Chronic Pain, Neuropathic Pain, Pain
Conditions
Keywords
Neuropathic pain, Pain, Wearable devices, Pain management, Neuromodulation
Brief summary
Randomized controlled trial to assess the effectiveness and patient perception of the benefit of the Sana Pain Reliever in individuals with chronic neuropathic pain.The study is fully remote with four study visits taking place over teleconferencing and the study devices mailed to the participants to use at home for 8-14 weeks.
Detailed description
Chronic neuropathic pain (NP) is an extremely debilitating condition with few treatment options and many of which with multiple side effects. This will be a randomized, sham-controlled trial that will investigate the effectiveness of a novel wearable device called the Sana Pain Reliever (Sana PR) at reducing chronic neuropathic pain. The Sana PR is a device comprised of a Mask to be worn over the eyes with a pair of ear buds to be worn in ears. It displays light and sounds in a predetermined algorithm which runs for 16 minutes at a time. The underlying mechanism of action for the Sana PR is Audio Visual Stimulation (AVS), a form of non-pharmacological intervention that induces a brain wave response called Frequency Following Response (FFR), which has been used for both performance enhancement and symptom management. The device will be used with a compatible tablet application that will collect data from each session that the device is used. This data will be collected through user inputs of responses to several questionnaires. This will be an at-home trial and participants will be loaned the Sana Pain Reliever device and a tablet device to run the application for the duration of the study. The trial will last a total of 14 weeks and will involve four study visits, either in-person at the Abilities Research Center at Mount Sinai Hospital in New York City, or remotely using a video call. The trial includes two baseline sessions on weeks 0 and 2, 8 weeks of the at-home intervention, and post-intervention sessions at the end of weeks 10 and 14. Participants will be instructed to use the device at the end of the day prior to going to sleep as well as whenever they experience greater than typical pain during the day . Data during the at home portion of the trial will be recorded daily via the application. The application will also prompt participants to answer fortnightly weekly questionnaires and send out compliance reminders. Additionally, a series of pain, sleep and quality of life assessments will be completed by participants at both baseline visits, a post-intervention visit and a 4-week follow-up visit.
Interventions
DEVICESana Pain Reliever
Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 16 minutes and run under the device's normal settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day.
DEVICESham SPR
Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 16 minutes and run under the device's sham settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day.
Sponsors
Sana Health, Inc.
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Double blind, randomized, sham-controlled trial parallel arm study that will assess the effectiveness and patient perception of the benefit of the Sana Pain Reliever in individuals with chronic neuropathic pain.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed clinical diagnosis of neuropathic pain * Age of 18 years or older at time of consent * Fluent in English * Consistent medications for the last 4 weeks prior to the first baseline visit (week 0)
Exclusion criteria
* Diagnosis of photosensitive epilepsy * Active ear or eye infection * Vision impairments that affect perception of light in one or both eyes * Deafness in one or both ears * Severe depression (Score higher than 30 points on the Beck's Depression Inventory)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuropathic Pain Symptom Inventory (NPSI) | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient's Global Impression of Change (PGIC) | Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Visual Analogue Scale (VAS)-Sleep | first 3 days and 14 weeks | 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. |
| Visual Analogue Scale (VAS)-Pain | before and after each time device used up to 14 weeks | 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. |
| Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in Beck Depression Inventory (BDI) | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
| Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 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. |
Countries
United States
Participant flow
Recruitment details
104 participants consented, with 75 enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Real SPR Participants will receive the device which will run the real Sana Pain Reliever (SPR) protocol and a tablet with a mobile application to record pain levels and other questionnaires
Sana Pain Reliever: Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 16 minutes and run under the device's normal settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day. | 34 |
| Sham SPR Participants will receive the device which will run a sham SPR protocol and a tablet with a mobile application to record pain levels and other questionnaires
