Nerve Stimulation for Chronic Pain
(COMFORT 2 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Nalu Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or postsurgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

Eligibility Criteria

Adults aged 18-80 with chronic, intractable peripheral neuropathic pain not including the face, who have a pain score of at least 6 and stable pain for 60 days. They must be on consistent pain medication for 30 days and cannot have an active implantable device or certain medical conditions that would interfere with the study.

Inclusion Criteria

You are mentally ready to get a nerve stimulator and don't have any psychological conditions that would affect your ability to report your experiences or complete the study tasks.

I would have been prescribed PNS therapy even if I wasn't joining this study.

My pain level in the target area is at least a 6 out of 10.

+7 more

Exclusion Criteria

I have had a procedure to treat a nerve or its roots for pain relief.

I do not have uncontrolled depression or psychiatric disorders.

I have a diagnosed nerve pain condition like CRPS or neuropathy.

+18 more

Participant Groups

The trial is testing the Nalu Neurostimulation System plus conventional medical management against conventional medical management alone to treat chronic peripheral neuralgia from post-traumatic or postsurgical origins. It's a controlled trial where participants are randomly assigned to one of these two groups.

2Treatment groups

Active Control

Group I: PNS Therapy plus Conventional Medical Management (CMM)Active Control2 Interventions

Subjects in this arm will receive a peripheral nerve stimulator and conventional medical management

Group II: Conventional Medical ManagementActive Control1 Intervention

Subjects will receive only CMM