N/A
Completed N=75
Remote Participation (Within USA) Trial of Sana Pain Reliever
Source: ClinicalTrials.gov NCT04280562 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Change in Neuropathic Pain Symptom Inventory (NPSI) — 47.6; 41; 48.7; 41.5 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Neuropathic Pain Symptom Inventory (NPSI) |
47.6; 41; 48.7; 41.5; 39.6; 34 | — |
| PRIMARY Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain |
59.1; 43.8; 58.7; 44.7; 41.5; 34.4 | — |
| PRIMARY Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain |
43.5; 36.6; 47.1; 34.9; 38.8; 31.0 | — |
| PRIMARY Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain |
53.6; 42.2; 52.9; 42.5; 42.5; 30.7 | — |
| PRIMARY Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain |
36.4; 35.2; 39.5; 39.4; 33.5; 30.3 | — |
| PRIMARY Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia |
56.8; 51.2; 54.8; 48.8; 45.6; 45.6 | — |
| SECONDARY Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) |
5.8; 5.6; 7.4; 6.1; 5.9; 5.5 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) |
9.1; 10.3; 9.0; 10.1; 7.4; 8.0 | — |
| SECONDARY Change in Beck Depression Inventory (BDI) |
8.6; 8.0; 10.0; 10.0; 8.8; 8.3 | — |
| SECONDARY Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) |
6.4; 5.0; 6.3; 5.7; 6.0; 3.9 | — |
| SECONDARY Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet |
2.6; 2.7; 2.7; 2.7; 2.9; 3.2 | — |
| SECONDARY Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) |
50.4; 54.6; 51.8; 50.9; 57.7; 59.0 | — |
| SECONDARY Change in Patient's Global Impression of Change (PGIC) |
2.8; 2.9; 2.7; 2.5 | — |
| SECONDARY Visual Analogue Scale (VAS)-Pain |
64.4; 55.9; 49.6; 52.1 | — |
| SECONDARY Visual Analogue Scale (VAS)-Sleep |
15.7; 6.26 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04280562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.