Discomfort and Psychosocial Difficulties in Fibromyalgia (Fibroebre)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Botox infiltration
Psychology therapy
Botox infiltration & psychology therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Group Problem Solving Technique, infiltration
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
Sites / Locations
- Hospital Verge de la Cinta
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Botox infiltration
Psychology therapy
Botox infiltration & psychology therapy
Arm Description
Botox infiltration in cervical region
Problem solving group therapy
Botox infiltration in cervical region and problem solving group therapy.
Outcomes
Primary Outcome Measures
Change in pain perception Visual Analogical Scale (VAS)
Secondary Outcome Measures
Change in suicidal thoughts Plutchick Scale
change in quality of sleep SCOPA questionnaire
Change in health questionnaire EQ5D5L
Full Information
NCT ID
NCT02078791
First Posted
February 27, 2014
Last Updated
September 15, 2014
Sponsor
University Rovira i Virgili
Collaborators
Catalan Institute of Health, Universidad Nacional de Educación a Distancia
1. Study Identification
Unique Protocol Identification Number
NCT02078791
Brief Title
Discomfort and Psychosocial Difficulties in Fibromyalgia
Acronym
Fibroebre
Official Title
Perception of Discomfort and Psychosocial Difficulties in People With Diagnosis of Fibromyalgia and Predominant Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Rovira i Virgili
Collaborators
Catalan Institute of Health, Universidad Nacional de Educación a Distancia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Group Problem Solving Technique, infiltration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botox infiltration
Arm Type
Experimental
Arm Description
Botox infiltration in cervical region
Arm Title
Psychology therapy
Arm Type
Experimental
Arm Description
Problem solving group therapy
Arm Title
Botox infiltration & psychology therapy
Arm Type
Experimental
Arm Description
Botox infiltration in cervical region and problem solving group therapy.
Intervention Type
Drug
Intervention Name(s)
Botox infiltration
Other Intervention Name(s)
botox infiltration, and grup solving terapy group
Intervention Description
botox cervical infiltration in a group
Intervention Type
Behavioral
Intervention Name(s)
Psychology therapy
Other Intervention Name(s)
Problem solving group therapy
Intervention Description
Psychology problem solving therapy lead by specialized nurses.
Intervention Type
Other
Intervention Name(s)
Botox infiltration & psychology therapy
Other Intervention Name(s)
Botox infiltration and problem solving group therapy.
Intervention Description
Botox infiltration in cervical region and psychology problem solving therapy lead by specialized nurses.
Primary Outcome Measure Information:
Title
Change in pain perception Visual Analogical Scale (VAS)
Time Frame
Baseline and 2 months
Secondary Outcome Measure Information:
Title
Change in suicidal thoughts Plutchick Scale
Time Frame
Baseline and 2 months
Title
change in quality of sleep SCOPA questionnaire
Time Frame
Baseline and 2 months
Title
Change in health questionnaire EQ5D5L
Time Frame
Baseline and 2 months
Other Pre-specified Outcome Measures:
Title
Change in satisfaction and perceived usefulness questionnaire
Time Frame
Baseline and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PILAR MONTESÓ, phD
Organizational Affiliation
University Rovira i Virgili
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Verge de la Cinta
City
Tortosa
State/Province
Tarragona
ZIP/Postal Code
43500
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.fibromyalgia.org
Description
Click here for more information about this study: Clinical Trial of Fibromyalgya in Southern Catalonia
Learn more about this trial
Discomfort and Psychosocial Difficulties in Fibromyalgia
We'll reach out to this number within 24 hrs