Sham SPR: Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 16 minutes and run under the device's sham settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day. | 41 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Study | Adverse Event | 2 | 0 |
| Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Sham SPR | Total | Real SPR |
|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 15.2 | 45.4 years STANDARD_DEVIATION 14.4 | 42 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 58 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) White | 25 Participants | 48 Participants | 23 Participants |
| Sex: Female, Male Female | 25 Participants | 52 Participants | 27 Participants |
| Sex: Female, Male Male | 16 Participants | 23 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 41 |
| other Total, other adverse events | 4 / 34 | 1 / 41 |
| serious Total, serious adverse events | 0 / 34 | 0 / 41 |
Outcome results
Primary
Change in Neuropathic Pain Symptom Inventory (NPSI)
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) | baseline 1 (Week 0) | 47.6 score on a scale | Standard Deviation 17.2 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) | Baseline 2 (Week 2) | 48.7 score on a scale | Standard Deviation 17.6 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) | Post-assessment (Week 10) | 39.6 score on a scale | Standard Deviation 21.9 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) | Follow up (Week 14) | 36.6 score on a scale | Standard Deviation 21 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) | Follow up (Week 14) | 39.1 score on a scale | Standard Deviation 23.1 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) | baseline 1 (Week 0) | 41 score on a scale | Standard Deviation 20.5 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) | Post-assessment (Week 10) | 34 score on a scale | Standard Deviation 20.3 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) | Baseline 2 (Week 2) | 41.5 score on a scale | Standard Deviation 23.5 |
Primary
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | baseline 1 (Week 0) | 59.1 score on a scale | Standard Deviation 25.3 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | Baseline 2 (Week 2) | 58.7 score on a scale | Standard Deviation 27.5 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | Post-assessment (Week 10) | 41.5 score on a scale | Standard Deviation 28.2 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | Follow up (Week 14) | 32.9 score on a scale | Standard Deviation 27.9 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | Follow up (Week 14) | 44 score on a scale | Standard Deviation 30 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | baseline 1 (Week 0) | 43.8 score on a scale | Standard Deviation 31.8 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | Post-assessment (Week 10) | 34.4 score on a scale | Standard Deviation 31.4 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | Baseline 2 (Week 2) | 44.7 score on a scale | Standard Deviation 30.6 |
Primary
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | baseline 1 (Week 0) | 43.5 score on a scale | Standard Deviation 27.4 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | Baseline 2 (Week 2) | 47.1 score on a scale | Standard Deviation 23.1 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | Post-assessment (Week 10) | 38.8 score on a scale | Standard Deviation 28.5 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | Follow up (Week 14) | 31.9 score on a scale | Standard Deviation 30 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | Follow up (Week 14) | 35.0 score on a scale | Standard Deviation 24.7 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | baseline 1 (Week 0) | 36.6 score on a scale | Standard Deviation 26.6 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | Post-assessment (Week 10) | 31.0 score on a scale | Standard Deviation 27.8 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | Baseline 2 (Week 2) | 34.9 score on a scale | Standard Deviation 27.3 |
Primary
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | baseline 1 (Week 0) | 53.6 score on a scale | Standard Deviation 26.9 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | Baseline 2 (Week 2) | 52.9 score on a scale | Standard Deviation 26.4 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | Post-assessment (Week 10) | 42.5 score on a scale | Standard Deviation 31 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | Follow up (Week 14) | 43.8 score on a scale | Standard Deviation 28.1 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | Follow up (Week 14) | 41.4 score on a scale | Standard Deviation 31.9 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | baseline 1 (Week 0) | 42.2 score on a scale | Standard Deviation 31.3 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | Post-assessment (Week 10) | 30.7 score on a scale | Standard Deviation 30.5 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | Baseline 2 (Week 2) | 42.5 score on a scale | Standard Deviation 30.8 |
Primary
