2 months	No

External Links

•   Click here for more information about this study: Clinical Trial of Fibromyalgya in Southern Catalonia