Discomfort and Psychosocial Difficulties in Fibromyalgia

NCT ID: NCT02078791

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-02-28

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).

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botox infiltration

Botox infiltration in cervical region

Group Type: EXPERIMENTAL

Botox infiltration

Intervention Type: DRUG

botox cervical infiltration in a group

Psychology therapy

Problem solving group therapy

Group Type: EXPERIMENTAL

Psychology therapy

Intervention Type: BEHAVIORAL

Psychology problem solving therapy lead by specialized nurses.

Botox infiltration & psychology therapy

Botox infiltration in cervical region and problem solving group therapy.

Group Type: EXPERIMENTAL

Botox infiltration & psychology therapy

Intervention Type: OTHER

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

Interventions

Botox infiltration

botox cervical infiltration in a group

Intervention Type: DRUG

Psychology therapy

Psychology problem solving therapy lead by specialized nurses.

Intervention Type: BEHAVIORAL

Botox infiltration & psychology therapy

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

Intervention Type: OTHER

Other Intervention Names

botox infiltration, and grup solving terapy group; Problem solving group therapy; Botox infiltration and problem solving group therapy.

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catalan Institute of Health

OTHER_GOV

Sponsor Role: collaborator

Universidad Nacional de Educación a Distancia

OTHER

Sponsor Role: collaborator

University Rovira i Virgili

OTHER

Sponsor Role: lead

Responsible Party

Pilar Montesó Curto

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

PILAR MONTESÓ, phD

Role: STUDY_DIRECTOR

University Rovira i Virgili

Locations

Hospital Verge de la Cinta

Tortosa, Tarragona, Spain

Countries

Spain

Related Links

http://www.fibromyalgia.org

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

Other Identifiers

2012LINE-01

Identifier Type: -

Identifier Source: org_study_id