Chronic Back PainNCT03312010
High Frequency PNS Stimulation Study for Back and Leg Pain
A study testing PNS HF in people with Chronic Back Pain and Chronic Back and Leg Pain, run by Curonix LLC at 2 sites in Belgium.
Trial summary
Prospective, double blinded, randomized, clinical study investigating the effects of high frequency PNS for the treatment of chronic back or back and leg pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Back Pain, Chronic Back and Leg Pain
- What is being tested?
- PNS HF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Mar 2018to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
AZ Delta
Roeselare, 8800
GZA Sint-Augustinus
Wilrijk, Antwerpen, 2610
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Back Pain, Chronic Back and Leg Pain
- Being tested
- PNS HF, PNS Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNS HFDevice
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.
PNS ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| High Frequency | Experimental | Subjects receiving high frequency pulse rate PNS treatment at T9 proximal peripheral nerves. Subjects and assessors blinded Randomization. Receives: Device: PNS HF |
| Sham | Sham comparator | 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 Receives: Device: PNS Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate
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
Measured: 1 month post-implant
Secondary outcomes (3)
VAS back pain
Percentage change from baseline in VAS for back pain
Measured: 1, 3, 6, 9, 12 and 36 months
VAS leg pain
Percentage change from baseline in VAS for leg pain
Measured: 1, 3, 6, 9, 12 and 36 months
ODI
Change from baseline in functionality using the ODI score
Measured: 1, 3, 6, 9, 12 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 Mar 2018
- Primary completion1 Aug 2019
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- Prospective, partially double-blinded, randomized
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curonix LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AZ Delta, GZA Ziekenhuizen Campus Sint-Augustinus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312010
- Sponsor's protocol ID
- 30-004060
- Status last verified
- Nov 2025
- First submitted
- 20 Jun 2017
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Publication, Study outcomes
Publications
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03312010
- Acronym / sponsor ID
- 30-004060
- Conditions
- Chronic Back Pain, Chronic Back and Leg Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Curonix LLCIndustry (pharma, biotech, devices)
- Collaborators
- AZ Delta, GZA Ziekenhuizen Campus Sint-Augustinus
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, double blinded, randomized, clinical study investigating the effects of high frequency PNS for the treatment of chronic back or back and leg pain.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, partially double-blinded, randomized
| Arm | Type | Receives |
|---|---|---|
| High Frequency | Experimental | Device: PNS HFSubjects receiving high frequency pulse rate PNS treatment at T9 proximal peripheral nerves. Subjects and assessors blinded Randomization. |
| Sham | Sham comparator | Device: PNS ShamSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNS HFA 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. | Device | High Frequency |
| PNS ShamA 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. | Device | Sham |
Primary outcome
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
3 secondary outcomes
VAS back pain
Time frame: 1, 3, 6, 9, 12 and 36 months
VAS leg pain
Time frame: 1, 3, 6, 9, 12 and 36 months
ODI
Time frame: 1, 3, 6, 9, 12 and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
- Individual participant dataSharing planned: No. Publication, Study outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNS HF in people with Chronic Back Pain and Chronic Back and Leg Pain, run by Curonix LLC at 2 sites in Belgium.
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 11 inclusion and 13 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Responder rate (time frame: 1 month post-implant). 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 NCT03312010, 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 21 Nov 2025.