High Frequency PNS Stimulation Study for Back and Leg Pain

November 18, 2025 updated by: Curonix LLC

A European, Prospective, Multi-Center, Double-Blind, Randomized, Controlled, Clinical Trial Investigating the Effects of High Frequency Peripheral Nerve Stimulation (PNS) in the Treatment of Chronic Back Pain

Prospective, double blinded, randomized, clinical study investigating the effects of high frequency PNS for the treatment of chronic back or back and leg pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All subjects will have two permanent stimulators placed over the proximal peripheral nerves at T9 at the implant visit. The stimulators can easily be removed for non-responders. High frequency stimulation is typically programmed below sensory threshold. This type of stimulation lends itself to a placebo-controlled trial. For this study subjects will be randomized 1:1 at enrollment into a high frequency or sham group. Neither the subjects nor experimenters will be made aware of their randomization assignment for at least the first month of the trial. Subjects belonging to both groups will be unblinded to their assignment at the 1-month or a later visit (including unscheduled visit) if they have a VAS > 30 mms. Subjects belonging to the sham group will be reprogrammed with HF stimulation at this point. Subjects belonging to the HF stimulation group will keep stimulating with HF. Subjects reporting a VAS < 30 mms will continue to be blinded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Roeselare, Belgium, 8800
        • AZ Delta
    • Antwerpen
      • Wilrijk, Antwerpen, Belgium, 2610
        • GZA Sint-Augustinus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Subject is ≥ 18 years of age at time of informed consent;
  • Subjects have been diagnosed with predominant, chronic, intractable back pain with a VAS > 50 mm (on a 100-mm scale);
  • Subjects have been diagnosed with predominant, chronic, intractable back pain for at least 6 months before study participation;
  • Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment;
  • Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
  • Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
  • Subject is willing and able to operate the patient programmer, recharging equipment and has the ability to undergo study assessments and provide accurate responses;
  • Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;
  • Subject is male or non-pregnant female;
  • Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a clinical psychologist and principal investigator, using face-to-face encounters and the psychological testing described in the measures;
  • Patient is capable of giving informed consent.

Exclusion criteria

  • Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
  • Unresolved malignancies in the last six months;
  • Subject has post-herpetic neuralgia (shingles);
  • Subject has an active systemic infection or is immune-compromised;
  • Based on the medical opinion of the Principal Investigator the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
  • Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
  • Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
  • Bleeding complications or coagulopathy issues;
  • Pregnant/lactating or not using adequate birth control;
  • A life expectancy of less than one year;
  • Any active implanted device whether turned off or on;
  • A previous PNS experience for the treatment of back pain;
  • Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Frequency
Subjects receiving high frequency pulse rate PNS treatment at T9 proximal peripheral nerves. Subjects and assessors blinded Randomization.
Device: PNS HF
A needle and catheter is carefully inserted near your spinal column. The stimulator is then placed through the catheter and directed towards the T9 proximal peripheral nerves. The proximal end of the stimulator is then sutured underneath the skin of your back to the fascia to prevent migration.
Sham Comparator: Sham
Subjects receiving Sham (non-active) PNS treatment at T9 proximal peripheral nerves. Subjects and assessors blinded to randomization. Subjects and assessors to be unblinded if pain scores are 30 mms or higher with VAS after 1-month follow-up. Upon this moment subjects to receive active stimulation
Device: PNS Sham
A needle and catheter is carefully inserted near your spinal column. The stimulator is then placed through the catheter and directed towards the T9 proximal peripheral nerves. The proximal end of the stimulator is then sutured underneath the skin of your back to the fascia to prevent migration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Responder rate
Time Frame: 1 month post-implant
a > 50% reduction in back pain as measured by VAS with the Freedom PNS system in the HF (test) group as opposed to sham and conventional medical management
1 month post-implant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS back pain
Time Frame: 1, 3, 6, 9, 12 and 36 months
Percentage change from baseline in VAS for back pain
1, 3, 6, 9, 12 and 36 months
VAS leg pain
Time Frame: 1, 3, 6, 9, 12 and 36 months
Percentage change from baseline in VAS for leg pain
1, 3, 6, 9, 12 and 36 months
ODI
Time Frame: 1, 3, 6, 9, 12 and 36 months
Change from baseline in functionality using the ODI score
1, 3, 6, 9, 12 and 36 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PGIC
Time Frame: 1, 3, 6, 9, 12 and 36 months
Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC)
1, 3, 6, 9, 12 and 36 months
EQ-5D-5L
Time Frame: 1, 3, 6, 9, 12 and 36 months
Changes from baseline in quality of life
1, 3, 6, 9, 12 and 36 months
AE's
Time Frame: 1, 3, 6, 9, 12 and 36 months
Incidence of device related adverse events
1, 3, 6, 9, 12 and 36 months
Opioid Pain Medication
Time Frame: 1, 3, 6, 9, 12 and 36 months
Prescribed opioid pain medications
1, 3, 6, 9, 12 and 36 months
Non-opioid Pain Medication
Time Frame: 1, 3, 6, 9, 12 and 36 months
Prescribed non-opioid pain medication
1, 3, 6, 9, 12 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Curonix LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AZ Delta
GZA Ziekenhuizen Campus Sint-Augustinus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 30-004060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Publication, Study outcomes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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