Remote Participation (Within USA) Trial of Sana Pain Reliever

This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full scale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full subscale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP).This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full subscale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full subscale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full subscale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Subscale from 0-100. Full scale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

The Questionnaire Type 9 for Depression (PHQ-9) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care and is used to monitor the severity of depression and response to treatment. Full scale from 0-27, with higher score indicating more severe symptoms. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Full score from 0-21, with higher score indicating worse sleep quality. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

The Beck Depression Inventory (BDI) is used to evaluate depression symptoms, which are estimated to be highly prevalent in chronic pain populations. This questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Depression may be a major contributor to a lack of reduction of pain. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

The WHOQOL-pain scale is for a specific focus on the impact of pain on QOL. The WHOQOL-pain has 22 items on the pain and discomfort module (PDM) and the importance of items within a user's daily life. The Pain facet has 4 items (1-5) which are averaged to produce the WHOQOL-Pain Pain Facet. Full scale from 1-5 with higher score indicating higher quality of life. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

The WHOQOL-BREF is a used to produce a quality of life profile for an individual that is derived from four domains. There are 26 questions which ask users to respond to quality of life (QOL) questions on a scale of 1-5 (1-Not at All, Very Poor, or Very Dissatisfied; 5- Completely, Very Good, or Very Satisfied). The QOL domain assess quality of life and has a score from 1-100. Full scale from 0-100 with higher score indicating higher quality of life. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

The Patient's Global Impression of Change (PGIC) will be used to assess self-reported relieving effect. It will evaluate pain from no change (score 0-1), minimally improved (score 2-3), much improved (score 4-5), and very much improved (score 6-7). The patients will answer the following question: "Since beginning treatment at this program, how would you describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life related to your condition?". Full score from 0-7, with higher score indicating more improvement. Change in score at Week 14 as compared to Week 10.

Visual Analog Scale (VAS) to measure pain: a measure of "no pain" to "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Full scale from 0-100 with higher score indicating more pain.

Visual Analog Scale (VAS) to measure sleep: a measure of "did not sleep at all" to "best possible night's sleep" along a line. Participants will be asked to mark the level of their sleep along the line. The Sana Health application will prompt users to answer this scale before they use the device for the first time each day. A linear mixed model used the daily sleep-vas scores to estimate the percent of change for both arms over the course of the study (Baseline to Week-14). Percent change from mean of first 3 days. 1% to 100% with higher score indicating improved sleep quality.