Conventional Medical Management for Chronic Pain

Comprehensive Spine & Pain Physicians, Burbank, CA
Chronic Pain+2 More ConditionsConventional Medical Management - Other
Eligibility
18 - 80
All Sexes

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.

Eligible Conditions
  • Chronic Pain
  • Peripheral Neuropathy

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 3, 6 and 12 months

Month 12
Functional Outcomes: Change in Beck's Depression Inventory (BDI) score from baseline
Functional Outcomes: Change in Oswestry Disability Index (ODI) score from baseline to protocol defined timepoints
Functional Outcomes: Patient Global Impression of Change (PGIC)
3-months
Effectiveness: Responder Rates between the 2 groups
Safety: Rate of serious and non-serious device effects
6 and 12 months
Safety Assessment
6-months and 12 months
Responder Rates

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Conventional Medical Management
Other
ActiveComparator Group · 1 Intervention: Conventional Medical Management · Intervention Types: Other
PNS Therapy plus Conventional Medical Management (CMM)ActiveComparator Group · 2 Interventions: Conventional Medical Management, Nalu Neurostimulation System for PNS · Intervention Types: Other, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6 and 12 months

Who is running the clinical trial?

Nalu Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
260 Total Patients Enrolled
2 Trials studying Chronic Pain
260 Patients Enrolled for Chronic Pain
Patrick MartinStudy DirectorNalu Medical, Inc.
2 Previous Clinical Trials
260 Total Patients Enrolled
2 Trials studying Chronic Pain
260 Patients Enrolled for Chronic Pain

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

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