FibromyalgiaNCT03673553
The Multidisciplinary Treatment of Fibromyalgia.
An observational study of Fibromyalgia and Pain, run by Institut Investigacio Sanitaria Pere Virgili.
Trial summary
Background Fibromyalgia is a pathology characterised by chronic pain that harms people's quality of life. This pathology requires an MRT that combines pharmacological and non-pharmacological treatments. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Fibromyalgia, Pain, Treatment
- What is being tested?
- Multimodal treatment of patients with FM and Association of people with fibromyalgia
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2016to 15 Jun 2017
- How long will I take part?
- 10 Weeks
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample size was calculated on the basis of accepting an alpha risk of less than 0.05 and a beta risk of less than 0.20. The calculation indicated that 23 subjects each in the intervention and control groups were needed to detect a minimum clinically significant difference greater than or equal to 8.1 points in the FIQ score. A common standard deviation of 9.6 was assumed, and a rate of loss to follow-up of 0% was estimated, since there were no losses during sample recruitment. The chosen standard deviation was that used by Lera (2009)
Eligibility Criteria inclusion intervention group:
- to be diagnosed with FM
- to be between 18 and 80 years old
- be a patient of the unit care of FM
- the patients have to participate in nine of the treatment sessions
- the patients have to make the first visit in the unit care of FM during 2016
Eligibility Criteria inclusion control group:
- to be diagnosed with FM
- to be between 18 and 80 years old
- to be a member of the FM Patient Association of Terres de l'Ebre
Eligibility Criteria exclusion control intervention and group:
- not understanding Catalan or Spanish
- not providing correct contact data
About this study
Official title: The Unite Care of Fibromyalgia. The Experience of the Patients and the Professionals.
Background Fibromyalgia is a pathology characterised by chronic pain that harms people's quality of life. This pathology requires an MRT that combines pharmacological and non-pharmacological treatments. Currently, FPAs are important to society not only by offering activities that improve fibromyalgia symptomatology but also by increasing public awareness of the disease. The present study compares the effectiveness of a multimodal rehabilitation treatment (MRT) with that of the activities of a fibromyalgia patient association (FPA), and identifies the patient characteristics that can interfere with the success of interventions.
Methods The quasi-experimental study selected forty-six older adults with fibromyalgia. The intervention group (n = 23) received pharmacological treatment, physical exercise, education, psychological therapies and Caycedian sophrology, while the control group (n = 23) carried out group psychological sessions and handicraft-based activities. Data collection included sociodemographic measures and responses to the Fibromyalgia Impact Questionnaire (FIQ). Participants were assessed pre- and post-intervention.
Read the detailed description
A descriptive analysis of the sociodemographic characteristics of the intervention and control groups was done. Qualitative variables were expressed as percentages, and quantitative variables were summarised as the median and interquartile range.
Shapiro-Wilk tests indicated that the dependent variables were not normally distributed (p < .05), so non-parametric statistical analyses were subsequently performed. The difference between the medians of the two patient groups was examined with the Mann-Whitney U test. Qualitative variables were compared with the chi-squared or Fisher's exact test, as appropriate.
Being a quasi-experimental study, without randomization of patients, the existence of initial pre-intervention differences in the dimensions evaluated by the FIQ scale between the two patient groups was tested with the Mann-Whitney U test. For the dimensions that showed significant pre-intervention group differences, the medians of the post- and pre-intervention differences between the two patient groups were tested. For those dimensions of the FIQ that showed no pre-intervention differences, the post-intervention values were compared. The changes in the FIQ score and its dimensions before and after the intervention in both groups were assessed using the Wilcoxon test.
Additionally, we carried out univariate and multivariate logistic regression analyses to identify the relationships between the independent variables studied and the improvement variable (increase, or not, of at least 8.1 points in the FIQ score after the intervention).
Finally, the sample was stratified by educational level (primary versus secondary/university studies) and age (younger than 60 years or 60+ years). The pre- and post-intervention scores were compared using the Mann-Whitney U test and the differences in each group were analysed with the Wilcoxon test.
