Sana Pain Reliever for Neuropathic Pain

Icahn School of Medicine at Mount Sinai, New York, NY
Neuropathic Pain+2 More ConditionsSana Pain Reliever - Device
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new pain reliever for people with chronic neuropathic pain. The study is done remotely, with four visits over teleconferencing, and the study devices mailed to participants to use at home for 8-14 weeks.

Eligible Conditions
  • Neuropathic Pain
  • Chronic Pain
  • Pain

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

Week 14
Change in Beck Depression Inventory (BDI)
Change in General Anxiety Disorder 7-item questionnaire (GAD-7)
Mental Depression
Change in Pittsburgh Sleep Quality Index (PSQI)
Change in World Health Organization Quality of Life Bref (WHOQOL-BREF)
Change in World Health Organization Quality of Life Pain (WHOQOL-pain)
Week 14
Change in Patient's Global Impression of Change (PGIC)
Week 14
Week 14
Visual analogue scale (VAS)-Sleep

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

2 Treatment Groups

"Real" SPR
1 of 2
Sham SPR
1 of 2

Experimental Treatment

Non-Treatment Group

102 Total Participants · 2 Treatment Groups

Primary Treatment: Sana Pain Reliever · Has Placebo Group · N/A

"Real" SPR
Experimental Group · 1 Intervention: Sana Pain Reliever · Intervention Types: Device
Sham SPR
ShamComparator Group · 1 Intervention: Sham SPR · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline 1(week0); baseline 2 (week 2); post-assessment (week 10); follow up (week 14)

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
800 Previous Clinical Trials
509,538 Total Patients Enrolled
2 Trials studying Neuropathic Pain
29 Patients Enrolled for Neuropathic Pain
Sana Health, Inc.UNKNOWN
David Putrino, PT, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
5 Previous Clinical Trials
363 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Icahn School of Medicine at Mount Sinai100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Could you provide information on the current enrollment status of this clinical experiment?

"Indeed, the data hosted on suggests that this experiment is presently enrolling participants. Originally posted in January of 2020 and recently updated April 22nd 2022 , the medical trial seeks 100 individuals at 1 site." - Anonymous Online Contributor

Unverified Answer

Could you provide an estimate of the size of the cohort engaged in this research?

"Affirmative. displays that this experiment is actively recruiting, having first been posted on January 16th 2020 and most recently modified on April 22nd 2022. A total of 100 patients are needed for the trial to be conducted at a single medical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.