Remote Participation (Within USA) Trial of Sana Pain Reliever

NCT04280562 | Completed Results FDA Device

• 1 other identifier: GCO 18-2282
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Chronic Pain; Pain

Keywords

Neuropathic pain; Pain; Wearable devices; Pain management; Neuromodulation

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• 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.

  Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• 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.

  Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• 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.

  Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• 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.

  Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• 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.

  Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

Secondary Outcomes (9)

• 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)

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• Change in Beck Depression Inventory (BDI)

  Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• 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)

• 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)

Study Arms (2)

"Real" SPR

EXPERIMENTAL

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

Device: Sana Pain Reliever

Sham SPR

SHAM COMPARATOR

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

Device: Sham SPR

Interventions

Sana Pain Reliever DEVICE

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.

"Real" SPR

Sham SPR DEVICE

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.

Sham SPR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Sana Health, Inc.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10011, United States

Location

MeSH Terms

Conditions

Neuralgia; Chronic Pain; Pain; Agnosia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Results Point of Contact

• Title: Icahn School of Medicine at Mount Sinai
• Organization: David Putrino

david.putrino@mountsinai.org

212-824-8369

Study Officials

• David Putrino, PT, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 21, 2020
• Study Start: January 31, 2020
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: November 4, 2025
• Results First Posted: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)