This is study designed to confirm the effectiveness of the Sana Device in patients with pain due to fibromyalgia on quality of life as measured by the Fibromyalgia Impact Questionnaire Revised (FIQR). It is a two arm study in which subjects will be randomly assigned to either active device group or sham-controlled group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Audio Visual Stimulation patterns intended to produce a therapeutic benefit.
A control device that mimics the physcial appearance of the Sana device.
Change in Fibromyalgia Symptoms
To confirm the superiority of the active arm over sham on changes in quality of life as measured by the Fibromyalgia Impact Questionnaire Revised (FIQR)
Time frame: 6 weeks
Changes in Generalized Anxiety Symptoms
To confirm the superiority of the active arm over sham on generalized anxiety as measured by Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: 6 weeks
Changes in Depression Symptoms
To confirm the superiority of the active arm over sham on depression sypmtoms as measured by the Patient Health Questionnaire-8 (PHQ-8)
Time frame: 6 weeks
Changes in Sleep Quality
To confirm superiority of the active arm over sham on sleep quality as measured by the PROMIS 4a Sleep Disturbance Scale (PR4A)
Time frame: 6 weeks
Changes in Pain
To confirm the superiority of the active arm over sham on reduction of pain as measured by the Pain Enjoyment General-Activity (PEG) scale
Time frame: 6 weeks
Perceived Change in Quality of Life
To examine the effect of the active arm on perceived change in quality of life as measured by the Patient Global Impression of Change (PGIC) scale
Time frame: 6 weeks
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