Women with fibromyalgia.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 30-55 years; fulfillment of the American College of Rheumatology 1990 or 2010 criteria for diagnosis of FM [3]; residence in the metropolitan area of Recife, PE; stable psychological, physical, and drug therapy in the preceding month.
Exclusion criteria
Exclusion criteria: Patients attending physiotherapy sessions, using gait assistance devices, suffering from associated autoimmune rheumatic diseases, or presenting uncontrolled comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Expected outcome (1): impact of fibromyalgia on patients' quality of life measured by the FIQ (Fibromyalgia Impact Questionnaire, ranging from 0 to 100) at the end of the study (after 10 weeks). The mean of the final FIQ of the intervention and control groups will be statistically compared, with an expected difference of 15 points between groups for the purpose of calculating the sample size. ;Main outcome observed (1): There was a statistically significant difference between groups in the mean FIQ scores at the end of the study.;Expected outcome (2): pain level measured by visual analogue scale (VAS, ranging from 0 to 10) at the end of the study. Averages of VAS in the experimental groups will be compared statistically.;Observed outcome (2): mean pain level measured by VAS was not statistically different between the groups at the end of the study.;Expected outcome (3): Flexibility (in centimeters) as measured by the sit and reach test (SRT) at the end of the study. The TSA means in the experimental groups will be compared statistically.;Observed outcome (3): Mean values of SRT in the experimental and control groups were statistically different at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcomes (1): Individual values from each of the 10 FIQ (Fibromyalgia Impact Questionnaire) items at the end of the study (after 10 weeks). The mean values of the scores of each item will be compared between the experimental and control groups at the end of the study.;Observed outcome (1): Mean values of 8 of the 10 scores were statistically different between the groups at the end of the study.;Expected outcome (2): count of the number of analgesic tablets ingested by each patient over the 10-week study period. The mean number of ingested tablets will be compared statistically at the end of the study.;Observed outcome (2): There was a statistically significant difference between groups in the mean number of tablets ingested by each patient during the study.;Expected outcome (3): Counting the number of pain areas (delimited by the body pain map) of each patient at the end of the study. The mean number of patients' pain areas will be compared between groups at the end of the study.;Observed outcome (3): There was no statistically significant difference in the mean number of painful areas per patient at the end of the study between the groups. | — |
Countries
Brazil
Contacts
Faculdade Pernambucana de Saúde;Faculdade Pernambucana de Saúde