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High Frequency PNS Stimulation Study for Back and Leg Pain

NCT03312010 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-11-21

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • AZ Delta

    collaborator OTHER

  • GZA Ziekenhuizen Campus Sint-Augustinus

    collaborator OTHER

  • Curonix LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-08-01
Completion
2022-12-01
FDA Device
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03312010 on ClinicalTrials.gov