FibromyalgiaPhase 4FibroebreNCT02078791
Discomfort and Psychosocial Difficulties in Fibromyalgia
A Phase 4 study testing Botox infiltration, Psychology therapy and Botox infiltration & psychology therapy in people with Fibromyalgia, run by University Rovira i Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Botox infiltration, Psychology therapy and Botox infiltration & psychology therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2012to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe disability that makes a first indication infiltration (disc herniation and / or lumbar spinal stenosis).
- cognitive Impairment
- Life expectancy less than 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Botox infiltration, Psychology therapy, Botox infiltration & psychology therapy
- Keywords
- Fibromyalgia, Group Problem Solving Technique, infiltration
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox infiltrationDrug
Also called botox infiltration, and grup solving terapy group
botox cervical infiltration in a group
Psychology therapyBehavioural
Also called Problem solving group therapy
Psychology problem solving therapy lead by specialized nurses.
Botox infiltration & psychology therapyOther
Also called Botox infiltration and problem solving group therapy.
Botox infiltration in cervical region and psychology problem solving therapy lead by specialized nurses.
| Study group | Role | What they receive |
|---|---|---|
| Botox infiltration | Experimental | Botox infiltration in cervical region Receives: Drug: Botox infiltration |
| Psychology therapy | Experimental | Problem solving group therapy Receives: Behavioral: Psychology therapy |
| Botox infiltration & psychology therapy | Experimental | Botox infiltration in cervical region and problem solving group therapy. Receives: Other: Botox infiltration & psychology therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain perception Visual Analogical Scale (VAS)
Measured: Baseline and 2 months
Secondary outcomes (3)
Change in suicidal thoughts Plutchick Scale
Measured: Baseline and 2 months
change in quality of sleep SCOPA questionnaire
Measured: Baseline and 2 months
Change in health questionnaire EQ5D5L
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJul 2012
- Primary completionSep 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Catalan Institute of Health, Universidad Nacional de Educación a Distancia
- Responsible party
- Principal investigator, Pilar Montesó Curto, University Rovira i Virgili
- Investigators
- PILAR MONTESÓ, phD, Study director, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078791
- Sponsor's protocol ID
- 2012LINE-01
- Acronym
- Fibroebre
- Status last verified
- Sep 2014
- First submitted
- 27 Feb 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Discomfort and Psychosocial Difficulties in People With Diagnosis of Fibromyalgia and Predominant Neck Pain
- ClinicalTrials.gov ID
- NCT02078791
- Acronym / sponsor ID
- Fibroebre / 2012LINE-01
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Group Problem Solving Technique, infiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Catalan Institute of Health, Universidad Nacional de Educación a Distancia
- Study start
- Jul 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botox infiltration | Experimental | Drug: Botox infiltrationBotox infiltration in cervical region |
| Psychology therapy | Experimental | Behavioral: Psychology therapyProblem solving group therapy |
| Botox infiltration & psychology therapy | Experimental | Other: Botox infiltration & psychology therapyBotox infiltration in cervical region and problem solving group therapy. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Severe disability that makes a first indication infiltration (disc herniation and / or lumbar spinal stenosis).
- cognitive Impairment
- Life expectancy less than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox infiltrationAlso: botox infiltration, and grup solving terapy groupbotox cervical infiltration in a group | Drug | Botox infiltration |
| Psychology therapyAlso: Problem solving group therapyPsychology problem solving therapy lead by specialized nurses. | Behavioural | Psychology therapy |
| Botox infiltration & psychology therapyAlso: Botox infiltration and problem solving group therapy.Botox infiltration in cervical region and psychology problem solving therapy lead by specialized nurses. | Other | Botox infiltration & psychology therapy |
Primary outcome
Change in pain perception Visual Analogical Scale (VAS)
Time frame: Baseline and 2 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
- Click here for more information about this study: Clinical Trial of Fibromyalgya in Southern CataloniaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PILAR MONTESÓ, phD study director
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botox infiltration, Psychology therapy and Botox infiltration & psychology therapy in people with Fibromyalgia, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain perception Visual Analogical Scale (VAS) (time frame: Baseline and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.