High Frequency PNS Stimulation Study for Back and Leg Pain

NCT03312010 | Completed DMC FDA Device

• 1 other identifier: 30-004060
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Back Pain; Chronic Back and Leg Pain

Outcome Measures

Primary Outcomes (1)

• 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

  1 month post-implant

Secondary Outcomes (3)

• VAS back pain

  1, 3, 6, 9, 12 and 36 months

• VAS leg pain

  1, 3, 6, 9, 12 and 36 months

• ODI

  1, 3, 6, 9, 12 and 36 months

Other Outcomes (5)

• PGIC

  1, 3, 6, 9, 12 and 36 months

• EQ-5D-5L

  1, 3, 6, 9, 12 and 36 months

• AE's

  1, 3, 6, 9, 12 and 36 months

Study Arms (2)

High Frequency

EXPERIMENTAL

Subjects receiving high frequency pulse rate PNS treatment at T9 proximal peripheral nerves. Subjects and assessors blinded Randomization.

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

Device: PNS Sham

Interventions

PNS HF DEVICE

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.

High Frequency

PNS Sham DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Curonix LLC: lead
• AZ Delta: collaborator
• GZA Ziekenhuizen Campus Sint-Augustinus: collaborator

Study Sites (2)

GZA Sint-Augustinus

Wilrijk, Antwerpen, 2610, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34854473 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects and assessors randomized to HF blinded Subjects and assessors randomized to sham blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, partially double-blinded, randomized

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: October 17, 2017
• Study Start: March 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2022
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)