Effectiveness and preliminary cost analysis of the FIBROWALK multicomponent therapy

Background & Aims

Fibromyalgia (FM), affecting 2.7% globally (Queiroz, 2013), mainly targets women aged 40-50, causing chronic musculoskeletal pain, fatigue, and sleep issues, often accompanied by anxiety (13%–63.8%) and depressive disorders (20%–80%) (Häuser et al., 2015). FM leads to the highest rates of unemployment, sick leave, disability claims, and absenteeism, with 23%–66% leaving work due to its impact (Leadley et al., 2012).
Empirical evidence suggests that multicomponent approaches, combining therapeutic physical exercise with psychological and educational interventions, are effective for individuals with FM (Thieme et al., 2017). The On&Out study is aimed at assessing the FIBROWALK multicomponent intervention’s effectiveness in online (FIBRO-On) and outdoors (FIBRO-Out) compared to Treatment-As-Usual (TAU) for FM individuals. Additionally, the study examined the effects of the interventions on direct (health-related) and indirect (absenteeism from work) costs as a secondary variable.

Methods

This randomized controlled trial (RCT) included 225 participants with an FM diagnosis (ACR 2010/2011 criteria) recruited at the Central Sensitivity Syndromes Specialized Unit at Vall d’Hebron Barcelona Hospital. Participants were randomly assigned to TAU alone (n=75), TAU + FIBRO-On (n=75), or TAU + FIBRO-Out (n=75). The FIBROWALK is a 12-week comprising CBT, mindfulness training, therapeutic physical exercise, and Pain Neuroscience Education which can be delivered in face-to-face and online formats (Serrat et al., 2020; Serrat et al., 2021a; Serrat et al., 2021b; Serrat et al., 2022b). Participants were assessed at baseline, post-intervention, and 6-month follow-up (i.e. functional impairment, pain, anxiety and depression symptoms, and kinesiophobia). Direct and indirect costs at baseline and 6-month follow-up (6-month time horizon) were also included as secondary outcomes. ANCOVA analyses were conducted to evaluate treatment effects.

Results

The results indicate that both FIBRO-On and FIBRO-Out interventions exhibit comparable effectiveness in comparison to TAU. Both interventions were particularly effective in the short term. Notably, the FIBRO-Out intervention, when compared to TAU, demonstrated superior post-intervention outcomes in terms of improving functionality, pain, anxiety, depression, and kinesiophobia. Although these effects diminished at follow-up, kinesiophobia displayed a sustained improvement. The FIBRO-On intervention showed superiority over TAU post-intervention in improving functionality, pain, anxiety, depression, and kinesiophobia, with most effects persisting at follow-up, except for anxiety scores. There were no observed effects on cost savings when comparing FIBRO-Out or FIBRO-On to TAU. Comparing FIBRO-Out and FIBRO-On, no differences were found except for a slight superiority of FIBRO-Out in depression scores at the follow-up.

Conclusions

The On&Out study findings suggest that both FIBRO-On and FIBRO-Out interventions exhibit comparable and superior effectiveness to TAU for individuals with FM, particularly in the short term. Simultaneously, preliminary cost analyses suggest that while both interventions demonstrate effectiveness, they may not yield cost savings compared to TAU. A comprehensive health economic analysis is thus warranted to provide a thorough understanding of the economic implications associated with these interventions.

References

Leadley R. M., Armstrong N., Lee Y. C., Allen A., Kleijnen J. (2012). Chronic diseases in the European union: The prevalence and health cost implications of chronic pain. J. Pain Palliat. Care Pharmacother. 26, 310–325. doi:10.3109/15360288.2012.736933
Häuser W., Ablin J., Fitzcharles M. A., Littlejohn G., Luciano J. V., Usui C., et al. (2015). Fibromyalgia. Nat. Rev. Dis. Prim. 1, 15022. doi:10.1038/nrdp.2015.22
Queiroz L. P. (2013). Worldwide epidemiology of fibromyalgia. Curr. Pain Headache Rep. 17, 356. doi:10.1007/s11916-013-0356-5
Serrat M., Albajes K., Navarrete J., Almirall M., Lluch Girbé E., Neblett R., et al. (2022b). Effectiveness of two video-based multicomponent treatments for fibromyalgia: The added value of cognitive restructuring and mindfulness in a three-arm randomised controlled trial. Behav. Res. Ther. 158, 104188. doi:10.1016/j.brat.2022.104188
Serrat M., Almirall M., Musté M., Sanabria-Mazo J. P., Feliu-Soler A., Méndez-Ulrich J. L., et al. (2020). Effectiveness of a multicomponent treatment for fibromyalgia based on pain neuroscience education, exercise therapy, psychological support, and nature exposure (NAT-FM): A pragmatic randomized controlled trial. J. Clin. Med. 9, 3348. doi:10.3390/jcm9103348
Serrat M., Coll-Omaña M., Albajes K., Solé S., Almirall M., Luciano J. V., et al. (2021a). Efficacy of the FIBROWALK multicomponent program moved to a virtual setting for patients with fibromyalgia during the COVID-19 pandemic: A proof-of-concept RCT performed alongside the state of alarm in Spain. Int. J. Environ. Res. Public Health 18, 10300. doi:10.3390/ijerph181910300
Serrat M. (2022a). Integrating pain neuroscience education in multicomponent approaches for people with fibromyalgia: A practical guide for clinicians. Unpublished.
Serrat M., Sanabria-Mazo J. P., Almirall M., Musté M., Feliu-Soler A., Méndez-Ulrich J. L., et al. (2021b). Effectiveness of a multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness in patients with fibromyalgia (FIBROWALK study): A randomized controlled trial. Phys. Ther. 101, pzab200. pzab 200. doi:10.1093/ptj/pzab200