Discomfort and Psychosocial Difficulties in Fibromyalgia (Fibroebre)

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Botox infiltration; Behavioral: Psychology therapy; Other: Botox infiltration & psychology therapy

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Tortosa, Tarragona, Spain, 43500
      • Hospital Verge de la Cinta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botox infiltration; Botox infiltration in cervical region	Drug: Botox infiltration; botox cervical infiltration in a group; Other Names: botox infiltration, and grup solving terapy group
Experimental: Psychology therapy; Problem solving group therapy	Behavioral: Psychology therapy; Psychology problem solving therapy lead by specialized nurses.; Other Names: Problem solving group therapy
Experimental: Botox infiltration & psychology therapy; Botox infiltration in cervical region and problem solving group therapy.	Other: Botox infiltration & psychology therapy; Botox infiltration in cervical region and psychology problem solving therapy lead by specialized nurses.; Other Names: Botox infiltration and problem solving group therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in pain perception Visual Analogical Scale (VAS)	Baseline and 2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Change in satisfaction and perceived usefulness questionnaire	Baseline and 2 months

Collaborators and Investigators

• Sponsor: University Rovira i Virgili
• Collaborators: Catalan Institute of Health; Universidad Nacional de Educación a Distancia
• Investigators: Study Director: PILAR MONTESÓ, phD, Rovira i Virgili University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): September 16, 2014
• Last Update Submitted That Met QC Criteria: September 15, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Fibromyalgia; Group Problem Solving Technique; infiltration
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2012LINE-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No