The Multidisciplinary Treatment of Fibromyalgia.

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Fibromyalgia; Treatment
• Intervention / Treatment: Other: Association of people with fibromyalgia; Other: Multimodal treatment of patients with FM

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 Type: Observational
• Enrollment (Actual): 46

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Association of people with fibromyalgia; Control group included people affiliated to the FM Patient Association of Terres de l'Ebre, Spain.	Other: Association of people with fibromyalgia; 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.
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.	Other: Multimodal treatment of patients with FM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the begining of the enrolment and 10 weeks later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the begining of the enrolment

Collaborators and Investigators

• Sponsor: Institut Investigacio Sanitaria Pere Virgili
• Investigators: Principal Investigator: ANNA LLADSER NAVARRO, NR, MsC, Institut Investigacio Sanitaria Pere Virgili

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2016
• Primary Completion (ACTUAL): August 31, 2016
• Study Completion (ACTUAL): June 15, 2017

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (ACTUAL): September 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pain; quality of life; fibromyalgia; multidomal treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: CEIC-1488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No