Introducing the COMFORT Trial

a potential breakthrough for chronic neuropathic pain sufferers. If standard treatments have left you in discomfort, consider the COMFORT clinical trial. This trial investigates the combined efficacy of the FDA-cleared Nalu system with conventional treatments against standalone conventional treatments.

Your eligibility will be determined by your doctor at Pain Management & Injury Relief, and participating not only offers a chance for relief but also contributes to chronic pain treatment advancement. Compensation is provided for eligible participants.

ABOUT
ELIGIBILITY

The Approach

For those well-acquainted with chronic pain and its treatment avenues, peripheral nerve stimulation through the Nalu system presents a promising option. This system involves wire leads connected to a small, battery-free implantable pulse generator (micro-IPG), powered by an external Therapy Disc. By emitting mild electrical impulses, it intercepts pain signals before they reach the brain.

Device Highlights

The Nalu peripheral nerve stimulation device boasts FDA clearance for a remarkable 18-year service life—the longest among comparable devices. It’s designed for discretion, comfort, and convenience, allowing wearers to manage therapy intensity and type.

The Journey

Upon doctor approval and meeting study criteria, participants join the COMFORT trial. Random allocation includes receiving the stimulation implant or maintaining existing treatment, possibly transitioning to the implant after three months.

PHASE

1

Wearability Assessment
Participants wear an adhesive clip and non-functional Therapy Disc to identify optimal positions for comfort and lifestyle fit.

PHASE

2

Therapeutic Trial
A minimally invasive procedure places thin wires near identified nerves, connected to an external stimulator. Pain relief during the trial guides further decisions.

PHASE

3

Permanent Integration
Successful early phases lead to a minimally invasive procedure for permanent implantation of leads and the micro-IPG, with device control via a smartphone app.

Eligibility

Severe nerve-related chronic pain in the back, foot, knee, or shoulder makes you a potential candidate for the Nalu COMFORT clinical trial. Full study criteria can be found here. All safety information can be found here.

If you are interested in participating in this clinical trial, please fill out the form below:

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Am I Eligible? Learn more about requirements and exclusive here:

ELIGIBILITY