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A Randomized, Sham-Controlled Trial of Cranial Electrical Stimulation for Fibromyalgia Pain and Physical Function, Using Brain Imaging Biomarkers
Published on: January 5, 2024
A randomized controlled trial of a wellness intervention for women with fibromyalgia syndrome
Alexa K Stuifbergen1, Shelley A Blozis, Heather Becker
1School of Nursing, The University of Texas at Austin, Austin, TX 78701, USA. astuifbergen@mail.utexas.edu
Objective:
To examine the effects of a wellness intervention, Lifestyle Counts, for women with fibromyalgia syndrome on the level of self-efficacy for health-promoting behaviours, health-promoting activity and perceived quality of life.
Design:
A randomized controlled single-blinded trial with treatment and attention-control groups.
Setting:
Community in the southwestern United States.
Subjects:
Convenience sample of 187 women (98 treatment, 89 attention control) with fibromyalgia syndrome (mean age = 53.08 years, SD 9.86).
Intervention:
The two-phase Lifestyle Counts intervention programme included lifestyle change classes for eight weeks, with goal-setting and telephone follow-up for three months. Participants in the attention-control group were offered an equivalent amount of contact in classes on general disease-related information and health education topics and unstructured follow-up phone calls. Participants were followed for a total of eight months after baseline.
Outcome Measures:
Self-report instruments measuring self-efficacy for health behaviours, health-promotion behaviours and health-related quality of life (SF-36 and the Fibromyalgia Impact Questionnaire) were completed at baseline, two months (after the classes), five months (after telephone follow-up) and at eight months.
Results:
Both groups improved significantly (P<0.05) over time on the measures of self-efficacy, health behaviours, fibromyalgia impact and quality of life. There were significant group x time interactions for scores on the Health Promoting Lifestyle II subscales of physical activity and stress management.
Conclusions:
The Lifestyle Counts wellness intervention holds promise for improving health-promoting behaviours and quality of life of women with fibromyalgia syndrome.