Registry to evaluate pain relief from spinal cord stimulation devices
Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol
This study is testing how well spinal cord stimulation devices can relieve pain in patients who need them and will follow them for up to a year to see how effective the treatment is.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Cardio Surgical Partners Research network |
| Locations | 1 site (Reno, Nevada) |
| Trial ID | NCT04548375 on ClinicalTrials.gov |
What this trial studies
This registry aims to gather data on the effectiveness of spinal cord stimulation (SCS) devices for pain relief in patients who qualify for implantation. It will enroll patients with approved pain conditions and follow them for up to 12 months to assess outcomes. Additionally, it will track patients who switch to a different SCS device after losing pain relief from their initial implant. The goal is to provide insights that help physicians choose the most effective therapy based on the patient's specific pain characteristics.
Who should consider this trial
Good fit: Ideal candidates are patients eligible for SCS implants with FDA-approved indications for pain relief.
Not a fit: Patients who do not qualify for SCS implants or have conditions not covered by FDA indications may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved pain management strategies for patients using spinal cord stimulation devices.
How similar studies have performed: Other studies on spinal cord stimulation have shown promising results in pain management, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * FDA approved indications for SCS implants, for commercial and government(medicare, medi-cal etc) approved payors Exclusion Criteria: \-
Where this trial is running
Reno, Nevada
- Summit Surgery Center — Reno, Nevada, United States (Recruiting)
Study contacts
- Study coordinator: tom Gordon
- Email: tom.gordon@advarra.com
- Phone: (513) 619-1683
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.