Combining spinal fusion with neurostimulation for chronic pain relief
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
NA · SynerFuse, Inc · NCT04054401
This study is testing if adding a special nerve stimulation during spinal surgery can help people with long-lasting back and leg pain feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | SynerFuse, Inc (other) |
| Locations | 2 sites (Mishawaka, Indiana and 1 other locations) |
| Trial ID | NCT04054401 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of dorsal root ganglion (DRG) stimulation when a neurostimulator is implanted during the same procedure as spinal fixation for patients suffering from chronic back and leg pain. The intervention targets individuals requiring single-level spinal fusion and aims to assess the effectiveness of combining neurostimulation with surgical intervention. Participants must have chronic pain that has not responded to conservative treatments for at least three months. The study will monitor outcomes related to pain relief and overall patient well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with chronic, intractable lower back and/or leg pain requiring spinal fusion.
Not a fit: Patients with prior spinal fusion at the same or adjacent level, significant untreated addiction, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant pain relief and improved quality of life for patients with chronic back and leg pain.
How similar studies have performed: While the combination of spinal fusion and neurostimulation is a novel approach, similar studies have shown promise in managing chronic pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy * Have been diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 of months * At least 6 months since last surgical procedure on the spine * Be 21 years of age or older at the time of enrollment * Be willing and capable of giving informed consent * Be willing and able to comply with study-related requirements Exclusion Criteria: * Any prior spinal fusion at index or adjacent level * Pregnant * Have a life expectancy of less than 1 year * Be concomitantly participating in another clinical study * Be involved in an injury claim under current litigation * Baseline narcotic use of ≥ 100 MME per day * Significant untreated addiction to dependency producing medications * Current active implantable medical device * Cancer * Have osteoporosis * Active infection * Allergies to system components * AGE \> 80 * Expected need to undergo MRI imaging in the future * Other significant comorbidities
Where this trial is running
Mishawaka, Indiana and 1 other locations
- South Bend Orthopaedics — Mishawaka, Indiana, United States (RECRUITING)
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Study coordinator: Gabi Molnar
- Email: Gabi@SynerFuse.com
- Phone: 612-217-2914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Fusion, Radiculopathy Lumbar, Chronic Pain, Dorsal Root Ganglion, Neurostimulation, Failed Back Surgery Syndrome