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Discomfort and Psychosocial Difficulties in Fibromyalgia (Fibroebre)

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ClinicalTrials.gov Identifier: NCT02078791
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : September 16, 2014
Sponsor:
Collaborators:
Catalan Institute of Health
Universidad Nacional de Educación a Distancia
Information provided by (Responsible Party):
Pilar Montesó Curto, University Rovira i Virgili

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Botox infiltration Behavioral: Psychology therapy Other: Botox infiltration & psychology therapy Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perception of Discomfort and Psychosocial Difficulties in People With Diagnosis of Fibromyalgia and Predominant Neck Pain
Study Start Date : July 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Fibromyalgia

Arm Intervention/treatment
Experimental: Botox infiltration
Botox infiltration in cervical region
Drug: Botox infiltration
botox cervical infiltration in a group
Other Name: 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 Name: 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 Name: Botox infiltration and problem solving group therapy.




Primary Outcome Measures :
  1. Change in pain perception Visual Analogical Scale (VAS) [ Time Frame: Baseline and 2 months ]

Secondary Outcome Measures :
  1. Change in suicidal thoughts Plutchick Scale [ Time Frame: Baseline and 2 months ]
  2. change in quality of sleep SCOPA questionnaire [ Time Frame: Baseline and 2 months ]
  3. Change in health questionnaire EQ5D5L [ Time Frame: Baseline and 2 months ]

Other Outcome Measures:
  1. Change in satisfaction and perceived usefulness questionnaire [ Time Frame: Baseline and 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078791


Locations
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Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, Spain, 43500
Sponsors and Collaborators
University Rovira i Virgili
Catalan Institute of Health
Universidad Nacional de Educación a Distancia
Investigators
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Study Director: PILAR MONTESÓ, phD Rovira i Virgili University

Additional Information:
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Responsible Party: Pilar Montesó Curto, Dr., University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT02078791     History of Changes
Other Study ID Numbers: 2012LINE-01
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

Keywords provided by Pilar Montesó Curto, University Rovira i Virgili:
Fibromyalgia
Group Problem Solving Technique
infiltration

Additional relevant MeSH terms:
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Botulinum Toxins, Type A
abobotulinumtoxinA
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents