Fibromyalgia
Conditions
Interventions
Sponsors
Universidad Gabriela Mistral
Universidad de las Americas
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women subjects whose age range from 18 to 60 years derived to the rehabilitate foundation with medical diagnosis of fibromyalgia based on the criteria of the American College of Rheumatology; subjects reporting moderate pain of at least 4/10 EVA; subjects who can read, write and follow basic instructions in Spanish; subjects that accept and sign the informed consent.
Exclusion criteria
Exclusion criteria: Women in stages of pregnancy and / or lactation; women with chronic oncological pain; women with metabolic disorder and / or uncontrolled comorbidities and who present some psychiatric or cognitive alteration that prevents them from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected result 1- It is expected to find a decrease in pain intensity assessed through the numeric pain rating scale in the participants of the novel multicomponent treatment group compared to the standard treatment group. ;Result found 1 - At week 12, we found reductions in perceived pain intensity of 1.4 points (standard deviation 2.9) in the new multicomponent treatment and of 0.18 points (standard deviation 0.4) in care standard. Therefore, the difference between groups instead provides an estimate of the effect of the new multicomponent treatment on the Numeric pain rating scale-1.18 points (eta square=0.47, p<0.001). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected result 2- It is expected to find a improve in functional status assessed through the fibromyalgia questionnaire in the participants of the novel multicomponent treatment group compared to the standard treatment group.;Expected result 3 - It is expected to find a improve in catastrophization assessed through the Pain catastrophizing scale in the participants of the novel multicomponent treatment group compared to the standard treatment group.;Expected result 4 - It is expected to find a improve in fear of movement assessed through the Tampa scale in the participants of the novel multicomponent treatment group compared to the standard treatment group. ;Expected result 5- It is expected to find a improve in sleep quality assessed through the Pittsburgh scale in the participants of the novel multicomponent treatment group compared to the standard treatment group. ;Patients allocated to novel multicomponent treatment showed an improvement in Pain catastrophizing (Mean difference= 19.8, Standard deviation=16.9), the between-group difference in change provided an estimate of the effect of the novel multicomponent treatment on Pain catastrophizing scale was -12.5 (Eta square=0.61, p<0.001).;Patients allocated to novel multicomponent treatment showed an improvement in fibromyalgia questionnaire (Mean difference= 21.6, Standard deviation= 25.5), the between-group difference in change provided an estimate of the effect of the novel multicomponent treatment on fibromyalgia questionnaire was -16.21 (eta square=0.58, p<0.001).;Patients allocated to novel multicomponent treatment showed an improvement in Tampa scale (Mean difference=11.1 Standard deviation=10.1). the between-group difference in change provided an estimate of the effect of the novel multicomponent treatment on Tampa scale was -6.15 (Eta square= 0.52, p<0.001).; Patients allocated to novel multicomponent treatment showed an improvement in Pittsburgh (Mean difference=2.1 Standard deviation=6.2), Theref | — |
Countries
Chile
Contacts
Public ContactFelipe Araya Quintanilla
Universidad de las Americas
Outcome results
None listed