A Prospective, Single-Blinded, Dose-Response Study of SCS Therapy using Paraesthesia-Free Waveform Patterns in Patients with Chronic Neuropathic Low Back Pain
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Chronic Neuropathic Low Back Pain
- Sponsor
- Genesis Research Services
- Enrollment
- 27
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study was testing if a new form of spinal cord stimulation (SCS) programming can reduce chronic neuropathic low back pain. Twenty-seven patients were implanted with a stimulator and participated in the study. On average, patients had lived with low back pain for 14 years, and the average pain score before study treatment was 72 out of 100. All patients trialed up to 3 different SCS study programs in the first 14 weeks and then selected their best program for the rest of the study. Three patients dropped out of the study due to adverse events. There were no serious adverse events related to the study treatment or procedures. After 6-months of SCS treatment, pain score was reduced by 51.7 points on average, and 77% of patients had 50% or more pain relief. After 12-months, pain score was reduced by 43.9 points on average, and 65% of patients had 50% or more pain relief. Patients also had significant improvements to quality-of-life and health survey scores. At the end of the study, 83% of patients were satisfied with their treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older
- •\- Physician diagnosed neuropathic low back pain
- •\- Candidate for trial of SCS therapy
Exclusion Criteria
- •\-Meets any contraindication for SCS therapy
- •\-Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
Outcomes
Primary Outcomes
Not specified