Abstract

BackgroundPatients with fibromyalgia (FM) suffer from high symptom burden and few available treatments. EULAR evidence-based recommendations for the management of FM state that optimal management should focus on prompt diagnosis, patient education and non-pharmacological treatments1. A recent systematic review of mindfulness- and acceptance-based interventions for patients with FM showed small to moderate beneficial health effects2. We tested a 10-session group-based mindfulness- and acceptance-based intervention, the Vitality Training Programme3, followed by low threshold physical exercise counselling in primary health care, compared to treatment as usual (TAU) for patients diagnosed with FM.ObjectivesTo explore possible changes in health status in a group of FM patients two years after participation in a multicomponent rehabilitation programme.MethodsA total of 170 patients with confirmed FM diagnosis according to ACR 2011-criteria were randomised, 85 to intervention and 85 to control. Self-reported data were collected electronically at baseline, 3 and 12 months. There were no statistically significant health effects in any disease-related variables at 12 months. However, there were significant between-group differences in patients’ tendency to be mindful4. All patients were asked to complete the same questionnaires two years after completion of the intervention group. Because the TAU-group had been offered the same programme after 12 months, only data from the intervention group was included in this study. Primary outcome was Patient Global Impression of Change (PGIC), scored as 1= much worse, through 4=no change, to 7=much better. Values 6 and 7 were considered clinically relevant improvement. Secondary outcomes were self-reported pain, fatigue, sleep quality, psychological distress, mindfulness, physical activity, motivation and barriers for physical activity, and work participation. Mean changes from baseline to two years were analysed by paired sample t-tests.ResultsTotally, 48 (56.5%) of the patients who had been randomised to the intervention group responded to the questionnaires, 94% female, median (range) age 47 (28 to 54), symptoms duration 12 (5 to 33) years. Only seven patients reported clinically relevant improvement on PGIC; 32 (67%) reported little better, worse or no change (Figure 1). There were small improvements in pain (p=0.048), fatigue (p=0.014) and self-efficacy for physical activity (p=0.012), but the changes were probably not clinically relevant. The improvement seen in patients’ tendency to be mindful at 12 months was sustained (p=0.012). Only 58% were in paid work compared to 70% at baseline.Figure 1.ConclusionTwo years after participation in a multicomponent rehabilitation programme comprising mindfulness and acceptance training and physical activity counselling, FM patients still reported high symptom burden and no improvement in their health status. The increased tendency to be mindful was not reflected in improvements in disease-related outcomes. It was not possible to compare groups (intervention and TAU), because the TAU-group had been offered the intervention before the two-years data collection. However, there was no worsening of symptoms, which might have been the case without any intervention.

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