Jeffrey Bower, Ph.D.
VP Analytics
Sana Health
Boulder, Colorado
Martin Cheatle, Ph.D.
Associate Professor
Department of Psychiatry - Perelman School of Medicine, University of Pennsylvania
Perelman School of Medicine, University of Pennsylvania
Philadelphia, Pennsylvania
Crystal George, MS
VP Clinical Affairs
Sana Health
Louisville, Colorado
Richard Hanbury, MBA
CEO
Sana Health
Louisville, Colorado
In this open label fully-remote study we assessed the effectiveness a novel Audio Visual Stimulation (AVS) improving Quality of Life (QOL) and symptoms of FM in a real-world setting. Fibromyalgia (FM) is associated with widespread chronic pain as well as additional symptoms including fatigue, sleep disturbances1, and mood disturbances2. The inter-relation of symptoms of pain, poor quality sleep, mood disorders, and fatigue lead to poor quality of life for patients with Fibromyalgia3.
Methods:
500 (projected) subjects with FM used the novel AVS device for 28 days. Outcome examined were; Fibromyalgia Impact Questionnaire – Revised (FIQ-R), Patient Global Impression of Change Quality of Life (PGIC-QOL), General Anxiety Disorder 7 (GAD-7), Patient Health Questionnaire 8 (PHQ-8), Pain Catastrophizing Scale (PCS), Promis 8a (PR8A), and the Pain Enjoyment General Activity scale (PEG).
Results:
From Baseline to end of treatment there were improvements FM symptom severity (FIQ-R, p < 0.001), quality of life (PGIC-QOL, p < 0.001), anxiety (GAD-7, p < 0.001), depression (PHQ-8, p < 0.001), pain catastrophizing (PSC, p = 0.013), sleep (PR8A, p < 0.001), and pain (PEG, p < 0.001).
Conclusion:
FM is a common pain disorder that leads to significant suffering. This pilot study demonstrates the effectiveness of a novel, safe AVS device in improving FM symptoms, QOL, pain, sleep, depression, and anxiety.
References: 1. Clauw D. J. (2014). Fibromyalgia: a clinical review. JAMA, 311(15), 1547–1555. https://doi.org/10.1001/jama.2014.3266
2. Brito, R., Santos, P., Oliveira, Pina, L., Antoniolli, A., Almeida, J., Picot, L. Zengin, G. & Quintans, J., Quintans-Júnior, L. (2018). Natural Products as Promising Pharmacological Tools for the Management of Fibromyalgia Symptoms – A Review. (pp. 57-78). Intech. http://dx.doi.org/10.5772/intechopen.70016
3. Jacobs, H., Bockaert, M., Bonte, J., D'Haese, M., Degrande, J., Descamps, L., ... & De Bacquer, D. (2020). The impact of a group-based multidisciplinary rehabilitation program on the quality of life in patients with fibromyalgia: results from the QUALIFIBRO Study. JCR: Journal of Clinical Rheumatology, 26(8), 313-319.