1237: Six Month Clinical Outcomes of a Digital Therapeutic Augmented Virtual Care Clinic for Fibromyalgia Management

Background/Purpose: Guidelines for fibromyalgia treatment recommend non-pharmacologic treatment, including cognitive behavioral therapy, alongside medications [1-3]. However, patient access to multi-modal treatment is frequently limited due to a lack of clinics offering integrated care. Early results from a virtual specialty clinic (Swing Care), augmented by an FDA-cleared digital behavioral therapy (Stanza™), have demonstrated significant improvements at 90 days [4]. The purpose of this analysis is to evaluate six-month outcomes of a digital therapeutic augmented virtual specialty clinic for FM.

Methods: A chart review was conducted with IRB approval and consent waiver (Allendale IRB, Old Lyme, CT). FM patients assessed using the 2016 diagnostic criteria received multimodal treatment, combining non-opioid drug and non-drug therapies, including the option of the digital behavioral therapy. Endpoints collected included Patient Global Impression of Change (PGIC), Fibromyalgia Impact Questionnaire-Revised (FIQ-R), Pain Intensity, and Pain Interference (0-10 Likert Scales). Data were collected at baseline, 2, 4, and 6 months. All patients with at least six-month follow-up data were included in analysis.

Results: Outcomes data were available for 233 patients (Table 1). Baseline FIQ-R total score was 63.6 ± 1.2 [mean ± SE] while baseline pain intensity and pain interference scores were 6.9 ± 0.1 and 7.3 ± 0.1 [mean ± SE], respectively (Table 1). At 2 months, 75.5% of patients reported improvement, with 35.4% much improved or better. At 6 months, 88.0% of patients reported improvement, with 55.4% much improved or better (Figure 1). Average FIQ-R total score was significantly reduced at 6 months (by 14.9 ± 1.1 [mean ± SE] points, p< 0.0001), with significant improvements starting at 2 months (Figure 2). Significant improvements were also observed in FIQ-R Function, Impact, and Symptom domains (p< 0.0001). By six months, pain intensity and pain interference scores were significantly reduced by 1.5 ± 0.1 and 2.0 ± 0.2 [mean ± SE] points, respectively, p values < 0.0001.

Conclusion: Sustained improvements in well-being and reductions in FM severity, pain intensity, and pain interference were demonstrated at the virtual care clinic. These findings highlight the effectiveness of the multidisciplinary approach and the potential of the virtual care clinic as a patient-centered and accessible solution for managing FM.

References

[1] Buckhardt CS et al. Guideline for the management of fibromyalgia syndrome pain in adults and children. Glenview Am Pain Soc (APS); (Clinical Pract Guidel no 4). 2005;4:109.

[2] Winslow BT, et al. Fibromyalgia: diagnosis and management. Am Fam Physician. 2023;107(2):137-144.

[3] Fitzcharles MA, et al. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013;18(3):119-126.

[4] Shumay D, et al. Society of Behavioral Medicine (SBM) 2024 Annual Meeting.