Trial Outcomes & Findings for Remote Participation (Within USA) Trial of Sana Pain Reliever (NCT NCT04280562)
NCT ID: NCT04280562
Last Updated: 2025-11-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
Results posted on
2025-11-04
Participant Flow
104 participants consented, with 75 enrolled and randomized.
Participant milestones
| Measure |
"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.
|
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.
|
|---|---|---|
|
Baseline Screening
STARTED
|
34
|
41
|
|
Baseline Screening
COMPLETED
|
34
|
41
|
|
Baseline Screening
NOT COMPLETED
|
0
|
0
|
|
Study
STARTED
|
34
|
41
|
|
Study
COMPLETED
|
29
|
38
|
|
Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
"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.
|
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.
|
|---|---|---|
|
Study
Adverse Event
|
2
|
0
|
|
Study
Lost to Follow-up
|
3
|
3
|
Baseline Characteristics
Remote Participation (Within USA) Trial of Sana Pain Reliever
Baseline characteristics by cohort
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12.7 • n=15 Participants
|
48.2 years
STANDARD_DEVIATION 15.2 • n=161 Participants
|
45.4 years
STANDARD_DEVIATION 14.4 • n=100 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=15 Participants
|
25 Participants
n=161 Participants
|
52 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants
|
16 Participants
n=161 Participants
|
23 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=15 Participants
|
32 Participants
n=161 Participants
|
58 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=15 Participants
|
7 Participants
n=161 Participants
|
13 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
8 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=15 Participants
|
25 Participants
n=161 Participants
|
48 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=15 Participants
|
9 Participants
n=161 Participants
|
17 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
Change in Neuropathic Pain Symptom Inventory (NPSI)
Post-assessment (Week 10)
|
39.6 score on a scale
Standard Deviation 21.9
|
34 score on a scale
Standard Deviation 20.3
|
|
Change in Neuropathic Pain Symptom Inventory (NPSI)
Follow up (Week 14)
|
36.6 score on a scale
Standard Deviation 21
|
39.1 score on a scale
Standard Deviation 23.1
|
|
Change in Neuropathic Pain Symptom Inventory (NPSI)
baseline 1 (Week 0)
|
47.6 score on a scale
Standard Deviation 17.2
|
41 score on a scale
Standard Deviation 20.5
|
|
Change in Neuropathic Pain Symptom Inventory (NPSI)
Baseline 2 (Week 2)
|
48.7 score on a scale
Standard Deviation 17.6
|
41.5 score on a scale
Standard Deviation 23.5
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
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
|
43.8 score on a scale
Standard Deviation 31.8
|
|
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
|
44.7 score on a scale
Standard Deviation 30.6
|
|
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
|
34.4 score on a scale
Standard Deviation 31.4
|
|
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
|
44 score on a scale
Standard Deviation 30.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
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
|
36.6 score on a scale
Standard Deviation 26.6
|
|
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
|
34.9 score on a scale
Standard Deviation 27.3
|
|
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
|
31.0 score on a scale
Standard Deviation 27.8
|
|
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain
Follow up (Week 14)
|
31.9 score on a scale
Standard Deviation 30
|
35.0 score on a scale
Standard Deviation 24.7
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
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
|
42.2 score on a scale
Standard Deviation 31.3
|
|
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
|
42.5 score on a scale
Standard Deviation 30.8
|
|
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain
Post-assessment (Week 10)
|
42.5 score on a scale
Standard Deviation 31.0
|
30.7 score on a scale
Standard Deviation 30.5
|
|
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
|
41.4 score on a scale
Standard Deviation 31.9
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
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
|
35.2 score on a scale
Standard Deviation 26.1
|
|
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
|
39.4 score on a scale
Standard Deviation 28.7
|
|
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
|
30.3 score on a scale
Standard Deviation 25.2
|
|
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
|
32.8 score on a scale
Standard Deviation 28.9
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
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
|
51.2 score on a scale
Standard Deviation 30.8
|
|
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
|
48.8 score on a scale
Standard Deviation 32.1
|
|
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
|
45.6 score on a scale
Standard Deviation 28.8
|
|
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia
Follow up (Week 14)
|
46.3 score on a scale
Standard Deviation 30.0
|
48.2 score on a scale
