N/A
N=15
Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation
Back Pain · Pain
Bottom Line
View on ClinicalTrials.gov: NCT03756012 ↗Enrolled (actual)
15
Serious AEs
—
Results posted
Mar 2021
Primary outcome: Primary: Effect of Pulse Widths on Pain Clinical Outcomes — 15; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Algovita Spinal Cord Stimulation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kettering Health Network
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Pulse Widths on Pain Clinical Outcomes |
15; 0 | — |
| SECONDARY Change in Targeted Pain |
15; 0 | — |
| SECONDARY Distribution of Paesthesia |
15; 0 | — |
| SECONDARY Research Participant Program Preference |
9; 6 | — |
| SECONDARY Quality of Pain Relief |
6; 5; 4; 0; 0 | — |
| SECONDARY Research Participant Pain Relief Satisfaction |
12; 3; 0; 0; 0 | — |
| SECONDARY ≥ 50% Pain Relief |
15; 0 | — |
| SECONDARY Rate of AEs |
— | — |
Summary
The purpose of this study is to evaluate the effect of pulse widths 1000 μsec on clinical outcomes during a temporary SCS trial.
Eligibility Criteria
Inclusion Criteria
- be eligible for SCS therapy according to the Algovita® SCS system Indications for Use statement
- be undergoing a SCS trial using Algovita® SCS system
- sign a valid, Institutional Review Board (IRB)-approved informed consent form.
- be 18 years of age or older when written informed consent is obtained
Exclusion Criteria
- be contraindicated for an Algovita® SCS system
- have a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
- have a life expectancy of less than 2 years
- be participating in another clinical study that would confound data analysis
- have a coexisting pain condition that might confound pain ratings
- have a significant psychiatric disorder
Data sourced from ClinicalTrials.gov (NCT03756012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.