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
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Botox infiltration Behavioral: Psychology therapy Other: Botox infiltration & psychology therapy||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Change in pain perception Visual Analogical Scale (VAS) [ Time Frame: Baseline and 2 months ]
- Change in suicidal thoughts Plutchick Scale [ Time Frame: Baseline and 2 months ]
- change in quality of sleep SCOPA questionnaire [ Time Frame: Baseline and 2 months ]
- Change in health questionnaire EQ5D5L [ Time Frame: Baseline and 2 months ]
- Change in satisfaction and perceived usefulness questionnaire [ Time Frame: Baseline and 2 months ]
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
|Hospital Verge de la Cinta|
|Tortosa, Tarragona, Spain, 43500|
|Study Director:||PILAR MONTESÓ, phD||Rovira i Virgili University|