- Conditions
- Fibromyalgia, Pain, Treatment, Quality of Life
- Being tested
- Multimodal treatment of patients with FM, Association of people with fibromyalgia
- Keywords
- fibromyalgia, pain, quality of life, multidomal treatment
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal treatment of patients with FMOther
The intervention group took part in 2.5-hour sessions of MRT once a week for 10 weeks. This intervention combined physical exercise with stretching. Health education was geared towards pain management, the pathology itself, healthy habits, insomnia, postural correction and ergonomics. The psychological approaches used in the MRT were problem-solving therapy, cognitive behavioural therapy and sophrology. Given the diversity of the sessions, they were directed by a rheumatologist, a nurse, a psychologist, and a physiotherapist. If the patient needed their pharmacological treatment to be altered, they were offered an appointment with the rheumatologist.
Association of people with fibromyalgiaOther
The control group attended the activities organised by the association of people with FMS. These consisted of a weekly 1-hour session of group psychology and a weekly 2-hour session of handicrafts for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Association of people with fibromyalgia | Control group included people affiliated to the FM Patient Association of Terres de l'Ebre, Spain. Receives: Other: Association of people with fibromyalgia | |
| Multimodal treatment of patients with FM | The intervention group was made up of patients from the specialist FM Unit in the Hospital of Lleida, Spain. Receives: Other: Multimodal treatment of patients with FM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia impact questionnaire-FIQ
FIQ has been validated for the Spanish population. It is a tool for evaluating the impact of FM on physical capacity and quality of life. FIQ scores range: 0 (best functional capacity and quality of life) to 100 (worst state of health). FIQ scores less than 39 are considered to represent a level of slight deterioration, those between 39 and 59 represent moderate deterioration, and scores greater than 59 imply a severe level of disability. The scale comprises 10 items. The first evaluates functional capacity on an ordinal scale from 0(always) to 3(never). The second and third items are numerical scales that evaluate the number of days that participants have been in a good state of health and the number of days in the week on which they have been able to go to do their normal paid work. The other seven items are rated on analogue scales from 0-10 that measure (i)capacity to do a job, (ii)pain, (iii)fatigue, (iv)morning stiffness, (v)muscular numbness, (vi)anxiety and (vii)depression.
Measured: At the begining of the enrolment and 10 weeks later
Secondary outcomes (1)
Sociodemographic measures
sex, age, civil status, number of children, employment status and level of education. The clinical variables analysed covered the consumption of medication, the number of years that patients had been suffering the symptoms of FMS and the number of years since they had been diagnosed with FMS.
Measured: At the begining of the enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start31 Jan 2016
- Primary completion31 Aug 2016
- Study completion15 Jun 2017
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Verge Cinta_Carlos Lopez, Institut Investigacio Sanitaria Pere Virgili
- Investigators
- ANNA LLADSER NAVARRO, NR, MsC, Principal investigator, Institut Investigacio Sanitaria Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673553
- Sponsor's protocol ID
- CEIC-1488
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2018
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Unite Care of Fibromyalgia. The Experience of the Patients and the Professionals.
- ClinicalTrials.gov ID
- NCT03673553
- Acronym / sponsor ID
- CEIC-1488
- Conditions
- Fibromyalgia, Pain, Treatment, Quality of Life
- Keywords
- fibromyalgia, pain, quality of life, multidomal treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 31 Jan 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 17 Sep 2018 (actual)
- 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.
Background Fibromyalgia is a pathology characterised by chronic pain that harms people's quality of life. This pathology requires an MRT that combines pharmacological and non-pharmacological treatments. Currently, FPAs are important to society not only by offering activities that improve fibromyalgia symptomatology but also by increasing public awareness of the disease. The present study compares the effectiveness of a multimodal rehabilitation treatment (MRT) with that of the activities of a fibromyalgia patient association (FPA), and identifies the patient characteristics that can interfere with the success of interventions.
Methods The quasi-experimental study selected forty-six older adults with fibromyalgia. The intervention group (n = 23) received pharmacological treatment, physical exercise, education, psychological therapies and Caycedian sophrology, while the control group (n = 23) carried out group psychological sessions and handicraft-based activities. Data collection included sociodemographic measures and responses to the Fibromyalgia Impact Questionnaire (FIQ). Participants were assessed pre- and post-intervention.
Detailed description
A descriptive analysis of the sociodemographic characteristics of the intervention and control groups was done. Qualitative variables were expressed as percentages, and quantitative variables were summarised as the median and interquartile range.
