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Peripheral NeuralgiaCOMFORTNCT05287373

Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain

A study testing Nalu Neurostimulation System for PNS and conventional medical management in people with Peripheral Neuralgia and Chronic Pain, run by Nalu Medical, Inc. at 13 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 post-surgical origin. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Peripheral Neuralgia, Chronic Pain
What is being tested?
Nalu Neurostimulation System for PNS and conventional medical management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
13 sitesUnited States
Study dates
23 Feb 2022to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is between 18 to 80 years of age at the time of enrollment.
  • Subject would have been prescribed PNS therapy regardless of participation in this study; the use of the Nalu device must be on-label.
  • Subject has been diagnosed with one or more of the conditions listed below in the low back, shoulder, knee, or foot (including ankle):Post-surgical/post-traumatic peripheral neuralgia including but not limited to pain due to peripheral nerve injury, post-surgical scar formation, nerve entrapment; Mononeuropathy, specified or unspecified or in diseases classified elsewhere; Other neuralgia or neuropathic pain; Osteoarthritic pain.
  • Subject has chronic (defined as at least 6 months duration), intractable peripheral neuropathic pain, exclusive of the craniofacial region; any nociceptive pain must be less prominent than the neuropathic pain. Pain should have a predominant neuropathic component as per the investigator's clinical assessment.
  • Subject should have a pain score of at least 6, in the target area of pain, as recorded on the BPI-Q5 (NRS) at screening.
  • Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.
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  • Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.
  • Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.
  • Subject is psychologically qualified to receive a peripheral nerve stimulator as per the clinician's standard clinical practice and judgment and does not have clinically relevant psychological condition(s) that would interfere with their ability to accurately report outcomes or complete study procedures.
  • Subject has demonstrated the ability to appropriately place the adhesive clip in the location where the IPG is most likely to be implanted. Alternatively, subject is able to appropriately use the relief belt and/or limb cuff to keep the Therapy Disc in place.

Who cannot join

  • Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
  • Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant)
  • Pain is completely absent at rest.
  • Patient has clinical evidence of complex regional pain syndrome (CRPS), peripheral neuralgia of metabolic origin, post-herpetic neuralgia, biochemical evidence of a metabolic or genetic neuropathy (e.g., Charcot'- Marie- Tooth Disease) or mixed motor/sensory polyneuropathy.
  • Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
  • Subject has had a successful (≥ 50% pain relief) interventional procedure within the past 3 months to treat the same pain condition(s) being examined in this study including, nerve blocks.
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  • Uncontrolled depression or uncontrolled psychiatric disorders
  • Subject is currently participating in another clinical investigation with an active treatment arm.
  • Subject is allergic or sensitive to materials used in the device components including, skin adhesives or does not tolerate the wearable aspect of the device.
  • Subject has pending or ongoing legal issues (including unresolved worker's compensation claims or equivalent) or other conflicting secondary gain issues related to their chronic pain condition.
  • Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease that has not been medically corrected.
  • Subject has an active systemic infection.
  • Subject is unable to read and/or write in English or give informed consent.
  • Subject has a life expectancy of less than 1 year.
  • Subject has an active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome.
  • Subject with uncontrolled diabetes mellitus, showing signs of diabetic neuropathy, as evidenced by a neurological exam and a HbA1c test.
  • Subject has evidence of an alcohol or drug dependency within the last 6 months prior to enrollment.
  • Subject is pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 1 year post-menopausal).
  • Subject is nursing/breastfeeding.
  • Subject is on ≥90 mg-morphine equivalents per 24 hours.
  • Subject has undergone an ablative treatment of the target peripheral nerve, or proximal nerve trunk giving rise to the target nerve, or dorsal roots (and DRGs) that ultimately make up the target nerve. No ablative procedures directed at the spinal cord, dorsal roots, or peripheral nerve(s) being treated in the study. To note, subjects who have undergone RF ablation of the dorsal rami, cool pulsed RF of the facet innervation may be considered for enrollment.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Pain Specialists of America

    Austin, Texas, 78745

  • Comprehensive Spine & Pain Physicians

    Burbank, California, 91505

  • Institute of Precision Pain Medicine

    Corpus Christi, Texas, 78414

  • DBPS Research LLC

    Denver, Colorado, 80111

  • Pacific Sports and Spine

    Eugene, Oregon, 97401

  • University of Arkansas Interventional Spine and Pain Clinic

    Little Rock, Arkansas, 72205

  • Columbia Pain Management

    Milwaukie, Oregon, 97222

  • Stanford University Pain Management Center

    Redwood City, California, 94063

  • Arizona Pain Specialists

    Scottsdale, Arizona, 85258

  • Anesis Spine and Pain Care

    Spokane, Washington, 99216

  • Pain Management and Injury Relief

    Thousand Oaks, California, 91320

  • International Spine, Pain & Performance Center

    Washington D.C., District of Columbia, 20006

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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 post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

Being tested
Nalu Neurostimulation System for PNS, conventional medical management
Keywords
PNS, Peripheral nerve stimulation, mIPG, peripheral nerve stimulator
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nalu Neurostimulation System for PNSDevice

    Also called Nalu PNS

    The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator

  • conventional medical managementOther

    Conventional medical management

Study groups in NCT05287373
Study groupRoleWhat they receive
PNS Therapy plus Conventional Medical ManagementActive comparatorperipheral nerve stimulator plus conventional medical management
Receives: Device: Nalu Neurostimulation System for PNS; Other: conventional medical management
Conventional Medical ManagementOtherControl arm conventional medical management only
Receives: Other: conventional medical management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness: Responder rates between groups

    Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS).

    Measured: 3-months

  2. Safety: Rate of serious and non-serious adverse events between groups

    Rate of serious and non-serious adverse events between groups

    Measured: 3-months

Secondary outcomes (6)

  1. Responder Rates between groups at 6-months

    Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS).

    Measured: 6 months

  2. Responder Rates between groups at 12-months

    Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS).

    Measured: 12-months

  3. Responder Rates between groups at 24-months

    Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS).

    Measured: 24-months

  4. Responder Rates between groups at 36-months

    Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS).

    Measured: 36-months

  5. Functional Outcomes: Change in ODI, BDI, EQ-5D, BPI from baseline

    Change in patient reported outcomes from baseline between groups

    Measured: 3, 6, 9, 12, 18, 24, 30 and 36 months

  6. Safety Assessment

    Rate of serious and non-serious events

    Measured: 3, 6, 9, 12, 18, 24, 30 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start23 Feb 2022
  3. Primary completion11 Dec 2023
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05287373
Sponsor's protocol ID
NAL-01-2021-US
Acronym
COMFORT
Status last verified
Jun 2026
First submitted
8 Feb 2022
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Hatheway J, Hersel A, Engle M, Gutierrez G, Khemlani V, Kapural L, Moore G, Ajakwe R, Trainor D, Hah J, Staats PS, Makous J, Heit G, Kottalgi S, Desai MJ; COMFORT Study Group. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):278-284. doi: 10.1136/rapm-2024-106099.

    PubMed 39572166

Questions about this trial

What is this clinical trial studying?

A study testing Nalu Neurostimulation System for PNS and conventional medical management in people with Peripheral Neuralgia and Chronic Pain, run by Nalu Medical, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness: Responder rates between groups (time frame: 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05287373, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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