Study Summary
This trial is studying if nerve stimulation plus medical care is better than medical care alone to treat chronic nerve pain due to trauma or surgery.
- Chronic Pain
- Peripheral Neuropathy
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: 3, 6 and 12 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Conventional Medical Management
1 of 2
PNS Therapy plus Conventional Medical Management (CMM)
1 of 2
Active Control
100 Total Participants · 2 Treatment Groups
Primary Treatment: Conventional Medical Management · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Is there any opportunity for me to participate in this clinical experiment?
"In order to partake in this trial, individuals must be between 18 and 80 years old and suffer from chronic pain. A total of 100 participants are being sought after for the study." - Anonymous Online Contributor
Does this research encompass individuals aged 55 and up?
"This trial is open to individuals aged between 18 and 80 years old. There are 49 studies available for minors, while there is a total of 629 related trials catering towards the elderly population." - Anonymous Online Contributor
Is this clinical trial recruiting participants at present?
"Affirmative. As per information hosted on clinicaltrials.gov, this medical trial is actively searching for participants. It was first introduced to the public on April 28th 2023 and has since been updated as recent as May 11th 2023 - the study seeks to enrol 100 patients across 2 sites." - Anonymous Online Contributor
How many individuals are being followed in this clinical trial?
"Affirmative, the clinicaltrials.gov website alludes to this study actively seeking participants. It was initially made available on April 28th 2023 and last updated on May 11th of that same year. The investigation necessitates 100 individuals from two separate sites." - Anonymous Online Contributor
What specific objectives are being sought by this experimental protocol?
"Per the clinical trial sponsor, Nalu Medical, Inc., this medical study's primary objective over a 3-month period will be to evaluate safety by analysing serious and non-serious device effects. Secondary objectives include recording changes in Oswestry Disability Index (ODI) score from baseline with comparison between groups; assessing change in Beck's Depression Inventory (BDI) score from baseline along with comparison between two cohorts; and gauging Patient Global Impression of Change (PGIC). ODI is measured on 0-100% disability scale whereas BDI is rated from 0-63 points while PGIC uses 7 point likert scale" - Anonymous Online Contributor