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Abstract
Introduction People with fibromyalgia (FM) suffer from symptoms such as widespread pain, non-refreshing sleep, fatigue and reduced quality of life. Effects of pharmacological treatment are questionable and non-pharmacological treatments are recommended as first-line therapy. To date the majority of patients with FM in Norway are not offered any targeted treatment. The aim of this randomised controlled trial is to investigate the effects of a community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling.
Materials and methods General practitioners refer potential participants to a rheumatologist in specialist healthcare for diagnostic clarification and assessment of comorbidities. Inclusion criteria are widespread pain/FM ≥3 months, age 20–50 and work participation (minimum part-time) within the last 2 years. The intervention group attends the VTP comprising 10 weekly 4 hour group sessions plus a booster session after 6 months. Thereafter, they receive 12 weeks of individually tailored physical exercise counselled by physiotherapists at community-based Healthy Life Centers. The control group follows treatment as usual. The primary outcome is Patient Global Impression of Change. Secondary outcomes include self-reported pain, fatigue and sleep quality, psychological distress, mindfulness, health-related quality of life, physical activity, work ability and exercise beliefs and habits. To achieve a power of 80% and allow for 10% dropout, 70 participants are needed in each arm. All analyses will be conducted on intention-to-treat bases and measured as differences between groups at 12 months follow-up.
Ethics and dissemination The study is approved and granted by the Norwegian South-Eastern Regional Health Authority (reference 2016015). Ethics approval was obtained from Regional Committee for Medical and Health Research Ethics (reference 2015/2447/REK sør-øst A). Results will be submitted to appropriate journals and presented in relevant conferences and social media.
Trial registration ISRCTN96836577.
- fibromyalgia
- rehabilitation
- mindfulness-and acceptance based interventions
- physical activity
- health promotion
- primary health care
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Footnotes
Contributors HAZ, KBH and EB conceived the project idea and designed the study. TH, HAZ and SAP are responsible for recruitment. TH and HAZ are responsible for acquisition of data and data management. TH has drafted the manuscript. HAZ has critically revised the manuscript. SAP, KBH and EB have read and approved the final manuscript.
Funding This work was supported by the Norwegian South-Eastern Regional Health Authority (grant number 2016015).
Competing interests None declared.
Patient consent Not required.
Ethics approval The researchers have obtained approval from the Regional Committee for Medical and Health Research Ethics in South East Norway (2015/2447/REK sørøst A). Written consent to participate will be collected before enrolment to the trial.
Provenance and peer review Not commissioned; externally peer reviewed.