Abstract
Introduction
Non-pharmacological approaches are recommended as first-line
treatment for patients with fibromyalgia. This randomised controlled
trial investigated the effects of a multicomponent rehabilitation
programme for patients with recently diagnosed fibromyalgia in primary
and secondary healthcare.
Methods
Patients with widespread pain ≥3 months were referred to
rheumatologists for diagnostic clarification and assessment of study
eligibility. Inclusion criteria were age 20–50 years, engaged in work or
studies at present or during the past 2 years, and fibromyalgia
diagnosed according to the American College of Rheumatology 2010
criteria. All eligible patients participated in a short patient
education programme before inclusion and randomisation. The
multicomponent programme, a 10-session mindfulness-based and
acceptance-based group programme followed by 12 weeks of physical
activity counselling was evaluated in comparison with treatment as
usual, that is, no treatment or any other treatment of their choice. The
primary outcome was the Patient Global Impression of Change (PGIC).
Secondary outcomes were self-reported pain, fatigue, sleep quality,
psychological distress, physical activity, health-related quality of
life and work ability at 12-month follow-up.
Results
In total, 170 patients were randomised, 1:1, intervention:control.
Overall, the multicomponent rehabilitation programme was not more
effective than treatment as usual; 13% in the intervention group and 8%
in the control group reported clinically relevant improvement in PGIC
(p=0.28). No statistically significant between-group differences were
found in any disease-related secondary outcomes. There were significant
between-group differences in patient’s tendency to be mindful (p=0.016)
and perceived benefits of exercise (p=0.033) in favour of the
intervention group.
Conclusions
A multicomponent rehabilitation programme combining patient
education with a mindfulness-based and acceptance-based group programme
followed by physical activity counselling was not more effective than
patient education and treatment as usual for patients with recently
diagnosed fibromyalgia at 12-month follow-up.
Trial registration number
BMC Registry (NCT96836577).
Funder
The
Norwegian South-Eastern Regional Health
Authority
Cited by
12 articles.
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