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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Curonix LLC
- Enrollment
- 38
- Locations
- 4
- Primary Endpoint
- Responder rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Subjects and assessors randomized to HF blinded Subjects and assessors randomized to sham blinded
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- VAS leg pain(1, 3, 6, 9, 12 and 36 months)
- VAS back pain(1, 3, 6, 9, 12 and 36 months)
- ODI(1, 3, 6, 9, 12 and 36 months)