Standard Deviation 30.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
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
|
5.6 score on a scale
Standard Deviation 4.5
|
|
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
|
6.1 score on a scale
Standard Deviation 4.5
|
|
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
|
5.5 score on a scale
Standard Deviation 4.6
|
|
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
|
6.0 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI)
baseline 1 (Week 0)
|
9.1 score on a scale
Standard Deviation 3.8
|
10.3 score on a scale
Standard Deviation 3.8
|
|
Change in Pittsburgh Sleep Quality Index (PSQI)
baseline 2 (Week 2)
|
9.0 score on a scale
Standard Deviation 3.7
|
10.1 score on a scale
Standard Deviation 4.3
|
|
Change in Pittsburgh Sleep Quality Index (PSQI)
Post-assessment (Week 10)
|
7.4 score on a scale
Standard Deviation 4.7
|
8.0 score on a scale
Standard Deviation 5.0
|
|
Change in Pittsburgh Sleep Quality Index (PSQI)
Follow up (Week 14)
|
8.7 score on a scale
Standard Deviation 4.4
|
9.2 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
Change in Beck Depression Inventory (BDI)
Follow Up (Week 14)
|
8.6 score on a scale
Standard Deviation 7.0
|
9.0 score on a scale
Standard Deviation 7.2
|
|
Change in Beck Depression Inventory (BDI)
baseline 2 (Week 2)
|
10.0 score on a scale
Standard Deviation 7.3
|
10.0 score on a scale
Standard Deviation 7.3
|
|
Change in Beck Depression Inventory (BDI)
Post-assessment (Week 10)
|
8.8 score on a scale
Standard Deviation 7.7
|
8.3 score on a scale
Standard Deviation 6.4
|
|
Change in Beck Depression Inventory (BDI)
baseline 1 (Week 0)
|
8.6 score on a scale
Standard Deviation 6.0
|
8.0 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
Change in General Anxiety Disorder 7-item Questionnaire (GAD-7)
baseline 1 (Week 0)
|
6.4 score on a scale
Standard Deviation 4.2
|
5.0 score on a scale
Standard Deviation 3.8
|
|
Change in General Anxiety Disorder 7-item Questionnaire (GAD-7)
baseline 2 (Week 2)
|
6.3 score on a scale
Standard Deviation 3.3
|
5.7 score on a scale
Standard Deviation 4.5
|
|
Change in General Anxiety Disorder 7-item Questionnaire (GAD-7)
Post-assessment (Week 10)
|
6.0 score on a scale
Standard Deviation 5.2
|
3.9 score on a scale
Standard Deviation 3.4
|
|
Change in General Anxiety Disorder 7-item Questionnaire (GAD-7)
Follow up (Week 14)
|
5.8 score on a scale
Standard Deviation 4.3
|
4.0 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
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
|
2.7 score on a scale
Standard Deviation 0.5
|
|
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
|
2.7 score on a scale
Standard Deviation 0.6
|
|
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
|
3.2 score on a scale
Standard Deviation 0.7
|
|
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
|
3.0 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
Change in World Health Organization Quality of Life Bref (WHOQOL-BREF)
baseline 1 (Week 0)
|
50.4 score on a scale
Standard Deviation 21.0
|
54.6 score on a scale
Standard Deviation 21.8
|
|
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
|
50.9 score on a scale
Standard Deviation 22.6
|
|
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
|
59.0 score on a scale
Standard Deviation 22.7
|
|
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
|
52.1 score on a scale
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
Change in Patient's Global Impression of Change (PGIC)
Post-assessment (Week 10)
|
2.8 score on a scale
Standard Deviation 1.9
|
2.9 score on a scale
Standard Deviation 1.9
|
|
Change in Patient's Global Impression of Change (PGIC)
Follow up (Week 14)
|
2.7 score on a scale
Standard Deviation 1.9
|
2.5 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: before and after each time device used up to 14 weeksVisual 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
Visual Analogue Scale (VAS)-Pain
after device use
|
49.6 score on a scale
Standard Deviation 23.8
|
52.1 score on a scale
Standard Deviation 26.9
|
|
Visual Analogue Scale (VAS)-Pain
before device use
|
64.4 score on a scale
Standard Deviation 17.5
|
55.9 score on a scale
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: first 3 days and 14 weeksVisual 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.
Outcome measures
| Measure |
"Real" SPR
n=34 Participants
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.
|
Sham SPR
n=41 Participants
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.
|
|---|---|---|
|
Visual Analogue Scale (VAS)-Sleep
|
15.7 percent change
Standard Error 1.7
|
6.26 percent change
Standard Error 2.5
|
Adverse Events
"Real" SPR
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham SPR
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
"Real" SPR
n=34 participants at risk
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.
|
Sham SPR
n=41 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Neuropathic Pain Event or Increase
|
8.8%
3/34 • 14 Weeks
|
2.4%
1/41 • 14 Weeks
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • 14 Weeks
|
0.00%
0/41 • 14 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place