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | baseline 1 (Week 0) | 36.4 score on a scale | Standard Deviation 24.6 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | Baseline 2 (Week 2) | 39.5 score on a scale | Standard Deviation 29.5 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | Post-assessment (Week 10) | 33.5 score on a scale | Standard Deviation 27.8 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | Follow up (Week 14) | 29.7 score on a scale | Standard Deviation 28.2 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | Follow up (Week 14) | 32.8 score on a scale | Standard Deviation 28.9 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | baseline 1 (Week 0) | 35.2 score on a scale | Standard Deviation 26.1 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | Post-assessment (Week 10) | 30.3 score on a scale | Standard Deviation 25.2 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | Baseline 2 (Week 2) | 39.4 score on a scale | Standard Deviation 28.7 |
Primary
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | baseline 1 (Week 0) | 56.8 score on a scale | Standard Deviation 26.7 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | Baseline 2 (Week 2) | 54.8 score on a scale | Standard Deviation 26.5 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | Post-assessment (Week 10) | 45.6 score on a scale | Standard Deviation 28.8 |
| Real SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | Follow up (Week 14) | 46.3 score on a scale | Standard Deviation 30 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | Follow up (Week 14) | 48.2 score on a scale | Standard Deviation 30.1 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | baseline 1 (Week 0) | 51.2 score on a scale | Standard Deviation 30.8 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | Post-assessment (Week 10) | 45.6 score on a scale | Standard Deviation 28.8 |
| Sham SPR | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | Baseline 2 (Week 2) | 48.8 score on a scale | Standard Deviation 32.1 |
Secondary
Change in Beck Depression Inventory (BDI)
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Beck Depression Inventory (BDI) | baseline 1 (Week 0) | 8.6 score on a scale | Standard Deviation 6 |
| Real SPR | Change in Beck Depression Inventory (BDI) | baseline 2 (Week 2) | 10.0 score on a scale | Standard Deviation 7.3 |
| Real SPR | Change in Beck Depression Inventory (BDI) | Post-assessment (Week 10) | 8.8 score on a scale | Standard Deviation 7.7 |
| Real SPR | Change in Beck Depression Inventory (BDI) | Follow Up (Week 14) | 8.6 score on a scale | Standard Deviation 7 |
| Sham SPR | Change in Beck Depression Inventory (BDI) | Follow Up (Week 14) | 9.0 score on a scale | Standard Deviation 7.2 |
| Sham SPR | Change in Beck Depression Inventory (BDI) | baseline 1 (Week 0) | 8.0 score on a scale | Standard Deviation 5.4 |
| Sham SPR | Change in Beck Depression Inventory (BDI) | Post-assessment (Week 10) | 8.3 score on a scale | Standard Deviation 6.4 |
| Sham SPR | Change in Beck Depression Inventory (BDI) | baseline 2 (Week 2) | 10.0 score on a scale | Standard Deviation 7.3 |
Secondary
Change in General Anxiety Disorder 7-item Questionnaire (GAD-7)
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | baseline 1 (Week 0) | 6.4 score on a scale | Standard Deviation 4.2 |
| Real SPR | Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | baseline 2 (Week 2) | 6.3 score on a scale | Standard Deviation 3.3 |
| Real SPR | Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | Post-assessment (Week 10) | 6.0 score on a scale | Standard Deviation 5.2 |
| Real SPR | Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | Follow up (Week 14) | 5.8 score on a scale | Standard Deviation 4.3 |
| Sham SPR | Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | Follow up (Week 14) | 4.0 score on a scale | Standard Deviation 3.6 |
| Sham SPR | Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | baseline 1 (Week 0) | 5.0 score on a scale | Standard Deviation 3.8 |
| Sham SPR | Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | Post-assessment (Week 10) | 3.9 score on a scale | Standard Deviation 3.4 |
| Sham SPR | Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | baseline 2 (Week 2) | 5.7 score on a scale | Standard Deviation 4.5 |
Secondary
Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9)
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | baseline 1 (Week 0) | 5.8 score on a scale | Standard Deviation 3.2 |
| Real SPR | Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | baseline 2 (Week 2) | 7.4 score on a scale | Standard Deviation 3.9 |
| Real SPR | Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | Post-assessment (Week 10) | 5.9 score on a scale | Standard Deviation 6.1 |
| Real SPR | Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | Follow Up (Week 14) | 6.4 score on a scale | Standard Deviation 5.2 |
| Sham SPR | Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | Follow Up (Week 14) | 6.0 score on a scale | Standard Deviation 5.1 |
| Sham SPR | Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | baseline 1 (Week 0) | 5.6 score on a scale | Standard Deviation 4.5 |
| Sham SPR | Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | Post-assessment (Week 10) | 5.5 score on a scale | Standard Deviation 4.6 |
| Sham SPR | Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | baseline 2 (Week 2) | 6.1 score on a scale | Standard Deviation 4.5 |
Secondary
Change in Patient's Global Impression of Change (PGIC)
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.
