The effectiveness of a novel Audio-Visual-Stimulation Device for improving symptoms and quality of life in fibromyalgia; a fully remote large-scale trial

The effectiveness of a novel Audio-Visual-Stimulation Device for improving symptoms and quality of life in fibromyalgia; a fully remote large-scale trial

Background:

Fibromyalgia (FM) is associated with widespread chronic pain as well as additional symptoms including fatigue, sleep disturbances (Clauw, 2014), and mood disturbances (Brito, 2018). The inter-relation of symptoms of pain, poor quality sleep, mood disorders, and fatigue lead to poor quality of life for patients with FM (Jacobs, 2020).

Purpose/Objectives:

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.

Method:

A cohort of 227 participants with FM used the novel AVS device for 28 days.  Outcomes examined were; Fibromyalgia Impact Questionnaire – Revised (FIQ-R), Patient Global Impression of Change (PGIC), General Anxiety Disorder 7 (GAD-7), Patient Health Questionnaire 8 (PHQ-8), Promis 8a Sleep Disturbance Scale (PR8A), Pain-Enjoyment-General-Activity scale (PEG), Pain Catastrophizing Scale (PCS), as well as medication and healthcare usage surveys.

Results:

From Baseline to end of treatment there were improvements in FM symptoms (FIQ-R, p < = 0.001), quality of life (PGIC, p < = 0.001), anxiety (GAD-7, p < = 0.001), depression (PHQ-8, p < = 0.001), sleep (PR8A, p < = 0.001), and pain (PEG, p < = 0.001; PCS, p < = 0.001).  In addition, medication usage decreased by 24% (95%CI, 19-29%) and healthcare visits decreased by 10% (95%CI, 7-15%)

Conclusions: 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 QOL, symptoms, pain, sleep, mood, as well as reducing medication usage and health care visits.

References: Clauw D. J. (2014). Fibromyalgia: a clinical review. JAMA, 311(15), 1547–1555. https://doi.org/10.1001/jama.2014.3266
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
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.