Shapiro-Wilk tests indicated that the dependent variables were not normally distributed (p < .05), so non-parametric statistical analyses were subsequently performed. The difference between the medians of the two patient groups was examined with the Mann-Whitney U test. Qualitative variables were compared with the chi-squared or Fisher's exact test, as appropriate.
Being a quasi-experimental study, without randomization of patients, the existence of initial pre-intervention differences in the dimensions evaluated by the FIQ scale between the two patient groups was tested with the Mann-Whitney U test. For the dimensions that showed significant pre-intervention group differences, the medians of the post- and pre-intervention differences between the two patient groups were tested. For those dimensions of the FIQ that showed no pre-intervention differences, the post-intervention values were compared. The changes in the FIQ score and its dimensions before and after the intervention in both groups were assessed using the Wilcoxon test.
Additionally, we carried out univariate and multivariate logistic regression analyses to identify the relationships between the independent variables studied and the improvement variable (increase, or not, of at least 8.1 points in the FIQ score after the intervention).
Finally, the sample was stratified by educational level (primary versus secondary/university studies) and age (younger than 60 years or 60+ years). The pre- and post-intervention scores were compared using the Mann-Whitney U test and the differences in each group were analysed with the Wilcoxon test.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Association of people with fibromyalgia | – | Other: Association of people with fibromyalgiaControl group included people affiliated to the FM Patient Association of Terres de l'Ebre, Spain. |
| Multimodal treatment of patients with FM | – | Other: Multimodal treatment of patients with FMThe intervention group was made up of patients from the specialist FM Unit in the Hospital of Lleida, Spain. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size was calculated on the basis of accepting an alpha risk of less than 0.05 and a beta risk of less than 0.20. The calculation indicated that 23 subjects each in the intervention and control groups were needed to detect a minimum clinically significant difference greater than or equal to 8.1 points in the FIQ score. A common standard deviation of 9.6 was assumed, and a rate of loss to follow-up of 0% was estimated, since there were no losses during sample recruitment. The chosen standard deviation was that used by Lera (2009)
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 |
|---|---|---|
| Multimodal treatment of patients with FMThe intervention group took part in 2.5-hour sessions of MRT once a week for 10 weeks. This intervention combined physical exercise with stretching. Health education was geared towards pain management, the pathology itself, healthy habits, insomnia, postural correction and ergonomics. The psychological approaches used in the MRT were problem-solving therapy, cognitive behavioural therapy and sophrology. Given the diversity of the sessions, they were directed by a rheumatologist, a nurse, a psychologist, and a physiotherapist. If the patient needed their pharmacological treatment to be altered, they were offered an appointment with the rheumatologist. | Other | Multimodal treatment of patients with FM |
| Association of people with fibromyalgiaThe control group attended the activities organised by the association of people with FMS. These consisted of a weekly 1-hour session of group psychology and a weekly 2-hour session of handicrafts for 10 weeks. | Other | Association of people with fibromyalgia |
Primary outcome
Fibromyalgia impact questionnaire-FIQ
Time frame: At the begining of the enrolment and 10 weeks later
FIQ has been validated for the Spanish population. It is a tool for evaluating the impact of FM on physical capacity and quality of life. FIQ scores range: 0 (best functional capacity and quality of life) to 100 (worst state of health). FIQ scores less than 39 are considered to represent a level of slight deterioration, those between 39 and 59 represent moderate deterioration, and scores greater than 59 imply a severe level of disability. The scale comprises 10 items. The first evaluates functional capacity on an ordinal scale from 0(always) to 3(never). The second and third items are numerical scales that evaluate the number of days that participants have been in a good state of health and the number of days in the week on which they have been able to go to do their normal paid work. The other seven items are rated on analogue scales from 0-10 that measure (i)capacity to do a job, (ii)pain, (iii)fatigue, (iv)morning stiffness, (v)muscular numbness, (vi)anxiety and (vii)depression.
1 secondary outcome
Sociodemographic measures
Time frame: At the begining of the enrolment
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 3 Oct 2022.
- Individual participant dataSharing planned: No
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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.
ANNA LLADSER NAVARRO, NR, MsC principal investigator
Institut Investigacio Sanitaria Pere Virgili
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Pain, run by Institut Investigacio Sanitaria Pere Virgili.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Fibromyalgia impact questionnaire-FIQ (time frame: At the begining of the enrolment and 10 weeks later). 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 3 Oct 2022.