Time frame: Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Patient's Global Impression of Change (PGIC) | Post-assessment (Week 10) | 2.8 score on a scale | Standard Deviation 1.9 |
| Real SPR | Change in Patient's Global Impression of Change (PGIC) | Follow up (Week 14) | 2.7 score on a scale | Standard Deviation 1.9 |
| Sham SPR | Change in Patient's Global Impression of Change (PGIC) | Post-assessment (Week 10) | 2.9 score on a scale | Standard Deviation 1.9 |
| Sham SPR | Change in Patient's Global Impression of Change (PGIC) | Follow up (Week 14) | 2.5 score on a scale | Standard Deviation 2.1 |
Secondary
Change in Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in Pittsburgh Sleep Quality Index (PSQI) | baseline 2 (Week 2) | 9.0 score on a scale | Standard Deviation 3.7 |
| Real SPR | Change in Pittsburgh Sleep Quality Index (PSQI) | Follow up (Week 14) | 8.7 score on a scale | Standard Deviation 4.4 |
| Real SPR | Change in Pittsburgh Sleep Quality Index (PSQI) | Post-assessment (Week 10) | 7.4 score on a scale | Standard Deviation 4.7 |
| Real SPR | Change in Pittsburgh Sleep Quality Index (PSQI) | baseline 1 (Week 0) | 9.1 score on a scale | Standard Deviation 3.8 |
| Sham SPR | Change in Pittsburgh Sleep Quality Index (PSQI) | Post-assessment (Week 10) | 8.0 score on a scale | Standard Deviation 5 |
| Sham SPR | Change in Pittsburgh Sleep Quality Index (PSQI) | baseline 2 (Week 2) | 10.1 score on a scale | Standard Deviation 4.3 |
| Sham SPR | Change in Pittsburgh Sleep Quality Index (PSQI) | baseline 1 (Week 0) | 10.3 score on a scale | Standard Deviation 3.8 |
| Sham SPR | Change in Pittsburgh Sleep Quality Index (PSQI) | Follow up (Week 14) | 9.2 score on a scale | Standard Deviation 4.1 |
Secondary
Change in World Health Organization Quality of Life Bref (WHOQOL-BREF)
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | baseline 1 (Week 0) | 50.4 score on a scale | Standard Deviation 21 |
| Real SPR | Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | baseline 2 (Week 2) | 51.8 score on a scale | Standard Deviation 23.2 |
| Real SPR | Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | Post-assessment (Week 10) | 57.7 score on a scale | Standard Deviation 24.2 |
| Real SPR | Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | Follow up (Week 14) | 50.5 score on a scale | Standard Deviation 21.3 |
| Sham SPR | Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | Follow up (Week 14) | 52.1 score on a scale | Standard Deviation 22.4 |
| Sham SPR | Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | baseline 1 (Week 0) | 54.6 score on a scale | Standard Deviation 21.8 |
| Sham SPR | Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | Post-assessment (Week 10) | 59.0 score on a scale | Standard Deviation 22.7 |
| Sham SPR | Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | baseline 2 (Week 2) | 50.9 score on a scale | Standard Deviation 22.6 |
Secondary
Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet
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.
Time frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | baseline 1 (Week 0) | 2.6 score on a scale | Standard Deviation 0.5 |
| Real SPR | Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | baseline 2 (Week 2) | 2.7 score on a scale | Standard Deviation 0.5 |
| Real SPR | Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | Post-assessment (Week 10) | 2.9 score on a scale | Standard Deviation 0.7 |
| Real SPR | Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | Follow up (Week 14) | 2.9 score on a scale | Standard Deviation 0.8 |
| Sham SPR | Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | Follow up (Week 14) | 3.0 score on a scale | Standard Deviation 0.7 |
| Sham SPR | Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | baseline 1 (Week 0) | 2.7 score on a scale | Standard Deviation 0.5 |
| Sham SPR | Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | Post-assessment (Week 10) | 3.2 score on a scale | Standard Deviation 0.7 |
| Sham SPR | Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | baseline 2 (Week 2) | 2.7 score on a scale | Standard Deviation 0.6 |
Secondary
Visual Analogue Scale (VAS)-Pain
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.
Time frame: before and after each time device used up to 14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real SPR | Visual Analogue Scale (VAS)-Pain | before device use | 64.4 score on a scale | Standard Deviation 17.5 |
| Real SPR | Visual Analogue Scale (VAS)-Pain | after device use | 49.6 score on a scale | Standard Deviation 23.8 |
| Sham SPR | Visual Analogue Scale (VAS)-Pain | before device use | 55.9 score on a scale | Standard Deviation 25.6 |
| Sham SPR | Visual Analogue Scale (VAS)-Pain | after device use | 52.1 score on a scale | Standard Deviation 26.9 |
Secondary
Visual Analogue Scale (VAS)-Sleep
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.
Time frame: first 3 days and 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real SPR | Visual Analogue Scale (VAS)-Sleep | 15.7 percent change | Standard Error 1.7 |
| Sham SPR | Visual Analogue Scale (VAS)-Sleep | 6.26 percent change | Standard Error 2.5 |