The Multidisciplinary Treatment of Fibromyalgia.

NCT ID: NCT03673553

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-06-15

Brief 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. 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.

Conditions

Fibromyalgia; Pain; Treatment; Quality of Life

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Association of people with fibromyalgia

Control group included people affiliated to the FM Patient Association of Terres de l'Ebre, Spain.

Association of people with fibromyalgia

Intervention Type: OTHER

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.

Multimodal treatment of patients with FM

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role: lead

Responsible Party

Verge Cinta_Carlos Lopez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ANNA LLADSER NAVARRO, NR, MsC

Role: PRINCIPAL_INVESTIGATOR

Institut Investigacio Sanitaria Pere Virgili

Other Identifiers

CEIC-1488

Identifier Type: -

Identifier Source: org_study_id