High Frequency PNS Stimulation Study for Back and Leg Pain

NCT ID: NCT03312010

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2022-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

High Frequency

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

Group Type: EXPERIMENTAL

PNS HF

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

PNS Sham

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Delta

OTHER

Sponsor Role: collaborator

GZA Ziekenhuizen Campus Sint-Augustinus

OTHER

Sponsor Role: collaborator

Curonix LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GZA Sint-Augustinus

Wilrijk, Antwerpen, Belgium

AZ Delta

Roeselare, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 34854473 (View on PubMed)

Other Identifiers

30-004060

Identifier Type: -

Identifier Source: org_study_id